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Courses

Quality Management (ISO 13485)
0%
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.. Upgrade
Basic principles Not available in current plan.. Upgrade
The route to the QM-System Not available in current plan.. Upgrade
Standards and regulations Not available in current plan.. Upgrade
chevron right QM Manual
Quality Policy Not available in current plan.. Upgrade
Quality objectives Not available in current plan.. Upgrade
chevron right QM-System: Processes and procedures
Processes and procedures Not available in current plan.. Upgrade
Compiling lists of SOPs Not available in current plan.. Upgrade
Writing SOPs Not available in current plan.. Upgrade
Writing SOPs II Not available in current plan.. Upgrade
How to write SOPs? Not available in current plan.. Upgrade
SOP review, communicate, train Not available in current plan.. Upgrade
chevron right SOP Document Control
Basics Not available in current plan.. Upgrade
Regulations Not available in current plan.. Upgrade
Determining measures Not available in current plan.. Upgrade
Writing SOPs Not available in current plan.. Upgrade
chevron right SOP Development
Introduction Not available in current plan.. Upgrade
ISO 13485 Not available in current plan.. Upgrade
ISO 9001:2015 Not available in current plan.. Upgrade
IEC62366:2015 Not available in current plan.. Upgrade
IEC60601-1 Not available in current plan.. Upgrade
IEC62304 Not available in current plan.. Upgrade
Writing options Not available in current plan.. Upgrade
Structure Not available in current plan.. Upgrade
chevron right SOP Risk Management
SOP on Risk Management Not available in current plan.. Upgrade
Synchronize development process Not available in current plan.. Upgrade
chevron right SOP Management Review
Management review regulations Not available in current plan.. Upgrade
Writing management review SOPs Not available in current plan.. Upgrade
chevron right SOP Internal Audits
Introduction Not available in current plan.. Upgrade
Regulations Not available in current plan.. Upgrade
Writing SOPs Not available in current plan.. Upgrade
chevron right SOP Purchasing
Introduction Not available in current plan.. Upgrade
Regulations Not available in current plan.. Upgrade
Writing SOPs Not available in current plan.. Upgrade
chevron right SOP Feedback-Measures
Introduction Not available in current plan.. Upgrade
Regulations Not available in current plan.. Upgrade
Vigilance Not available in current plan.. Upgrade
CAPA Not available in current plan.. Upgrade
chevron right SOP Training
Introduction Not available in current plan.. Upgrade
Regulations Not available in current plan.. Upgrade
SOP on training Not available in current plan.. Upgrade
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.. Upgrade
Your path to FDA approval: 2nd sprint Not available in current plan.. Upgrade
Your path to FDA approval: 3rd Sprint Not available in current plan.. Upgrade
Introduction to the legal system according to MDD
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Course Description

 

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

  • Medical device directives
  • 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
The Regulatory Landscape in a Nutshell Not available in current plan.. Upgrade
Legal System Not available in current plan.. Upgrade
Medical Device Directive Not available in current plan.. Upgrade
Essential Requirements Not available in current plan.. Upgrade
Classification Not available in current plan.. Upgrade
Conformity Assessment Not available in current plan.. Upgrade
Technical Documentation Not available in current plan.. Upgrade
Entire Process Not available in current plan.. Upgrade
Standards-Overall-Picture Not available in current plan.. Upgrade
Differences-FDA-EU Not available in current plan.. Upgrade
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 chapter 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.. Upgrade
Introduction Not available in current plan.. Upgrade
Essential requirements Not available in current plan.. Upgrade
Classification Not available in current plan.. Upgrade
Conformity assessment Not available in current plan.. Upgrade
Unique Device Identification Not available in current plan.. Upgrade
Clinical Evaluation & PMCF Not available in current plan.. Upgrade
Post Market Surveillance Not available in current plan.. Upgrade
Roles Not available in current plan.. Upgrade
Quality Management Not available in current plan.. Upgrade
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.. Upgrade
Particularity of Software Not available in current plan.. Upgrade
MDR for auditors
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Course Description

 

Adverse events and product problems happen. It’s important to have a good understanding of whether your QM system is fully compliant with Medical Device Reporting (MDR) requirements, and how to get there.

