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Courses

Quality Management (ISO 13485)
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Course Description

 

This course will help you accomplish the following goals:

  • establish an ISO 13485 and FDA-compliant Quality Management (QM) system
  • create a QM manual with the necessary policies and objectives * Identify processes and formulate standard operating procedures (SOPs)
  • repare your QM system for internal and external audits

If that sounds like a lot, it is! But Medical Device University and the Johner Institute team will guide you every step of the way. In the end, you’ll have a Quality System that is manageable for you, to help you rise above QM bureaucracy and accelerate your product timeline—all while staying prepared for any audit or inspection.

So, what are you waiting for? Let’s get started.

 

Lessons
Name Watched Assessments
chevron right Introduction to QMS and ISO 13485
About this series Not available in current plan.. Book a free demo
Basic principles Not available in current plan.. Book a free demo
The route to the QM-System Not available in current plan.. Book a free demo
Standards and regulations Not available in current plan.. Book a free demo
chevron right QM Manual
QMM 1: Quality Policy Not available in current plan.. Book a free demo
QMM 2: Quality objectives Not available in current plan.. Book a free demo
chevron right QM-System: Processes and procedures
Processes and procedures Not available in current plan.. Book a free demo
Compiling lists of SOPs Not available in current plan.. Book a free demo
Writing SOPs Not available in current plan.. Book a free demo
Writing SOPs II Not available in current plan.. Book a free demo
How to write SOPs? Not available in current plan.. Book a free demo
SOP review, communicate, train Not available in current plan.. Book a free demo
chevron right QM-System: Document Control
Basics Not available in current plan.. Book a free demo
Regulations Not available in current plan.. Book a free demo
Determining measures Not available in current plan.. Book a free demo
Writing SOPs Not available in current plan.. Book a free demo
chevron right QM-System: Development
Introduction Not available in current plan.. Book a free demo
ISO 13485 Not available in current plan.. Book a free demo
ISO 9001:2015 Not available in current plan.. Book a free demo
IEC62366:2015 Not available in current plan.. Book a free demo
IEC60601-1 Not available in current plan.. Book a free demo
IEC62304 Not available in current plan.. Book a free demo
Writing options Not available in current plan.. Book a free demo
Structure Not available in current plan.. Book a free demo
chevron right QM-System: Risk Management
SOP on Risk Management Not available in current plan.. Book a free demo
Synchronize development process Not available in current plan.. Book a free demo
chevron right QM system: Management Review
Management review regulations Not available in current plan.. Book a free demo
Writing management review SOPs Not available in current plan.. Book a free demo
chevron right QM system: Internal Audits
Introduction Not available in current plan.. Book a free demo
Regulations Not available in current plan.. Book a free demo
Writing SOPs Not available in current plan.. Book a free demo
chevron right QM system: Purchasing
Introduction Not available in current plan.. Book a free demo
Regulations Not available in current plan.. Book a free demo
Writing SOPs Not available in current plan.. Book a free demo
chevron right QM system: Feedback-Measures
Introduction Not available in current plan.. Book a free demo
Regulations Not available in current plan.. Book a free demo
Vigilance Not available in current plan.. Book a free demo
CAPA Not available in current plan.. Book a free demo
chevron right QM system: Training
Training 1: Introduction Not available in current plan.. Book a free demo
Training 2: Regulations Not available in current plan.. Book a free demo
Training 3: SOP on training Not available in current plan.. Book a free demo
FDA-approval
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Course Description

 

FDA task series

Your path to FDA approval: Welcome to our FDA approval course. You will have your first FDA filing file in your hands by the end of this course. Start right away with the first video. Our FDA expert Luca Salvatore will guide you through this course.

 

Sprints
Name Assessments
Your path to FDA approval: 1st Sprint Not available in current plan.. Book a free demo
Your path to FDA approval: 2nd sprint Not available in current plan.. Book a free demo
An introduction to the legal system according to MDR
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Course Description

 

If your product is classified as a medical device, you must meet certain regulatory requirements. In this course you will get an overview of the legal system as it pertains to medical devices and learn about important topics such as:

  • Medical device regulations
  • Essential requirements you or your product must meet
  • Conformity assessment procedures
  • Harmonized standards
  • Key differences between the European and US legal systems

 

Lessons
Name Watched Assessments
Welcome Not available in current plan.. Book a free demo
Introduction Not available in current plan.. Book a free demo
Essential requirements Not available in current plan.. Book a free demo
Classification Not available in current plan.. Book a free demo
Conformity assessment Not available in current plan.. Book a free demo
Unique Device Identification Not available in current plan.. Book a free demo
Clinical Evaluation & PMCF Not available in current plan.. Book a free demo
Post Market Surveillance Not available in current plan.. Book a free demo
Roles Not available in current plan.. Book a free demo
Quality Management Not available in current plan.. Book a free demo
Is your product a medical device?
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Course Description

 

Is your product a medical device? The answer to this crucial question will have a major impact on the way you can develop, market and service your product.

