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Courses

Regulatory Basics: Is your product a medical device?
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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.

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 - Qualification 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
An introduction to the legal system according to MDR
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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
The intended purpose
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Description

 

Your mission, if you choose to accept it, is to become a recognized expert in intended purposes. After this course, you'll write intended purposes that are as precise as they are streamlined, and that you can be assured will stand up in reviews and approvals.

You will be well aware how critical these intended purposes are to the qualification, classification and approval of your products. But you will also know all the regulatory requirements and how to write these documents quickly and effortlessly.

However, your mission goes further: At the end of this course, you will have a perfect and approved intended purpose for one of your products. An intended purpose that provides a solid foundation for your product's development and post-market surveillance. An intended purpose that will be used as a model in your company in the future.

 

Sprints
Name Assessments
Your mission Not available in current plan. . Book a free demo
Preparation Not available in current plan. . Book a free demo
Fundamental principles Not available in current plan. . Book a free demo
Regulatory requirements (part 1) Not available in current plan. . Book a free demo
Checking intended purposes (part 1) Not available in current plan. . Book a free demo
Working with templates Not available in current plan. . Book a free demo
Intended use Not available in current plan. . Book a free demo
IEC 62366-1 and context of use Not available in current plan. . Book a free demo
Checking an intended purpose (part 2) Not available in current plan. . Book a free demo
Intended purpose for a product that is not your own Not available in current plan. . Book a free demo
Requirements of ISO 14971 Not available in current plan. . Book a free demo
Intended purpose of your own product Not available in current plan. . Book a free demo
Conflict prevention and resolution Not available in current plan. . Book a free demo
Quality Management (ISO 13485)
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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: roles and responsibilities
Roles and responsibilities 01: Fundamentals Not available in current plan. . Book a free demo
Roles and responsibilities 02: Regulations Not available in current plan. . Book a free demo
Roles and Responsibilities 3: QM Representative 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
IEC 62366-1:2015 Not available in current plan. . Book a free demo
IEC 60601-1 Not available in current plan. . Book a free demo
IEC 62304 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
chevron right QM-System: Sales
Sales 1: Intro Not available in current plan. . Book a free demo
Sales 2: Risks Not available in current plan. . Book a free demo
Sales 3: Actions and SOPs Not available in current plan. . Book a free demo
Sales 4: Regulatory requirements Not available in current plan. . Book a free demo
chevron right QM system: Infrastructure
Infrastructure: Part 1 Introduction Not available in current plan. . Book a free demo
Infrastructure: Part 2 Requirements Not available in current plan. . Book a free demo
Infrastructure: Part 3 Maintenance activities and documentation Not available in current plan. . Book a free demo
chevron right QM system: Measuring equipment
Measuring equipment 1: Introduction Not available in current plan. . Book a free demo
Measuring equipment 2: Regulatory requirements 13485 (overview) Not available in current plan. . Book a free demo
Measuring equipment 3: Regulatory requirements 13485 (7.6 - Part 2 - Measuring equipment) Not available in current plan. . Book a free demo
Measuring equipment 4: Regulatory requirements 13485 (7.6. - Part 3 - Software) Not available in current plan. . Book a free demo
Measuring equipment 5: Regulatory requirements 13485 (procedure instruction) Not available in current plan. . Book a free demo
The person responsible for regulatory compliance
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Description

 

Regardless of the types of medical device you are marketing, regardless of their class and regardless of whether you need a notified body for this or not: you need to establish a person responsible. Unfortunately, EU regulations do not grant you a transition period for this. 

Since you need to register this responsible person, authorities can easily check whether you are meeting the regulatory requirements.

This course covers:

  • Role of the Person Responsible for Regulatory Compliance (PRRC) as per MDR/IVDR Article 15 and relevant regulation
  • Who needs a PRRC and the difference between having one and having access
  • Qualification requirements for a PRRC
  • PRRC's responsibilities defined by MDR/IVDR
  • PRRC's involvement in product assessment, Technical Documentation, and Post-Market Surveillance
  • PRRC's role in vigilance, reporting, and testing
  • Finding suitable PRRC candidates and integrating the role in your company (insurance, organization, contract, division of responsibility, EUDAMED registration)

 

Lessons
Name Watched Assessments
Introduction Not available in current plan. . Book a free demo
Regulations Not available in current plan. . Book a free demo
Obligation to have a PRRC Not available in current plan. . Book a free demo
Qualification Not available in current plan. . Book a free demo
Responsibilities (overview) Not available in current plan. . Book a free demo
Product release Not available in current plan. . Book a free demo
Technical Documentation Not available in current plan. . Book a free demo
Post Market Surveillance Not available in current plan. . Book a free demo
Vigilance, Reporting 1 Not available in current plan. . Book a free demo
Vigilance, Reporting 2 Not available in current plan. . Book a free demo
Investigational devices Not available in current plan. . Book a free demo
Finding PRRC Not available in current plan. . Book a free demo
Risk management according to ISO 14971
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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 Unique Device Identification (UDI)
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Description

 

Medical devices must have a UDI, a unique device identifier, in order to be tracked in the field.