This video series will give you the knowledge you need to communicate confidently in case of an audit or review of your records.

 

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

 

A precisely formulated statement of intended use is necessary to:

  • Classify your product as a medical device or non-medical device
  • Determine applicable regulations and guidelines
  • Determine a medical device class (I, IIa, IIb, III)
  • Identify use-related risks and risk acceptance
  • Establish the usability file

This chapter shows you which regulatory requirements you need to consider when writing the intended use statement for your device, including a chapter structure. TechDok-Pack and Premium Platinum members even have access to a pre-filled template!

 

Lessons
Name Watched Assessments
Introduction - The Technical file Not available in current plan.. Upgrade
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 chapter, you’ll:

  • Understand the regulatory requirements for risk management
  • Understand how risk management interacts with clinical evaluation
  • Learn how to create a risk management file with all the necessary documents including: Risk Acceptance Matrix, Risk Table (with errors, hazards, risks and actions), and Risk-Benefit Assessment
  • Learn how to check these documents for legal compliance For premium members,

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.. Upgrade
Definitions Not available in current plan.. Upgrade
Risk assessment matrix: Introduction Not available in current plan.. Upgrade
Risk acceptance matrix: X-Axis Not available in current plan.. Upgrade
Risk assessment matrix: Y-Axis Not available in current plan.. Upgrade
Risk assessment matrix: Acceptance Criteria Not available in current plan.. Upgrade
Risk Analysis: General Not available in current plan.. Upgrade
Risk Analysis: PHA Not available in current plan.. Upgrade
Risk Analysis: FMEA Not available in current plan.. Upgrade
Risk Analysis: FTA Not available in current plan.. Upgrade
Risk Analysis: Software Specifics Not available in current plan.. Upgrade
Risk Analysis: Probabilities Not available in current plan.. Upgrade
Risk Control Not available in current plan.. Upgrade
Risk management: Post Production Not available in current plan.. Upgrade
Documentation and ISO 14971: Documentation Not available in current plan.. Upgrade
Documentation and ISO 14971: ISO 14971 Not available in current plan.. Upgrade
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 chapter, 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, pre-filled 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.. Upgrade
Software-Lifecycle: V-Model Not available in current plan.. Upgrade
Software requirements: Introductions Not available in current plan.. Upgrade
Software Requirements: User Interface Not available in current plan.. Upgrade
Software Requirements: Data Interface Not available in current plan.. Upgrade
Software Requirements: Other Interfaces Not available in current plan.. Upgrade
Software Requirements: Documentation, Verification Not available in current plan.. Upgrade
Software Architecture: Introduction Not available in current plan.. Upgrade
Software Architecture: Regulations Not available in current plan.. Upgrade
Software Architecture: Safety Classification Not available in current plan.. Upgrade
Software Architecture: Documentation & Verification Not available in current plan.. Upgrade
Software-Tests: Unit-Tests Not available in current plan.. Upgrade
Software-Tests: Integration Test Not available in current plan.. Upgrade
Software-Tests: System Test Not available in current plan.. Upgrade
Software file: Release Not available in current plan.. Upgrade
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 chapter 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.. Upgrade
Definitions 1 Not available in current plan.. Upgrade
Definitions 2 Not available in current plan.. Upgrade
Regulations: EU Not available in current plan.. Upgrade
Regulations: USA Not available in current plan.. Upgrade
Regulations: Rest of the world Not available in current plan.. Upgrade
The CSV process: Overview Not available in current plan.. Upgrade
The CSV process: Intended purpose and validation requirement Not available in current plan.. Upgrade
The CSV process: Criticality Not available in current plan.. Upgrade
The CSV process: The validation plan Not available in current plan.. Upgrade
The CSV process: Test specifications Not available in current plan.. Upgrade
The CSV process: The execution and documentation of tests Not available in current plan.. Upgrade
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 series of training videos covers regulatory requirements, as well as methods to identify, avoid and eliminate security vulnerabilities.

 

Lessons
Name Watched Assessments
Overview Not available in current plan.. Upgrade
Definitions Not available in current plan.. Upgrade
Safety objectives Not available in current plan.. Upgrade
Context Not available in current plan.. Upgrade
Regulations: An overview Not available in current plan.. Upgrade
Regulations: IT security and EU laws Not available in current plan.. Upgrade
Regulations: Harmonized standards Not available in current plan.. Upgrade
Regulations: FDA Not available in current plan.. Upgrade
Analysis of vulnerabilities: Overview Not available in current plan.. Upgrade
Analysis of vulnerabilities: Objects Not available in current plan.. Upgrade
Analysis of vulnerabilities: Threats Not available in current plan.. Upgrade
Vulnerability Analysis Methods: Checklists Not available in current plan.. Upgrade
Vulnerability Analysis Methods: More checklists Not available in current plan.. Upgrade
Vulnerability Analysis Methods: Your own data Not available in current plan.. Upgrade
Vulnerability Analysis Methods: Input-output analysis Not available in current plan.. Upgrade
Penetration testing: Procedure Not available in current plan.. Upgrade
Penetration testing: Brute Force Not available in current plan.. Upgrade
Penetration testing: Reverse Engineering Not available in current plan.. Upgrade
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 usage 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.. Upgrade
Basics: Definition of terms Not available in current plan.. Upgrade
Basics: Regulations Not available in current plan.. Upgrade
Basics: Process Not available in current plan.. Upgrade
IEC 62366-1: Part 1 Not available in current plan.. Upgrade
IEC 62366-1: Part 2 - Subclause 5.1 Not available in current plan.. Upgrade
IEC 62366-1: Part 3 - Risk management Not available in current plan.. Upgrade
IEC 62366-1: Part 4 - UI specification Not available in current plan.. Upgrade
IEC 62366-1: Part 5 - UI Evaluation Not available in current plan.. Upgrade
IEC 62366-1: Part 6 - UOUP Not available in current plan.. Upgrade
IEC 62366-1: Part 7 - Documentation Not available in current plan.. Upgrade
Methods 1: Overview Not available in current plan.. Upgrade
Methods 2: Prototyping Not available in current plan.. Upgrade
Methods 3: Formative procedures Not available in current plan.. Upgrade
Methods 4: Usability tests Not available in current plan.. Upgrade
Context methods 1: Overview Not available in current plan.. Upgrade
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.. Upgrade
Intended Use and Intended Purpose Not available in current plan.. Upgrade
Classification Not available in current plan.. Upgrade
General Safety and Performance Requirements Not available in current plan.. Upgrade