If your product falls under the definition of medical device, you have to comply with laws and standards, and implement quality management systems, software life cycle processes, usability and risk management. You must also provide comprehensive documentation.

 

 

Lessons
Name Watched Assessments
Is your device a medical device? Not available in current plan.. Book a free demo
Particularity of Software Not available in current plan.. Book a free demo
MDR for auditors
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Course Description

 

This course will provide you with the necessary background knowledge to discuss and argue confidently and at least at eye level with the people auditing you or reviewing your records.

With the suggestions provided by the videos in this course, you will find out with a higher probability and speed whether your products and QM-system actually comply with the requirements of the Medical Device Regulation 2017/745 (MDR). This gives you additional security in case you are audited, for example, during a follow-up audit or in the event that a product later becomes conspicuous on the market.

 

Lessons
Name Watched Assessments
Welcome Not available in current plan.. Book a free demo
Scope Not available in current plan.. Book a free demo
Chapter 2 Not available in current plan.. Book a free demo
Annex I, Part 1 Not available in current plan.. Book a free demo
Annex-I Software Not available in current plan.. Book a free demo
Annex II Not available in current plan.. Book a free demo
Classification Not available in current plan.. Book a free demo
Conformity Assessment Not available in current plan.. Book a free demo
Quality Management System Not available in current plan.. Book a free demo
Post Market Surveillance Not available in current plan.. Book a free demo
Roles Not available in current plan.. Book a free demo
PLM-OEM Not available in current plan.. Book a free demo
The technical file and intended use
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Course Description

 

Technical documentation is mandatory for every medical device. Get a first overview on the topic of technical documentation with this video. 

 

Lessons
Name Watched Assessments
Introduction - The Technical file Not available in current plan.. Book a free demo
Risk management according to ISO 14971
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Course Description

 

Medical device regulations tend to be in service of a single goal: to ensure safe medical devices with a positive benefit-risk ratio. It is therefore unsurprising that the notified bodies examine the risk management file most closely in technical documentation submissions and audits.

After this course, you’ll:

  • Understand the regulatory requirements for risk management
  • Learn the most relevant definitions in the context of risk management
  • Learn how to create a risk management file with all the necessary documents including: Risk Acceptance Matrix, Risk Table (with errors, hazards, risks and risk control measures), and Risk-Benefit Assessment
  • Learn how to check these documents for legal compliance

We provide templates and examples for TechDok-Pack and Premium-Platinum users to make it even easier to get started.

 

Lessons
Name Watched Assessments
An introduction to risk management Not available in current plan.. Book a free demo
Definitions Not available in current plan.. Book a free demo
Risk assessment matrix: Introduction Not available in current plan.. Book a free demo
Risk acceptance matrix: X-Axis Not available in current plan.. Book a free demo
Risk assessment matrix: Y-Axis Not available in current plan.. Book a free demo
Risk assessment matrix: Acceptance Criteria Not available in current plan.. Book a free demo
Risk Analysis: General Not available in current plan.. Book a free demo
Risk Analysis: PHA Not available in current plan.. Book a free demo
Risk Analysis: FMEA Not available in current plan.. Book a free demo
Risk Analysis: FTA Not available in current plan.. Book a free demo
Risk Analysis: Software Specifics Not available in current plan.. Book a free demo
Risk Analysis: Probabilities Not available in current plan.. Book a free demo
Risk Control Not available in current plan.. Book a free demo
Risk management: Post Production Not available in current plan.. Book a free demo
Documentation and ISO 14971: Documentation Not available in current plan.. Book a free demo
The standard for risk management: ISO 14971 Not available in current plan.. Book a free demo
The software development according to IEC 62304
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Course Description

 

Your software file demonstrates that you meet the legal requirements for medical device software lifecycle processes. A typical software file includes:

  • A software development plan
  • Requirements
  • Architecture and detailed design specifications
  • Results of unit, integration and systems testing
  • Release information
  • Other maintenance phase and issue resolution documents

After this course , you’ll know the relevant regulatory requirements (e.g., IEC 62304) and how to create these individual documents step by step.

For TechDok-Pack and Premium-Platinum members, templates with detailed instructions are available to speed up the file creation process even more.

