RAPS pre-approved webinar on "Selling Medical Devices in the EU-Medical Device Directive, CE & FDA" from GlobalCompliancePanel
GlobalCompliancePanel, a leading regulatory and compliance continuing education training provider, will organize a RAPS pre-approved webinar on the topic, "Selling Medical Devices in the EU-Medical Device Directive, CE & FDA" on October 4.John Chapman, Regulatory Affairs professional, will be the speaker of this 60-minute webinar.
- Wilmington, NC (1888PressRelease) October 04, 2012 - For medical devices to be sold into the EU, manufacturers have to comply with the regulatory guidelines set out by the EU. These are somewhat of the same nature as FDA regulatory requirements. A product that enters the EU market has to have the 'CE' sign on it, meaning that it is certified as being fit and safe to be sold in that EU.
Why is entering the EU market important for American medical device companies? It is because the EU, consisting of 29 member states, has more population than the combined population of NAFTA countries consisting of the US, Mexico and Canada. That is why it is essential for medical device companies to know about regulations in the EU.
This webinar will offer an explanation, in simple and understandable terms, the various routes to CE marking of medical devices. It will have a special focus on the Medical Device Directive, MDD 93/42/EEC.
This webinar covers the following areas:
o New approach directives and background
o IVD, MDD and Active Implantable Directive
o Competent Authorities and Notified Bodies
o Medical Device Directive
o Device classification
o Routes to CE marking under various MDD annexes
o Technical files
o Essential requirements checklists
o ISO 13485:2003 Quality System Certification
When:October 4, 10:00 AM PDT | 01:00 PM EDT
By whom:
John Chapman, BS, MBA, RAC has been in the medical device regulatory industry for over 30 years, over 10 of which have been spent with the European Union's medical device directive, 93/42/EEC. Leading two device companies to ISO quality system certification and CE marking is one of the highpoints of his highly successful career.
In the course of performing regulatory due diligence on over a dozen acquisitions in the past 12 years, John has been exposed to numerous Quality Systems, including consent decrees. This work has also acquainted him with many notified bodies.
He earned his Regulatory Affairs Certification (RAC) in 1998 and was a contributing author to 2004 Fundamentals of EU Regulatory Affairs, RAPS, 2004. He co-founded a local RAPS chapter and has been a speaker at these meetings and the annual RAPS conference.
For whom:
The webinar will benefit
o Quality & Regulatory Professionals
o Manufacturing & Design Engineers
o Marketing Product Managers
Duration:60 minutes
To enroll for this webinar, contact
webinars ( @ ) globalcompliancepanel dot com
Phone: 800-447-9407
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