Lessons

Name Course Watched Assessments

Templates

Letter
Name Latest update Comment EN
chevron Technical File (TF) open folder
TF-FOR-01-EN_Classification_MDD Not available in current plan.. Upgrade
TF-FOR-02-EN_MDD-Checklist Not available in current plan.. Upgrade
TF-FOR-03-EN_MDR_Checklist Not available in current plan.. Upgrade
TF-FOR-04-EN_Classification_MDR Not available in current plan.. Upgrade
TF-FOR-05-EN_IVDD-Checklist Not available in current plan.. Upgrade
TF-FOR-06-EN_IVDR-Checklist-Annex_I Not available in current plan.. Upgrade
TF-FOR-07-EN_IVDD-IVDR-Gap-Analysis (Excel) Not available in current plan.. Upgrade
TF-FOR-08-EN_IVDR-Checklist-Annex_II_III Not available in current plan.. Upgrade
TF-TPL-04-EN_Declaration-of-Conformity_MDD Not available in current plan.. Upgrade
TF-TPL-05-EN_Declaration-of-Conformity_MDR Not available in current plan.. Upgrade
TF-TPL-06-EN_System-Overview-IVD New Not available in current plan.. Upgrade
chevron Design Input (DI) open folder
DI-FOR-01-EN_Checklist-Stakeholder-Requirements Not available in current plan.. Upgrade
DI-FOR-03-EN_PHA-Checklist-ISO14971-2007 Not available in current plan.. Upgrade
DI-FOR-04-EN_PHA-Checklist-ISO14971-2012 Not available in current plan.. Upgrade
DI-FOR-05-EN_PHA-Checklist-TR24971-2019 Not available in current plan.. Upgrade
DI-TPL-01-EN_Indended-Use Not available in current plan.. Upgrade
DI-TPL-02-EN_Stakeholder-Requirements Not available in current plan.. Upgrade
DI-TPL-03-EN_Intended-Purpose-IVD Not available in current plan.. Upgrade
chevron Software File (SW) open folder
SW-FOR-01-EN_Software-Requirements-Specification-Checklist Not available in current plan.. Upgrade
SW-FOR-02-EN_Software-Architecture-Checklist Not available in current plan.. Upgrade
SW-FOR-05-EN_Software-Release Not available in current plan.. Upgrade
SW-FOR-06-EN_Code-Review-Checklist Not available in current plan.. Upgrade
SW-FOR08-EN_Template-Design-Review Not available in current plan.. Upgrade
SW-FOR-09-EN_Software-Safety-Classification Not available in current plan.. Upgrade
SW-FOR-10-EN_DiGA-Requirements-Checklist Not available in current plan.. Upgrade
SW-TPL-01-EN_SW-Development-Plan Not available in current plan.. Upgrade
SW-TPL-02-EN_Configuration-Management-Plan Not available in current plan.. Upgrade
SW-TPL-03-EN_Software-Requirements-Specification Not available in current plan.. Upgrade
SW-TPL-04-EN_Software-Architecture Not available in current plan.. Upgrade
SW-TPL-06-EN_System-Test-Protocol Not available in current plan.. Upgrade
SW-TPL-06-EN_System-Test-Protocol (Excel) Not available in current plan.. Upgrade
SW-TPL-07-EN_Machine-Learning Not available in current plan.. Upgrade
SW-TPL-08-EN_Software-Description Not available in current plan.. Upgrade
SW-TPL-09-EN_Cybersecurity-Documentation Not available in current plan.. Upgrade
SW-TPL-10-EN_Software-Full-Report Not available in current plan.. Upgrade
chevron Risk Management File (RM) open folder
RM-TPL-00-EN_Risikomanagement-File Not available in current plan.. Upgrade
RM-TPL-01-EN_Risk-Management-Plan Not available in current plan.. Upgrade
RM-TPL-02-EN_Risk-Management-Acceptance_Analysis_Evaluation (Excel) Not available in current plan.. Upgrade
RM-TPL-03-EN_Risk-Management-Report_compact Not available in current plan.. Upgrade
RM-TPL-04-EN_Risk-Management-Report_detailed Not available in current plan.. Upgrade