 

Lessons
Name Watched Assessments
Software-lifecycle: Introduction Not available in current plan.. Book a free demo
Software-Lifecycle: V-Model Not available in current plan.. Book a free demo
Software requirements: Introductions Not available in current plan.. Book a free demo
Software Requirements: User Interface Not available in current plan.. Book a free demo
Software Requirements: Data Interface Not available in current plan.. Book a free demo
Software Requirements: Other Interfaces Not available in current plan.. Book a free demo
Software Requirements: Documentation, Verification Not available in current plan.. Book a free demo
Software Architecture: Introduction Not available in current plan.. Book a free demo
Software Architecture: Regulations Not available in current plan.. Book a free demo
Software Architecture: Safety Classification Not available in current plan.. Book a free demo
Software Architecture: Documentation & Verification Not available in current plan.. Book a free demo
Software-Tests: Unit-Tests Not available in current plan.. Book a free demo
Software-Tests: Integration Test Not available in current plan.. Book a free demo
Software-Tests: System Test Not available in current plan.. Book a free demo
Software file: Release Not available in current plan.. Book a free demo
Clinical evaluation according to MEDDEV 2.7/1 Rev 4
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Course Description

 

The goal of clinical evaluation is to demonstrate that your product:

  • Provides the expected benefits,
  • has the promised performance characteristics,
  • and has no unknown side effects or risks.

 

Clinical evaluation is required by law.

In this course, you will learn:

  • The regulatory requirements for clinical evaluation.
  • The content that a clinical evaluation must contain.
  • How to proceed to get this content and
  • how to document the results.

 

With clinical evaluation, you don't just want to meet regulatory requirements. You really want to be sure you are benefiting your patients and not exposing them to unnecessary risk.

 

Lessons
Name Watched Assessments
Goals of the series Not available in current plan.. Book a free demo
Basics Not available in current plan.. Book a free demo
Regulations: EU-MDR Not available in current plan.. Book a free demo
Regulation: EU-MDR-MDD Not available in current plan.. Book a free demo
Regulations: More EU Not available in current plan.. Book a free demo
Not available in current plan.. Book a free demo
Omitting Not available in current plan.. Book a free demo
General Concepts: Claims Not available in current plan.. Book a free demo
General Concepts: Process Not available in current plan.. Book a free demo
General Concepts:: Equivalence 1 Not available in current plan.. Book a free demo
General Concepts: Equivalence 2 Not available in current plan.. Book a free demo
Planning: Regulations Not available in current plan.. Book a free demo
Planning: Documentation Not available in current plan.. Book a free demo
Planning: Evaluation criteria Not available in current plan.. Book a free demo
Literature: Sources Not available in current plan.. Book a free demo
Literature: Search Not available in current plan.. Book a free demo
Literature: Process Not available in current plan.. Book a free demo
Literature: Individual evaluation Not available in current plan.. Book a free demo
Literature: Conclusions Not available in current plan.. Book a free demo
Concepts: Medical Writing Not available in current plan.. Book a free demo
Concepts: Interfaces 1 Not available in current plan.. Book a free demo
Concepts: Interfaces 2 Not available in current plan.. Book a free demo
Computer System Validation
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Course Description

 

Authorities and notified bodies are increasingly making Computer System Validation (CSV) the subject of audits.

This course will introduce you to the world of CSV and equip you to perform validation on your own, and shine in audits. In addition to the actual process of validation, you will also learn about the regulations that require CSV.

 

Lessons
Name Watched Assessments
Computer System Validation - An introduction Not available in current plan.. Book a free demo
Definitions 1 Not available in current plan.. Book a free demo
Definitions 2 Not available in current plan.. Book a free demo
Regulations: EU Not available in current plan.. Book a free demo
Regulations: USA Not available in current plan.. Book a free demo
Regulations: Rest of the world Not available in current plan.. Book a free demo
The CSV process: Overview Not available in current plan.. Book a free demo
The CSV process: Intended purpose and validation requirement Not available in current plan.. Book a free demo
The CSV process: Criticality Not available in current plan.. Book a free demo
The CSV process: The validation plan Not available in current plan.. Book a free demo
The CSV process: Test specifications Not available in current plan.. Book a free demo
The CSV process: The execution and documentation of tests Not available in current plan.. Book a free demo
IT security for medical devices
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Course Description

 

IT security is a prerequisite for medical devices to be used safely and deliver their promised benefits.
This course covers regulatory requirements, as well as methods to identify, avoid and eliminate security vulnerabilities.

