Thursday, 30 August 2018
5:30-8:00 pm EDT
Hampton Inn Warsaw
115 Robmar Drive
Warsaw, IN 46582
+1 574 268 2600
On 5 May 2017, the European Commission adopted the new Medical Device Regulation (MDR) 2017/745. There is a three-year transition period, ending in May 2020, after which the regulation will take effect. Device manufacturers have the duration of this transition period to update their technical documents and processes to meet the standards.
Come engage with professionals from your local regulatory community for an interactive presentation on how to prepare for the implementation. The new regulation introduces more stringent clinical and post-market surveillance requirements for medical device manufacturers, regardless of risk classification. Come join us and learn strategies that can help your orthopedic device company navigate the higher level of scrutiny.
This session will include:
Overview of MDR changes with Jia Li, group leader, auditing NAM 2, MHS:
- When legacy products need to be evaluated
- Acquisition of companies with existing products on the market
- Difference between the EU and FDA requirements concerning technical documentation
- Difference between Notified Bodies
- Transferring challenges of products from one Notified Body to another
- Changes in the regulation
- Areas of higher expectations
Overview of clinical requirements with Dr. Mattias Fink, clinical reviewer MHS:
- Key differences between the MDR and the MDD regarding clinical evaluation
- Data from clinical investigations vs. data from literature review
- Relevant changes regarding the demonstration of equivalence
- The additional scrutiny and requirements in the pre and post-market phase
- MEDDEV 2.7/1, Rev. 4 guidance document toward the transition from the MDD to the MDR
Overview of new Instrument Reprocessing Instructions and Requirements for EU:
- EN ISO 17664 VS FDA What’s new and Different?
- What Hidden Problems with Instruments Files – How Bad is the problem?
- Collateral Damage
This event is coordinated by the RAPS Indiana chapter and is intended to encourage knowledge sharing and community development. Dinner will be available for all attendees and RAC holders may claim two RAC recertification credits.
Matthias Fink, MD, clinical reviewer, Clinical Centre of Excellence at TÜV SÜD
Jia Li, MSE, MBA, team manager and lead auditor, TÜV SÜD
RAPS Members: $35