Organization of Regulatory and Clinical Associates
P.O. Box 3490
Redmond, WA 98073
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Webinar - Medical Devices Manufactured Utilizing Tissues of Animal Origin
Registration is required before Monday, May 13, 2019 at 12:00 AM
The link to the webinar is intended for the registered person ONLY and should not be shared.
All attendees MUST be registered.
TOPIC: This presentation will provide an overview of the EU regulations, submission process, and unique considerations for medical devices manufactured utilizing tissues of animal origin.
TOPIC DESCRIPTION: Animal tissues and their derivatives are utilized in a wide range of devices, and can be the entire device (e.g. heart valves), part of the device (e.g. gelatin, heparin) or be used in the device manufacturing process (e.g. tallow derivatives). In order to control the potential risks associated with these materials, while achieving the required performance of the devices, manufacturers must consider process controls from sourcing through final manufacturing. Manufacturers must also be aware of the additional regulatory requirements that must be met for these devices and develop appropriate regulatory strategies in order to place and maintain these products on the EU market.
SPEAKER: Mindy McCann
SPEAKER BIOGRAPHY: Mindy has broad and multi-faceted experience in medical device international regulatory affairs and quality management, having worked for a start-up, large global company and two notified bodies. In these roles Mindy has both developed and reviewed processes and submissions for products that utilize tissues of animal origin.
Mindy’s enthusiasm for regulatory compliance, communication skills and leadership skills make her an effective project manager and engaging trainer. Mindy’s hands-on experience as a development engineer, notified body auditor and technical file reviewer, global certification manager, and regulatory and business executive has led to a practical approach in developing and implementing regulatory strategies and quality procedures; auditing; and writing and reviewing clinical evaluation reports, technical documentation, and clinical investigation protocols and applications.
WHO: Clinical, regulatory, quality, manufacturing and legal
Attendance at this meeting may be applied as 1.5 points towards RAC re-certification
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