 

Lessons
Name Watched Assessments
Overview Not available in current plan.. Book a free demo
Definitions Not available in current plan.. Book a free demo
Safety objectives Not available in current plan.. Book a free demo
Context Not available in current plan.. Book a free demo
Regulations: An overview Not available in current plan.. Book a free demo
Regulations: IT security and EU laws Not available in current plan.. Book a free demo
Regulations: Harmonized standards Not available in current plan.. Book a free demo
Regulations: FDA Not available in current plan.. Book a free demo
Analysis of vulnerabilities: Overview Not available in current plan.. Book a free demo
Analysis of vulnerabilities: Objects Not available in current plan.. Book a free demo
Analysis of vulnerabilities: Threats Not available in current plan.. Book a free demo
Vulnerability Analysis Methods: Checklists Not available in current plan.. Book a free demo
Vulnerability Analysis Methods: More checklists Not available in current plan.. Book a free demo
Vulnerability Analysis Methods: Your own data Not available in current plan.. Book a free demo
Vulnerability Analysis Methods: Input-output analysis Not available in current plan.. Book a free demo
Penetration testing: Procedure Not available in current plan.. Book a free demo
Penetration testing: Brute Force Not available in current plan.. Book a free demo
Penetration testing: Reverse Engineering Not available in current plan.. Book a free demo
Usability engineering according to IEC 62366-1
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Course Description

 

In this chapter, you’ll learn how to create an FDA-compliant usability file that includes all the necessary documents from the use specification to the summative study report. But that’s just the beginning. While the usability validation process is necessary to comply with regulatory requirements, it can also help you develop products that your customers truly love.

Companies that gather precise customer requirements become market leaders—but you can’t get requirements by simply asking for them. Medical Device University has one of the world's best usability engineers in Thomas Geis, who will put you on track to develop usable products by systematically identifying customer requirements and deriving use scenarios and user interfaces from them.

TechDok-Pack and Premium-Platinum members get pre-filled templates with detailed instructions to speed up the file creation process even more. All members can learn from the best with access to our video training series.

 

Lessons
Name Watched Assessments
Basics: Introduction Not available in current plan.. Book a free demo
Basics: Definition of terms Not available in current plan.. Book a free demo
Basics: Regulations Not available in current plan.. Book a free demo
Basics: Process Not available in current plan.. Book a free demo
IEC 62366-1: Part 1 Not available in current plan.. Book a free demo
IEC 62366-1: Part 2 - Subclause 5.1 Not available in current plan.. Book a free demo
IEC 62366-1: Part 3 - Risk management Not available in current plan.. Book a free demo
IEC 62366-1: Part 4 - UI specification Not available in current plan.. Book a free demo
IEC 62366-1: Part 5 - UI Evaluation Not available in current plan.. Book a free demo
IEC 62366-1: Part 6 - UOUP Not available in current plan.. Book a free demo
IEC 62366-1: Part 7 - Documentation Not available in current plan.. Book a free demo
Methods 1: Overview Not available in current plan.. Book a free demo
Methods 2: Prototyping Not available in current plan.. Book a free demo
Methods 3: Formative procedures Not available in current plan.. Book a free demo
Methods 4: Usability tests Not available in current plan.. Book a free demo
Context methods 1: Overview Not available in current plan.. Book a free demo
Regulatory Basics
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Course Description

 

With this short introduction into regulatory requirements, we would like to provide some guidance for deciding whether your product is a medical device or IVD or not. This is called qualification.

In this context, it is important that you precisely define the intended use and intended purpose of your device.

We also would like to give some insights on classification. This classification has a distinct impact on the efforts you make to approve your device.

Finally, you will learn some of the general safety and performance requirements.

 

 

Lessons
Name Watched Assessments
Introduction Not available in current plan.. Book a free demo
Intended Use and Intended Purpose Not available in current plan.. Book a free demo
Classification Not available in current plan.. Book a free demo
General Safety and Performance Requirements Not available in current plan.. Book a free demo

