Date: 19 & 20 February 2018
Location: Amsterdam, Novotel Amsterdam Schiphol Airport, Taurusavenue 12, 2132 LS Hoofddorp
Language: Presentations will be in English
Subscription for: Regular € 750.-
Early Bird € 675.- (until the 24th of December 2017)
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 and a speaker from a Notified body. 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
- Essential Principles
- 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