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Global Medical Device Laws and Regulations: US, EU, and Canada
This training on global medical device regulations will discuss the regulatory framework for medical devices in US, EU and Canada. It will outline systematic methods to identify and meet regulatory requirements and streamline the regulatory process in these countries.
Why Should You Attend:
Global regulations of medical devices are rapidly evolving, integrating the regulatory systems of the advanced medical device regulations. To be able to achieve sustainability and to remain sustainable and competitive in global medical device markets, it is necessary to streamline the regulatory process. To do so, we should understand differences in regulatory frameworks (regulatory requirements and compliance) in a sustainable and effective way.
This 90-minute training will discuss medical device laws and regulations in the USA, EU and Canada. It is intended to guide you through to understand and accurately interpret applicable laws and regulations governing medical devices in the above global countries. The presenter will guide participants from the medical device industry to streamline their business planning and regulatory strategy in these global markets.
Areas Covered in the Webinar:
- Medical device laws and regulations in the US, EU and Canada.
- Regulatory framework for medical devices in the US, EU, and Canada
- Device classification
- Regulatory requirements for medical devices including in vitro diagnostic devices in the US, EU and Canada.
- Contents of a 510(k) and PMA in US
- Contents of a technical file and design dossier in EU
- Content of a medical device license application in Canada
- How to identify and meet the regulatory requirements.
- How to establish and maintain systematic methods to meet the regulatory requirements.
- How to streamline the regulatory process
- Instructor’s unique regulatory guide.
Who will Benefit:
- Regulatory affairs (associates, specialists, managers, and directors)
- Clinical affairs (associates, specialists, coordinators, managers, directors and VPs)
- Quality assurance, quality control, and quality systems (associates, specialists, engineers, managers, directors and VPs)
- Research and development (associates, scientists, managers, directors and VPs)
- Product and development (associates, scientists, managers, directors and VPs)
- Marketing (associates, specialists, managers, directors and VPs)
- Site managers, and consultants
- Contract manufacturing organization (associates, scientists, managers, directors and VPs)
- Contract research organization (associates, scientists, managers, directors and VPs)
- Senior and executive management (VPs, SVPs, Presidents and CEOs)
- Contractors and subcontractors
Dr. David Lim, Regulatory Doctor, obtained his Ph.D. in biological sciences at the University of Missouri-Columbia and published his thesis research in the prestigious journal “Science.” Since then, he has held various positions at Duke, Caltech, US National Laboratories, Intrexon Corporation, Terumo, US FDA/CDRH, and EraGen Biosciences (A Luminex Company). In 2009, Dr. Lim served as a panel member during the FDA’s Transparency Public Meeting. Prior to founding his own consulting firm, www.RegulatoryDoctor.com, Dr. Lim was Senior Vice President of Scientific and Regulatory Affairs at Aquavit Pharmaceuticals. Regulatory Doctor provides Practical, Actionable and Sustainable/strategic Solutions in an Integrated, Thorough (PASS-IT) manner for all aspects of global regulatory, quality, clinical and compliance matters.
Dr. Lim has analyzed over 1,000 FDA warning letters, attended more than 50 FDA Advisory Panel Meetings, and analyzed the subject matters and decision-making processes in detail. He is familiar with more than 200 medical devices, IVD products, biologics, drugs and combination products. Dr. Lim is a certified professional for regulatory affairs (RAC) and also is a certified quality auditor (CQA) by the American Society for Quality (ASQ). In addition, Dr. Lim has completed two years in law school.
Dr. Lim is an auditor, regulatory coach, mentor, consultant and instructor for global matters pertaining to regulatory affairs, quality, clinical affairs and compliance.
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Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.
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