Lessons

Name Course Watched Assessments

Templates

Letter
Name Comment Information EN Latest update
chevron Technical File (TF) closed folder
TF-FOR-03-EN_MDR-Checklist Not available in current plan.. Book a free demo
TF-FOR-04-EN_Classification-MDR Not available in current plan.. Book a free demo
TF-FOR-05-EN_IVDD-Checklist Not available in current plan.. Book a free demo
TF-FOR-06-EN_IVDR-Checklist-Annex_I Not available in current plan.. Book a free demo
TF-FOR-07-EN_IVDD-IVDR-Gap-Analysis (Excel) Not available in current plan.. Book a free demo
TF-FOR-08-EN_IVDR-Checklist-Annex_II_III Not available in current plan.. Book a free demo
TF-FOR-09-EN_Classification-IVDR Not available in current plan.. Book a free demo
TF-TPL-05-EN_Declaration-of-Conformity Not available in current plan.. Book a free demo
TF-TPL-06-EN_System-Overview-IVD Not available in current plan.. Book a free demo
TF-LIS-01-EN_CE-marked-Devices Not available in current plan.. Book a free demo
chevron Design Input (DI) closed folder
DI-FOR-01-EN_Checklist-Stakeholder-Requirements Not available in current plan.. Book a free demo
DI-TPL-01-EN_Indended-Use Not available in current plan.. Book a free demo
DI-TPL-02-EN_Stakeholder-Requirements Not available in current plan.. Book a free demo
DI-TPL-03-EN_Intended-Purpose-IVD Not available in current plan.. Book a free demo
chevron Software File (SW) closed folder
SW-FOR-01-EN_Software-Requirements-Specification-Checklist Not available in current plan.. Book a free demo
SW-FOR-02-EN_Software-Architecture-Checklist Not available in current plan.. Book a free demo
SW-FOR-05-EN_Software-Release Not available in current plan.. Book a free demo
SW-FOR-06-EN_Code-Review-Checklist Not available in current plan.. Book a free demo
SW-FOR08-EN_Template-Design-Review Not available in current plan.. Book a free demo
SW-FOR-09-EN_Software-Safety-Classification Not available in current plan.. Book a free demo
SW-FOR-10-EN_DiGA-Requirements-Checklist Not available in current plan.. Book a free demo
SW-TPL-01-EN_SW-Development-Plan Not available in current plan.. Book a free demo
SW-TPL-02-EN_Configuration-Management-Plan Not available in current plan.. Book a free demo
SW-TPL-03-EN_Software-Requirements-Specification Not available in current plan.. Book a free demo
SW-TPL-04-EN_Software-Architecture Not available in current plan.. Book a free demo
SW-TPL-06-EN_System-Test-Protocol Not available in current plan.. Book a free demo
SW-TPL-06-EN_System-Test-Protocol (Excel) Not available in current plan.. Book a free demo
SW-TPL-07-EN_Machine-Learning Not available in current plan.. Book a free demo
SW-TPL-08-EN_Software-Description Not available in current plan.. Book a free demo
SW-TPL-09-EN_Cybersecurity-Documentation Not available in current plan.. Book a free demo
SW-TPL-10-EN_Software-Full-Report Not available in current plan.. Book a free demo
chevron Risk Management File (RM) closed folder
RM-TPL-00-EN_Riskmanagement-File Not available in current plan.. Book a free demo
RM-TPL-01-EN_Risk-Management-Plan Not available in current plan.. Book a free demo
RM-TPL-02-EN_Risk-Management-Acceptance-Analysis-Assessment (Excel) Not available in current plan.. Book a free demo
RM-TPL-03-EN_Risk-Management-Report_compact Not available in current plan.. Book a free demo
RM-TPL-04-EN_Risk-Management-Report_detailed Not available in current plan.. Book a free demo
RM-TPL-05-EN_Risk-Management-Table_IVD Not available in current plan.. Book a free demo
RM-TPL-06-EN_Risk-Management-Table-IVD-Production Not available in current plan.. Book a free demo
RM-FOR-01-EN_Checklist-Risk-Management-Plan Not available in current plan.. Book a free demo
RM-FOR-02-EN_Checklist-Risk-Management-Analysis-and-Evaluation Not available in current plan.. Book a free demo
RM-FOR-03-EN_Checklist-Risk-Management-Report Not available in current plan.. Book a free demo
RM-FOR-04-EN_PHA-TR24917-2020 Not available in current plan.. Book a free demo
RM-FOR-05-EN_Hazard-Examples-ISO14971-2019 Not available in current plan.. Book a free demo
chevron Usability File / Human factors (HF) closed folder
HF-TPL-01-EN_Usability-Engineering-File-UEF Not available in current plan.. Book a free demo