RM-FOR-01-EN_Checklist-Risk-Management-Plan Not available in current plan.. Upgrade
RM-FOR-02-EN_Checklist-Risk-Management-Analysis-and-Evaluation Not available in current plan.. Upgrade
RM-FOR-03-EN_Checklist-Risk-Management-Report Not available in current plan.. Upgrade
chevron Usability File / Human factors (HF) open folder
HF-TPL-01-EN_Usability-Engineering-File-UEF Not available in current plan.. Upgrade
HF-TPL-02-EN_Usability-Evaluation-Plan-UP Not available in current plan.. Upgrade
HF-TPL-03-EN_Usability-Evaluation-Protocol-UEP Not available in current plan.. Upgrade
HF-TPL-04-EN_Usability-Evaluation-Summary-Report-UESR Not available in current plan.. Upgrade
HF-TPL-05-EN_Usability-Engineering-File-UEF-UOUP Not available in current plan.. Upgrade
HF-TPL-15-EN_Checklist-IFU Not available in current plan.. Upgrade
HF-TPL-16-DE_Template-IFU-MDR Not available in current plan.. Upgrade
chevron Clinical Evaluation (CE) open folder
CE-TPL-01-EN_Clinical-Evaluation-Report Not available in current plan.. Upgrade
CE-TPL-02-EN_Clinical-Evaluation-Plan Not available in current plan.. Upgrade
CE-TPL-04-EN_SSCP Not available in current plan.. Upgrade
CE-TPL-05-EN_Literature-search-protocol (Excel) Not available in current plan.. Upgrade
CE-TPL-06-EN_Declaration-of-Interests Not available in current plan.. Upgrade
CE-TPL-12-EN_Literature-search-report Not available in current plan.. Upgrade
CE-TPL-13-EN_Demonstration-of-Equivalence (Excel) Not available in current plan.. Upgrade
CE-TPL-16-EN_Clinical-Evaluation-Plan_SW Not available in current plan.. Upgrade
CE-TPL-17-EN_Clinical-Evaluation-Report_SW Not available in current plan.. Upgrade
chevron Post-Market-Clinical-Follow-Up (CF) open folder
CF-TPL-01-EN_PMCF-Plan Not available in current plan.. Upgrade
CF-TPL-02-EN_PMCF-Report Not available in current plan.. Upgrade
chevron Development (PD) open folder
PD-TPL-01-EN_Design-and-development-plan-IVD Not available in current plan.. Upgrade
PD-TPL-02-EN-Product-Requirements-Specification-IVD Not available in current plan.. Upgrade
PD-TPL-03-DE_Product-Design-Specification-IVD Not available in current plan.. Upgrade
PD-LIS-01-EN_Checklist-Product-Development-IVD (Excel) Not available in current plan.. Upgrade
chevron IVD-Performance Evaluation (PE) open folder
PE-TPL-01-EN_Performance-Evaluation-Plan Not available in current plan.. Upgrade
PE-TPL-02-EN_Performance-Evaluation-Report Not available in current plan.. Upgrade
PE-TPL-03-EN_Literature-Search-Report Not available in current plan.. Upgrade
PE-TPL-04-EN_Scientific-Validity-Report Not available in current plan.. Upgrade
PE-TPL-05-EN_Analytical-Performance-Plan Not available in current plan.. Upgrade
PE-TPL-06-EN_Analytical-Performance-Report Not available in current plan.. Upgrade
PE-TPL-10-EN_PMPF-Plan Not available in current plan.. Upgrade
PE-TPL-11-EN_PMPF-Report Not available in current plan.. Upgrade
PE-FOR-01-EN_Literature-search-protocol (Excel) Not available in current plan.. Upgrade
Name Latest update Comment EN
chevron QM-Manual (QM) open folder
QM-QM-01-EN_QM-Manual Not available in current plan.. Upgrade
QM-QM-02-EN_Quality-Policy Not available in current plan.. Upgrade
QM-QM-03-EN_Quality-Objectives Not available in current plan.. Upgrade
chevron Management Review & Audit (MR / IA / UA) open folder
MR-SOP-01-EN_Management-Review Not available in current plan.. Upgrade
