September 20, 2018 - September 21, 2018
Date: 20 & 21 September 2018
Location: Amsterdam Area
Language: Presentations will be in English
Subscription for: Regular € 1250.-
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The medical device regulation for EU is renewed. The MDR implementation needs to be completed by Q1 2020, all your devices need to have new certificates. This time the change in regulation is significant, you better be prepared.
Qserve is the largest regulatory consultancy company in EU, having also offices in the US. For the last 2 years, Qserve is busy helping manufacturers to become compliant with the MDR.
Now since the MDR is officially published there is a large number of companies that have read the MDR, however, continue to struggle on 2 levels:
1. How to interpret the requirements. What does it mean for my company?
2 Implementation of the changed requirements. How does my company close the GAP(s)?
Our 2-day training will cover both aspects in a practical manner, combining workshops. Specific topics will be addressed, and workshops will offer opportunities for in-depth discussions.
Want to learn more about the following and have interactive discussions:
Critical impacts of the EU MDR, and how your company will be affected:
• Understand the Medical Device Regulations approach in Europe
• Understand the structure and purpose of Medical Device Regulation
• Explain the use of Essential principles including the use of (harmonized) standards and Common Specifications
• Apply the new Classification Criteria and Implementation rules
• Identify the new conformity assessment routes
• Identify revised Technical Documentation requirements
• Importance and role of Clinical Data
• Identify the importance and contents of Post Market Surveillance
Medical Device Regulation and the New Approach
Legal and operational structure
Structure and purpose of MDR EU 2017/745
General Contents of MDR EU 2017/745
New conformity assessment routes
Role and importance of Risk Management
Active Post Market Surveillance & PMCF
Revisions to Vigilance and reporting to the Competent Authority
Clinical Evaluation & Clinical Investigation
Questions & Answers
Evaluation of the Course and Closing