HF-TPL-02-EN_Usability-Evaluation-Plan-UP Not available in current plan.. Book a free demo
HF-TPL-03-EN_Usability-Evaluation-Protocol-UEP Not available in current plan.. Book a free demo
HF-TPL-04-EN_Usability-Evaluation-Summary-Report-UESR Not available in current plan.. Book a free demo
HF-TPL-05-EN_Usability-Engineering-File-UEF-UOUP Not available in current plan.. Book a free demo
chevron Clinical Evaluation (CE) closed folder
CE-TPL-01-EN_Clinical-Evaluation-Report Not available in current plan.. Book a free demo
CE-TPL-02-EN_Clinical-Evaluation-Plan Not available in current plan.. Book a free demo
CE-TPL-04-EN_SSCP Not available in current plan.. Book a free demo
CE-TPL-05-EN_Literature-search-protocol (Excel) Not available in current plan.. Book a free demo
CE-TPL-06-EN_Declaration-of-Interests Not available in current plan.. Book a free demo
CE-TPL-12-EN_Literature-search-report Not available in current plan.. Book a free demo
CE-TPL-13-EN_Demonstration-of-Equivalence (Excel) Not available in current plan.. Book a free demo
CE-TPL-16-EN_Clinical-Evaluation-Plan_SW Not available in current plan.. Book a free demo
CE-TPL-17-EN_Clinical-Evaluation-Report_SW Not available in current plan.. Book a free demo
chevron Post-Market-Clinical-Follow-Up (CF) closed folder
CF-TPL-01-EN_PMCF-Plan Not available in current plan.. Book a free demo
CF-TPL-02-EN_PMCF-Report Not available in current plan.. Book a free demo
chevron Development (PD) closed folder
PD-TPL-01-EN_Design-and-development-plan-IVD Not available in current plan.. Book a free demo
PD-TPL-02-EN-Product-Requirements-Specification-IVD Not available in current plan.. Book a free demo
PD-TPL-03-EN_Product-Design-Specification-IVD-Assay Not available in current plan.. Book a free demo
PD-LIS-01-EN_Checklist-Product-Development-IVD (Excel) Not available in current plan.. Book a free demo
PD-FOR-01-EN_Design-Review-Checklist-IVD Not available in current plan.. Book a free demo
PD-FOR-02-EN_Design-Freeze-IVD Not available in current plan.. Book a free demo
PD-FOR-03-EN_Design-Transfer-IVD Not available in current plan.. Book a free demo
PD-FOR-04-EN_IVD-Release-Product-Development Not available in current plan.. Book a free demo
PD-TPL-04-EN_Design-and-development-plan Not available in current plan.. Book a free demo
PD-TPL-05-EN_Product-requirement-specification Not available in current plan.. Book a free demo
PD-TPL-06-EN_Product-Design-Specification Not available in current plan.. Book a free demo
PD-LIS-02-EN_Traceability-Product-Development Not available in current plan.. Book a free demo
PD-FOR-05-EN_Design-Review-Checklist Not available in current plan.. Book a free demo
PD-FOR-06-EN_Design-Freeze Not available in current plan.. Book a free demo
PD-FOR-07-EN_Design-Transfer Not available in current plan.. Book a free demo
PD-FOR-08-EN_Release-Product-Development Not available in current plan.. Book a free demo
chevron IVD-Performance Evaluation (PE) closed folder
PE-TPL-01-EN_Performance-Evaluation-Plan Not available in current plan.. Book a free demo
PE-TPL-02-EN_Performance-Evaluation-Report Not available in current plan.. Book a free demo
PE-TPL-03-EN_Literature-Search-Report Not available in current plan.. Book a free demo
PE-TPL-04-EN_Scientific-Validity-Report Not available in current plan.. Book a free demo
PE-TPL-05-EN_Analytical-Performance-Plan Not available in current plan.. Book a free demo
PE-TPL-06-EN_Analytical-Performance-Report Not available in current plan.. Book a free demo
PE-TPL-07-EN_Analytical-Performance-Plan_SW Not available in current plan.. Book a free demo
PE-TPL-10-EN_PMPF-Plan Not available in current plan.. Book a free demo
PE-TPL-11-EN_PMPF-Report Not available in current plan.. Book a free demo
PE-TPL-12-EN_Stability-Testing-Plan Not available in current plan.. Book a free demo
PE-FOR-01-EN_Literature-search-protocol (Excel) Not available in current plan.. Book a free demo
chevron Labeling (LA) closed folder
LA-TPL-01-EN_Checklist-Label-Product-Packaging Not available in current plan.. Book a free demo
LA-TPL-02-EN_Template-IFU-MDR Not available in current plan.. Book a free demo
LA-TPL-03-EN_Checklist-IFU Not available in current plan.. Book a free demo
Name Comment Information EN Latest update
