Conference: November 8 & 9, 2017
Roundtable session: November 8 & 9, 2017
Location: Newport Beach Marriott Bayview, 500 Bayview Circle Newport Beach, California 92660 USA
Price: Normal: $ 1500.-
Want to learn more about the following and have interactive discussions:
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 conference 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.
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
• 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
There is the opportunity to discuss one-to-one with a Notified Body your main issues/questions towards MDR certification. Please indicate your preference for a slot date, it will be first come, first served (1 slot per company). When your preference is booked, we will contact you to find an alternative.
The roundtable sessions also provide opportunities to discuss options how Qserve can help you with the MDR implementation. Our US team is available to elaborate on the options. A perfect way to learn more from our MDR experts.
Qserve MDR expert Speakers:
Gert Bos, Executive Director and Partner at Qserve
Keith Morel, VP Regulatory Affairs at Qserve
Dr. ir Gert Bos, EU-MDR specialist and leading Qserve’s efforts around the EU-MDR will moderate the sessions. He will bring the audience up to speed with the latest developments.
Mindy McCann, VP Regulatory Affairs at Qserve
Mindy comes to Qserve with more than 15 years of experience in medical device international Regulatory Affairs. During that time, Mindy worked for a private medical device manufacturer and two notified Bodies, providing expertise in European, Canadian and Australian medical device regulations and medical device quality management systems.
Prior to Qserve, Keith was at one of the European Notified Bodies (KEMA, now DEKRA) for 9 years, where he became expert in European regulatory, quality and clinical requirements having conducted over 200 design dossier/technical file reviews and over 100 audits of all types.
Notified Body Expert Speaker:
Dr.-Ing. Royth v. Hahn, VP Medical and Health Services NAFTA Region, Global Director Functional Safety, Software & Innovation at TÜV SÜD.
Royth v. Hahn leads the TÜV SÜD Business Unit “Medical and Health Services” in the NAFTA region and is responsible for functional safety and software for medical devices globally. He also leads the “investor’s program” with services of technical and regulatory due diligence.He started his career at the University of Bonn and a MedTech spin off/start up. He was head of a test laboratory and interim professor at the University of Applied Sciences in Koblenz. Royth worked within TÜV SÜD as Senior Product Specialist for ultrasound devices and lead auditor active medical devices and software. He is member of several national and international standardization committees.
- 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
08.45 Welcome opening the door
09.00 Medical Device Regulation and the New Approach
09.30 Legal and operational structure
Exercise: downstream supply chain
Exercise upstream Supply chain
10.30 Structure and purpose of MDR EU 2017/745
10.45 General Contents of MDR EU 2017/745
11.45 New conformity assessment routes
Exercise: Conformity assessment
13.30 Essential Principles
14.30 Role and importance of Risk Management
17.00 Wrap up and final questions
17.30 18.30 round table session with TUV Sud
9.00 Active Post Market Surveillance & PMCF
Exercise: Periodic Update reporting
10.00 Revisions to Vigilance and reporting to the Competent Authority
11.00 Clinical Evaluation & Clinical Investigation
Questions & Answers
13.00 8 steps implementation program
Exercise Impact assessment
Exercise Transition plan
16.00 Evaluation of the Course and Closing
17.00 – 18.00 round table session with TUV Sud
>>>End of program<<<