MDR Technical Documentation
690 €
Learn how to build compliant and up-to-date technical documentation according to MDR requirements!
This e-learning course will help you understand MDR expectations and structure your technical documentation in a systematic way, with special focus on device safety, performance, and traceability.
Information
The training material is available interactively through an e-learning platform anytime and anywhere, allowing you to learn entirely at your own pace.
Your acquired knowledge will be assessed through online quizzes, and upon successful completion, you will receive a certificate confirming completion of the training.
✓ Author: Andrea Baisánszki (NoBoMed Zrt.) and György Ferenc Balázs (EMKI-Cert)
✓ Access to the course material for 3 months from the date of purchase
✓ 60-page training material presenting the fundamentals of technical documentation
✓ Online tests to reinforce your knowledge
✓ Certificate documenting completed course modules and achieved results
Do you have questions about the course content? Simply send us an email at info@noboversum.hu and we will forward your question to the expert for a professional response.
Topics
- Precise technical description of the device, including variants and accessories
- Information supplied by the manufacturer
- Information related to design and manufacturing
- General Safety and Performance Requirements (GSPR)
- Benefit-risk analysis and risk management
- Product verification and validation
- Post-Market Surveillance Plan (PMSP)
- Periodic Safety Update Report (PSUR)
- Post-Market Surveillance Report (PMSR)
- Technical documentation generated during design activities
- Elements originating from quality management system processes
- Manufacturing and inspection documentation
- Integration of risk evaluation, GSPR, and clinical evaluation
- Demonstration of compliance with the definition of a “medical device”
- Justification and practical implementation of classification, including classification guidance
- Periodic Safety Update Report (PSUR)
- Summary of Safety and Clinical Performance (SSCP)
- New MDR requirements related to technical documentation
- More detailed and structured documentation expectations
- Requirements for maintaining documentation and continuously updating clinical evaluation
- Traceability (UDI) and post-market follow-up
- Key points of the Team-NB guidance document
(Best Practice Guidance for the Submission of Technical Documentation under Annex II and III of MDR) - Common deficiencies in MDR technical documentation