chevron QM-Manual (QM) closed folder
QM-QM-01-EN_QM-Manual Not available in current plan.. Book a free demo
QM-QM-02-EN_Quality-Policy Not available in current plan.. Book a free demo
QM-QM-03-EN_Quality-Objectives Not available in current plan.. Book a free demo
chevron Management Review & Audit (MR / IA / UA) closed folder
MR-SOP-01-EN_Management-Review Not available in current plan.. Book a free demo
MR-SOP-02-EN_Data-Analysis Not available in current plan.. Book a free demo
MR-TPL-01-EN_Management-Review-Report Not available in current plan.. Book a free demo
MR-FOR-01-EN_Data-Analysis Not available in current plan.. Book a free demo
IA-SOP-01-EN_Internal-Audit Not available in current plan.. Book a free demo
IA-LIS-01-EN_Action-Plan (Excel)  Not available in current plan.. Book a free demo
IA-TPL-01-EN_Audit-Program Not available in current plan.. Book a free demo
IA-TPL-02-EN_Audit-Plan Not available in current plan.. Book a free demo
IA-TPL-03-EN_Audit-Report Not available in current plan.. Book a free demo
UA-SOP-01-EN_Unannounced-Audits Not available in current plan.. Book a free demo
chevron Corrective and preventive actions (CA) closed folder
CA-SOP-01-EN_Corrective-and-Preventive-Actions Not available in current plan.. Book a free demo
CA-FOR-01-EN_CAPA-Form Not available in current plan.. Book a free demo
CA-LIS-01-EN_CAPA-List (Excel)  Not available in current plan.. Book a free demo
chevron Document & Record Control (DC) closed folder
DC-SOP-01-EN_Control-of-Documents-and-Records Not available in current plan.. Book a free demo
DC-LIS-01-EN_SOP-Checklist Not available in current plan.. Book a free demo
DC-LIS-02-EN_Processes-Documentation-ISO-13485-MDR Not available in current plan.. Book a free demo
DC-LIS-03-EN_Glossary Not available in current plan.. Book a free demo
DC-LIS-04-EN_Document-List (Excel)  Not available in current plan.. Book a free demo
DC-FOR-01-EN_Document-Review Not available in current plan.. Book a free demo
DC-TPL-01-EN_SOP-Template Not available in current plan.. Book a free demo
DC-TPL-02-EN_List-Template (Excel)  Not available in current plan.. Book a free demo
chevron Human Resources & Training (HR) closed folder
HR-SOP-01-EN_Recruiting-and-Training Not available in current plan.. Book a free demo
HR-TPL-01-EN-Job-Description Not available in current plan.. Book a free demo
HR-FOR-01-EN_Training-Record Not available in current plan.. Book a free demo
HR-FOR-02-EN_Effectiveness-Check Not available in current plan.. Book a free demo
HR-FOR-03-EN_Privacy-Statement Not available in current plan.. Book a free demo
HR-FOR-04-EN-Training_Plan Not available in current plan.. Book a free demo
chevron Infrastructure (IS) closed folder
IS-SOP-01-EN_Computer-System-Validation Not available in current plan.. Book a free demo
IS-SOP-02-EN_Measuring-Equipment Not available in current plan.. Book a free demo
IS-SOP-03-EN_Control-and-Monitoring-of-Work-Environment Not available in current plan.. Book a free demo
IS-LIS-01-EN_List-of-Computerized-Systems Not available in current plan.. Book a free demo
IS-LIS-01-EN_List-of-Computerized-Systems (Excel) Not available in current plan.. Book a free demo
IS-LIS-02-EN_List-of-measuring-instruments Not available in current plan.. Book a free demo
IS-LIS-02-EN_List-of-measuring-instruments (Excel) Not available in current plan.. Book a free demo
IS-TPL-01-EN_Evaluation-Computerized-Systems Not available in current plan.. Book a free demo
IS-TPL-02-EN-Validation-Plan Not available in current plan.. Book a free demo
IS-TPL-03-EN_Test-protocol Not available in current plan.. Book a free demo
IS-TPL-03-EN_Test-protocol (Excel) Not available in current plan.. Book a free demo
IS-TPL-04-EN_Validation-Report Not available in current plan.. Book a free demo
IS-TPL-05-EN_Work-environment-conditions-Product Not available in current plan.. Book a free demo
chevron Development and Product Management closed folder
CE-SOP-01-EN_Clinical-Evaluation Not available in current plan.. Book a free demo
PD-SOP-01-EN_Problem-Resolution Not available in current plan.. Book a free demo
PD-SOP-02-EN_Product-Development-IVD-Assay-Instrument Not available in current plan.. Book a free demo
PD-SOP-03-EN_Product-Development Not available in current plan.. Book a free demo
