Live Webinar Intro to the new EU Medical Device Regulation
01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 60 Minute
Webinar Includes : All the training handouts , Certificate by the Speaker ,Q/A and 60 Min Live Webinar
"Hear By Charles H Paul has been a regulatory and management consultant and an Instructional Technologist for 30 years"
Current state of the MDDs and MDR
At the completion of this webinar, participants will be able to discuss the changes to the MDR as compared to the current Medical Device Directives in terms of notified bodies, clinical evidence, pre-market, transparency and traceability, and governance and oversight. Also to be discussed, will be the strategy that will be employed to transition to the new MDR to ease the burden upon compliance. There will also be a general navigation review of the regulation with a discussion of the contents of each relevant section. This webinar will detail the changes and discuss their implications upon medical device manufacturers. This is essential for all of those tasked with designing, developing, manufacturing, servicing, and marketing medical devices.
Why should you attend :
The official texts of the new Medical Device Regulation and the new InVitro Diagnostic Regulation are currently being phased in within the EU. The current MDR stands at 350 pages and is a complex array of regulations written in the normal legalese. There are many changes that anyone designing, manufacturing, and/or marketing medical devices into the EU needs to be aware of when compared to the original Medical Device Directives.
• Current state of the MDDs and MDR
• Transition period
• Key changes – notified bodies, clinical evidence, pre-market, transparency and traceability, governance and oversight
• Regulation overview
• Changes to rules
• Conformity assessment procedures
• Notified body designation
• How this new regulation will impact US companies
Who will Benefit
This webinar will benefit everyone who is involved in the design and development of medical devices to include:
• Audit and Compliance Personnel / Risk Managers
• Research and Development Engineers
• Vice-Presidents, Directors, and Managers of medical device design functions
• Medical device marketing personnel
Industries who can attend
This 60-minute online course is intended for professionals in the Medical Device, Biotechnology,Pharmaceutical Industry. Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel.