Introduction to FDA and EU Medical Device Submissions
Duration : 60 Minutes
Charles H. Paul,
Charles H. Paul is the President of C. H. Paul Consulting, Inc. – a regulatory, training, and technical documentation consulting firm. Charles is a management consultant, instructional designer and regulatory consultant and has led C. H. Paul Consulting, Inc. since its inception over 25 years ago. He regularly consults Read more
The medical device market is the largest market of all of the life sciences and it is generally valued at upwards of $90 billion with the expectation of continuous growth. This growth demands that the market be continually fed with new and innovative products.
Regulation, here in the US as well as in the EU have made the approval of products for market a complex process requiring manufacturers, to ensure their own survival, to be fully knowledgeable of the regulatory submissions process.
Course Objective:
The basic requirements for medical device regulatory submissions are essentially the same between the FDA and EU while the individual country and region requirements for submission are somewhat different.
It is imperative to understand the similarities and differences when formulating a marketing strategy for the countries in which a medical device will be marketed.
Why Should You Attend:
This webinar will detail the 510K and PMA processes as well as the EU requirements comparing and contrasting those regulations and submissions requirements. No discussion of medical device submissions would be complete without addressing device classifications for both the US and the EU. Properly classifying medical devices is crucial to an effective submissions process.
Finally, this webinar will address quality system certification, product certification and technical files and dossiers.
Course Outline:
• 510(k) and PMA processes (US FDA)
• Current EU Directives (MDD, AIMD, IVDD)
• Intended use
• Indications for use
• IDEs, HUDs
• Quality system certification
• Product certification
• Technical files and design dossiers
What You Get:
• Training Materials
• Live Q&A Session with Our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points
Who Will Benefit:
This webinar has been designed for professionals new to the field and who require submissions knowledge to support their job function. These professionals include engineers, managers, supervisors, scientists, technicians involved in product development, manufacturing, quality assurance, or regulatory affairs for medical devices.
Please reach us at 1-888-844-8963 for any further assistance or if you wish to register
100% MONEY BACK GUARANTEED
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