RM-SOP-01-EN_Risk-Management Not available in current plan.. Book a free demo
RM-SOP-02-EN_Riskmanagement-IVD Not available in current plan.. Book a free demo
RM-SOP-03-EN Not available in current plan.. Book a free demo
PE-SOP-01-EN_Performance-Evaluation Not available in current plan.. Book a free demo
HF-SOP-01-EN_Usability-Engineering-Process Not available in current plan.. Book a free demo
SW-SOP-01-EN_Software-Development Not available in current plan.. Book a free demo
CF-SOP-01-EN_Post-Market-Clinical-Follow-Up Not available in current plan.. Book a free demo
BC-SOP-01-EN_Biocompatibility-assessment Not available in current plan.. Book a free demo
chevron Supplier Management & Procurement (SA, PS) closed folder
SA-SOP-01-EN_Tendering-and-Sales Not available in current plan.. Book a free demo
SA-TPL-01-EN_Non-Disclosure-Agreement Not available in current plan.. Book a free demo
PS-SOP-01-EN_Purchase Not available in current plan.. Book a free demo
PS-SOP-02-EN_Supplier-Selection-and-Evaluation Not available in current plan.. Book a free demo
PS-SOP-03-EN_Supplier-Surveillance Not available in current plan.. Book a free demo
PS-LIS-01-EN_Supplier-List (Excel) Not available in current plan.. Book a free demo
PS-FOR-01-EN_Supplier-Evaluation Not available in current plan.. Book a free demo
PS-FOR-02-EN_Checklist-Incoming-Goods-Distributors Not available in current plan.. Book a free demo
PS-FOR-03-EN_Checklist-Incoming-Goods-Importers Not available in current plan.. Book a free demo
PS-TPL-01-EN_QAA Not available in current plan.. Book a free demo
chevron Production & Service Delivery (SU, PR, LA) closed folder
PR-SOP-01-EN_Production Not available in current plan.. Book a free demo
PR-TPL-01-EN_Production-run-sheet_Product_X Not available in current plan.. Book a free demo
PR-SOP-02-EN_Non-Conforming-Products Not available in current plan.. Book a free demo
LA-SOP-02-EN_UDI-Labeling-Tracking Not available in current plan.. Book a free demo
LA-LIS-01-EN_Device-identifiers (Excel) Not available in current plan.. Book a free demo
SU-SOP-01-EN_Support Not available in current plan.. Book a free demo
chevron Change Management (CC) closed folder
CC-SOP-01-EN_Change-Management Not available in current plan.. Book a free demo
CC-FOR-01-EN_Change-Request Not available in current plan.. Book a free demo
CC-LIS-01-EN_Change-List (Excel) Not available in current plan.. Book a free demo
chevron Post-Market Surveillance, Feedback (CH, PM) closed folder
CH-SOP-01-EN_Complaint-Handling Not available in current plan.. Book a free demo
PM-SOP-01-EN_Post-Market-Surveillance Not available in current plan.. Book a free demo
PM-SOP-02-EN_Post-Market-Surveillance-IVD Not available in current plan.. Book a free demo
PM-TPL-01-EN_PMS-Report Not available in current plan.. Book a free demo
PM-TPL-05-EN_PMS-Report-IVD Not available in current plan.. Book a free demo
PM-TPL-02-EN_PSUR Not available in current plan.. Book a free demo
PM-TPL-06-EN_PSUR-IVD Not available in current plan.. Book a free demo
PM-TPL-03-EN_PMS-Plan Not available in current plan.. Book a free demo
PM-TPL-07-EN_PMS-Plan-IVD Not available in current plan.. Book a free demo
PM-TPL-04-EN_Market-Analysis (Excel)  Not available in current plan.. Book a free demo
PM-TPL-08-EN_Data-search-protocol (Excel) Not available in current plan.. Book a free demo
chevron Authorities and Regulatory Affairs (TF, RU, VI) closed folder
TF-SOP-02-EN_Product-Release-FDA Not available in current plan.. Book a free demo
TF-SOP-03-EN_Placing-on-the-market-MDR Not available in current plan.. Book a free demo
TF-SOP-04-EN_Placing-on-the-market-IVDR Not available in current plan.. Book a free demo
VI-SOP-02-EN_Incident-Reporting-USA Not available in current plan.. Book a free demo
VI-SOP-03-EN_Reporting-of-Incidents-and-FSCA-EU Not available in current plan.. Book a free demo
VI-FOR-02-EN_Incident-Reporting_USA Not available in current plan.. Book a free demo
VI-FOR-03-EN_Incident-Evaluation-EU Not available in current plan.. Book a free demo
RU-SOP-01-EN_Regulatory-Update Not available in current plan.. Book a free demo
RU-LIS-01-EN_List-of-regulations-to-be-monitored Not available in current plan.. Book a free demo