This course will provide you with the basics you need to equip your products with a correct UDI and to meet the regulatory requirements.

 

Expect the following topics in this course:

  • Basics needed to provide products with a correct UDI
  • Basics needed to meet the regulatory requirements of MDR and IVDR regarding UDI
  • Differences in the requirements for the UDI system from MDR and IVDR
  • Know what the Basic UDI-DI is and where it needs to be used
  • Knowledge of how the UDI is applied for, allocated and assigned by the issuing entities
  • Knowledge about the UDI carriers as well as how to apply these carriers
  • Knowledge of the special cases of the UDI for software, implants, systems and procedure packs and configurable devices 
  • Knowledge of when a new UDI must be assigned
  • Knowledge of the role of the UDI in EUDAMED
  • Essential differences between the European and the American (FDA) UDI system
  • Knowledge of the transition periods granted by the MDR with regard to the UDI

 

Lessons
Name Watched Assessments
Introduction Not available in current plan. . Book a free demo
Basics Not available in current plan. . Book a free demo
Product categories Not available in current plan. . Book a free demo
Basic UDI-DI Not available in current plan. . Book a free demo
Regulatory requirements Not available in current plan. . Book a free demo
Allocation and assignment of UDI Not available in current plan. . Book a free demo
GS1 Not available in current plan. . Book a free demo
HIBCC Not available in current plan. . Book a free demo
UDI carrier Not available in current plan. . Book a free demo
Application Not available in current plan. . Book a free demo
Implants Not available in current plan. . Book a free demo
Systems and procedure packs Not available in current plan. . Book a free demo
IVDR Not available in current plan. . Book a free demo
Configurable products Not available in current plan. . Book a free demo
UDI and Software Not available in current plan. . Book a free demo
New UDI Not available in current plan. . Book a free demo
EUDAMED Not available in current plan. . Book a free demo
FDA differences Not available in current plan. . Book a free demo
Transition periods Not available in current plan. . Book a free demo
The software development according to IEC 62304
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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.

Depending on your membership, templates with detailed instructions are available for you to fill out. This speeds 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
Usability engineering according to IEC 62366-1
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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
Clinical evaluation according to MEDDEV 2.7/1 Rev 4
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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
Regulations: MEDDEV 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
MDR for auditors
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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
Computer System Validation
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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
Biocompatability
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Description

 

Reading course:

Regulations such as the MDR require proof of biocompatibility for all materials that come into direct or indirect contact with patients or users. 

Learn in this reading course:

  • which standards are applicable for your products (EN ISO 18562 vs ISO 10993)
  • what needs to be done to prove biocompatibility
  • what you need to consider when your products need to be reprocessed and
  • what to consider when choosing the right laboratory for cytotoxicity testing

 

Sprints
IT security for medical devices
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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.

 

The following topics are part of this course:

  • the protection goals in IT security
  • regulatory requirements for IT security of medical devices in the EU and the USA
  • methods to identify vulnerabilities in systems, in products or components
  • basic knowledge of penetration testing (procedure and methods)

 

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
FDA-approval
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Description

 

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.

This course is currently under construction. If you have any questions, please feel free to email us at: elearning@johner-institut.de.

 

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

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-FOR-09-EN_Classification-IVDR (Excel) 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
DI-TPL-04-EN-Formulation-Stencil_IP_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-FOR-08-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
SW-TPL-11-EN_SW-Verification-Plan Not available in current plan. . Book a free demo
SW-TPL-12-EN_SW-Verification-Report Not available in current plan. . Book a free demo
SW-TPL-13-EN_Validation-Plan Not available in current plan. . Book a free demo
SW-TPL-14-EN_Validation-Report Not available in current plan. . Book a free demo
SW-LIS-01-EN-List-of-documents_SW-file Not available in current plan. . Book a free demo
chevron Risk Management File (RM) closed folder
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