Online Training
Technical documentation following Annex II and III of MDR and IVDR
Important aspects to avoid pitfalls
Available Dates & Times
● coming soon
Description
This training outlines the requirements for technical documentation complying with Annex II of MDR and IVDR. It focuses specifically on the general safety and performance requirements (GSPR) and connects the general requirements in Annex I with a documented risk management system follow-ing EN ISO 14971.
It also explains what needs to be considered when completing the GSPR check-list and how to reference standards.
Annex III of MDR and IVDR defines the content related to the post-market surveillance system (PMS) which provides input to the technical documentation and the risk management system. The training shows what information needs to become part of the technical documentation and its up-date.
Net price
€ 330.-
- Access to online training
- Presentation slides as handout
- Certificate of attendance
Overview of covered topics
- Technical documentation as required in Annex II
- General safety and performance requirements in Annex I with focus on risk management
- Technical documentation on post-market surveillance following Annex III
Purpose of the training
Participants will be enabled to understand,
- how to draw up a technical documentation complying with Annex II and III
- how to deal with the general safety and performance requirements (GSPR) in Annex I
- how the GSPR 1-8 interrelate with a risk management system according EN ISO 14971
Who should attend
- Manufacturer
- Regulatory Affairs Manager
- PMS-Manager
- Personal, directly or indirectly involved in the creation of a technical documentation
Basic knowledge required
- Basic knowledge in EU-MDR
- Basics Risk Management
- Basics in Post Marketing Surveillance Activities
Presenting expert
Dr. Susanna Kerschl
Senior Consultant
AKRA TEAM GmbH
Dr. Anna Spehl
Senior Consultant
AKRA TEAM GmbH
Norchéne BenMadhi
Consultant
AKRA TEAM GmbH
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