MR-SOP-02-EN_Data-Analysis Not available in current plan.. Upgrade
MR-TPL-01-EN_Management-Review-Report Not available in current plan.. Upgrade
MR-FOR-01-EN_Data-Analysis Not available in current plan.. Upgrade
IA-SOP-01-EN_Internal-Audit Not available in current plan.. Upgrade
IA-LIS-01-EN_Action-Plan (Excel)  Not available in current plan.. Upgrade
IA-TPL-01-EN_Audit-Program Not available in current plan.. Upgrade
IA-TPL-02-EN_Audit-Plan Not available in current plan.. Upgrade
IA-TPL-03-EN_Audit-Report Not available in current plan.. Upgrade
UA-SOP-01-EN_Unannounced-Audits Not available in current plan.. Upgrade
chevron Corrective and preventive actions (CA) open folder
CA-SOP-01-EN_Corrective-and-Preventive-Actions Not available in current plan.. Upgrade
CA-FOR-01-EN_CAPA-Form Not available in current plan.. Upgrade
CA-LIS-01-EN_CAPA-List (Excel)  Not available in current plan.. Upgrade
chevron Document & Record Control (DC) open folder
DC-SOP-01-EN_Control-of-Documents-and-Records Not available in current plan.. Upgrade
DC-LIS-01-EN_SOP-Checklist Not available in current plan.. Upgrade
DC-LIS-02-EN_Processes-ISO-13485 Not available in current plan.. Upgrade
DC-LIS-03-EN_Glossary Not available in current plan.. Upgrade
DC-LIS-04-EN_Document-List (Excel)  Not available in current plan.. Upgrade
DC-FOR-01-EN_Document-Review New Not available in current plan.. Upgrade
DC-TPL-01-EN_SOP-Template Not available in current plan.. Upgrade
DC-TPL-02-EN_List-Template (Excel)  Not available in current plan.. Upgrade
chevron Human Resources & Training (HR) open folder
HR-SOP-01-EN_Recruiting-and-Training Not available in current plan.. Upgrade
HR-TPL-01-EN-Job-Description Not available in current plan.. Upgrade
HR-FOR-01-EN_Training-Record Not available in current plan.. Upgrade
HR-FOR-02-EN_Effectiveness-Check Not available in current plan.. Upgrade
HR-FOR-03-EN_Privacy-Statement Not available in current plan.. Upgrade
HR-FOR-04-EN-Training_Plan Not available in current plan.. Upgrade
chevron Infrastructure (IS) open folder
IS-SOP-01-EN_Computer-System-Validation Not available in current plan.. Upgrade
IS-SOP-02-EN_Measuring-Equipment Not available in current plan.. Upgrade
IS-LIS-01-EN_List-of-Computerized-Systems Not available in current plan.. Upgrade
IS-LIS-01-EN_List-of-Computerized-Systems (Excel) Not available in current plan.. Upgrade
IS-LIS-02-EN_List-of-measuring-instruments Not available in current plan.. Upgrade
IS-LIS-02-EN_List-of-measuring-instruments (Excel) Not available in current plan.. Upgrade
IS-TPL-01-EN_Evaluation-Computerized-Systems Not available in current plan.. Upgrade
IS-TPL-02-EN-Validation-Plan Not available in current plan.. Upgrade
IS-TPL-03-EN_Test-protocol Not available in current plan.. Upgrade
IS-TPL-03-EN_Test-protocol (Excel) Not available in current plan.. Upgrade
IS-TPL-04-EN_Validation-Report Not available in current plan.. Upgrade
chevron Development and Product Management open folder
CE-SOP-01-EN_Clinical-Evaluation Not available in current plan.. Upgrade
PD-SOP-01-EN_Problem-Resolution Not available in current plan.. Upgrade
PD-SOP-02-EN_Product-Development-IVD-Assay-Instrument Not available in current plan.. Upgrade
PD-SOP-03-EN_Product-Development Not available in current plan.. Upgrade
RM-SOP-01-EN_Risk-Management Not available in current plan.. Upgrade
PE-SOP-01-EN_Performance-Evaluation Not available in current plan.. Upgrade
HF-SOP-01-EN_Usability-Engineering-Process Not available in current plan.. Upgrade
SW-SOP-01-EN_Software-Development Not available in current plan.. Upgrade
CF-SOP-01-EN_Post-Market-Clinical-Follow-Up Not available in current plan.. Upgrade
chevron Supplier Management & Procurement (SA, PS) open folder
SA-SOP-01-EN_Tendering-and-Sales Not available in current plan.. Upgrade
SA-TPL-01-EN_Non-Disclosure-Agreement Not available in current plan.. Upgrade
PS-SOP-01-EN_Purchase Not available in current plan.. Upgrade
PS-SOP-02-EN_Supplier-Selection-and-Evaluation Not available in current plan.. Upgrade
PS-SOP-03-EN_Supplier-Surveillance Not available in current plan.. Upgrade
PS-LIS-01-EN_Supplier-List (Excel) Not available in current plan.. Upgrade
PS-FOR-01-EN_Supplier-Evaluation Not available in current plan.. Upgrade
PS-FOR-02-EN_Checklist-Incoming-Goods-Distributors Not available in current plan.. Upgrade
PS-FOR-03-EN_Checklist-Incoming-Goods-Importers Not available in current plan.. Upgrade
PS-TPL-01-EN_QAA Not available in current plan.. Upgrade
chevron Production & Service Delivery (SU, PR, LA) open folder
SU-SOP-01-EN_Support Not available in current plan.. Upgrade
PR-SOP-02-EN_Non-Conforming-Products Not available in current plan.. Upgrade
LA-LIS-01-EN_Device-identifiers (Excel) Not available in current plan.. Upgrade
LA-SOP-02-EN_UDI-Labeling-Tracking Not available in current plan.. Upgrade
chevron Change Management (CC) open folder
CC-SOP-01-EN_Change-Management Not available in current plan.. Upgrade
CC-FOR-01-EN_Change-Request Not available in current plan.. Upgrade
CC-LIS-01-EN_Change-List (Excel) Not available in current plan.. Upgrade
chevron Post-Market Surveillance, Feedback (CH, PM) open folder
CH-SOP-01-EN_Complaint-Handling Not available in current plan.. Upgrade
PM-SOP-01-EN_Post-Market-Surveillance Not available in current plan.. Upgrade
PM-SOP-02-EN_Post-Market-Surveillance-IVD Not available in current plan.. Upgrade
PM-TPL-01-EN_PMS-Report Not available in current plan.. Upgrade
PM-TPL-05-EN_PMS-Report-IVD Not available in current plan.. Upgrade
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PM-TPL-06-EN_Periodic-Safety-Update-Report-IVD Not available in current plan.. Upgrade
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PM-TPL-04-EN_Market-Analysis (Excel)  Not available in current plan.. Upgrade
chevron Authorities and Regulatory Affairs (TF, RU, VI) open folder
TF-SOP-01-EN_Product-Release-EU-MDD Not available in current plan.. Upgrade
TF-SOP-02-EN_Product-Release-FDA Not available in current plan.. Upgrade
TF-SOP-03-EN_Product-Release-EU-MDR Not available in current plan.. Upgrade
TF-SOP-04-EN_Product-Release-EU-IVDR Not available in current plan.. Upgrade
VI-SOP-01-EN_Incident-Reporting-EU_MDD Not available in current plan.. Upgrade
VI-SOP-02-EN_Incident-Reporting-USA Not available in current plan.. Upgrade
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VI-FOR-01-EN_Incident-Reporting_EU_MDD Not available in current plan.. Upgrade
VI-FOR-02-EN_Incident-Reporting_USA Not available in current plan.. Upgrade
VI-FOR-03-EN_Incident-Reporting_EU_MDR Not available in current plan.. Upgrade
RU-SOP-01-EN_Regulatory-Update Not available in current plan.. Upgrade
RU-LIS-01-EN_List-of-regulations-to-be-monitored Not available in current plan.. Upgrade