Online Webinar 2019 - Developing premarket approval packages for innovations which are more effective in reducing potential adverse events; MAUDES; and or recalls particularly FDA class recalls

Overview
Device makers face a market upheaval in the EU. A new set of rules — the Medical Device Regulation (MDR) — will soon supplant the longstanding Medical Device Directive, forever changing how you sell medical devices in EU nations.
The number of rules will increase from 18 to 22, dramatically impacting what quality and regulatory specialists do every day. Changes in classification rules will require manufacturers to confirm and update documentation to reflect the changes. And this just scratches the surface.
Session Highlights
Join us for 90 minutes of total immersion into the forthcoming changes. You’ll discover:
Documentation confirmation and updating: Specific changes you’ll be required to make
New separate software rules and what they say
How the aforementioned rules increase, from 18 to 22, could affect your job
Stricter requirements for implantable devices: The impact on quality and compliance
The consequences of delay: Sanctions you could face, markets you could lose
And much more!
Once the MDR takes effect, you’ll have three years to adapt to the changes. Don’t kid yourself: The time to start preparing is right now
Who Will Benefit
This webinar aids everyone with responsibility for medical device regulatory lifecycles, quality management systems design and implementation, or product design and development, including specific responsibilities such as:
QA/QC
Manufacturing/GMP
Designers/engineers
Regulatory affairs/compliance
Business development
Marketing/sales
Legal counsel
Consultants
Speaker
Edwin Waldbusser retired from industry after 20 years in management of development of medical device products and development of company Quality Systems. Products included IVD devices, kidney dialysis systems and inhalation devices.
His QS experience includes design control, risk analysis, CAPA, software validation, supplier qualification/control and manufacturing/non-conforming product programs.
Ed has a B.S. Mechanical Engineering from NYU and a M.B.A from Drexel University. He is certified by Lloyds of London as an ISO 9000 Lead Auditor and is a member of the Thomson Reuters Expert Witness network. He has 5 issued patents.