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News and Highlights

Courses

Regulatory Basics
0%
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
International Authorization
0%
Description

 

A lot of medical device manufacturers see the international authorization of their device as a potential hazard: the opportunities offered by new markets are offset by hard-to-calculate risks as well as the time and costs required to obtain these authorizations.

Manufacturers will be better in a better position to manage these risks if they complete these courses. 

 

Sprints
An introduction to the legal system according to MDR
0%
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
MDSAP
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Description

 

The Medical Device Single Audit Program (MDSAP) was initiated to satisfy a wish of many medical device manufacturers: To replace the various audits and inspections by authorities with one standardized audit.

 

 

Participating in the MDSAP shall suffice for verifying effectiveness and conformity of QM systems (e.g. with ISO 13485 or 21 CFR part 820).

In this article, you will learn if this wish has really come true and at what price.

 

 

Sprints
Name Assessments
MDSAP: Medical Device Single Audit Program Not available in current plan.. Book a free demo
Digital Health Applications DiGA
0%
Description

 

On April 17, 2020, the German Federal Ministry of Health (Bundesministerium für Gesundheit) presented the preliminary draft of the Digital Health Applications Ordinance, the DiGAV for short. The DiGAV establishes the requirements for the reimbursement of digital health applications (DiGA) by health insurance companies.

Find out what requirements the ordinance establishes for manufacturers so that you can decide whether an application is worthwhile and whether the costs involved are proportional to the expected economic benefits.

 

Sprints
Health Care Facilities
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Description

 

The MDR and IVDR contain hundreds of requirements for the manufacturers of medical devices. But these requirements also affect the so-called health care institutions, such as operators of clinics or hospitals.

The understanding of these requirements helps the operators to avoid regulatory problems, and the manufacturers to act more successfully on the market. Because regulatory requirements for the operators also affect the manufacturers.

 

Sprints
FDA-approval
0%
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
MDR for auditors
0%
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
Regulatory Update
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Description

 

Medical device manufacturers are required to carry out a regular “regulatory update.” Because as strange as it sounds, regulatory requirements oblige manufacturers to continuously monitor and evaluate changes to regulatory requirements and take any necessary measures.

Keeping track of thousands of regulatory requirements is a challenge. Manufacturers should have a clear understanding of the typical mistakes that they should avoid at all costs in order to, firstly, have certainty during audits and, secondly, to save themselves unnecessary time and effort on their “regulatory update.”

 

Sprints
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.

 

 

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
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
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 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.

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
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
Instructions for Use and Labeling
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Description

 

In the EU, with few exceptions, IFU must be provided in all languages of the member countries where the product is marketed. Numerous standards impose further specific requirements on IFU. Furthermore, the MDR as well as the IVDR require the provision of product-specific training, should this be necessary for the safe use of the product.

 

Sprints
Post-Market Survaillance
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Description

 

Before bringing medical devices to market, manufacturers must minimize their risks and ensure patients' safety. This is monitored by authorities and notified bodies during authorization and conformity assessment procedure.

However, some risks manifest over time, when medical devices are used daily by practitioners.

Post-market surveillance aims at

  • systematically identifying these risks when occurring during practical usage
  • monitoring the products' performance afield
  • detecting product faults and safety issues left undetected
  • constantly updating the benefit-risk assessment 
  • quickly initiating necessary measures such as recalls

 

Sprints
Quality Management (ISO 13485)
0%
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
Masuring 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
Computer System Validation
0%
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
0%
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
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.

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

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
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
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
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