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Regulatory Requirements for Medical Devices of Animal Origin

Online, Instructor-Led Course

Course Description

EG certification of medical devices manufactured utilizing materials of animal origin requires compliance to specific regulatory requirements such as Regulation (EU) No. 722/2012 and ISO 22442 standard series. Manufacturers often are challenged by these regulatory requirements especially when it comes to control of the quality of the animal material.

In this webinar, we will look into requirements applying for medical devices manufactured utilizing materials of animal origin specified in the European regulatory framework. The webinar will focus on the responsibilities of the legal manufacturer when it comes to control the sourcing, collection and handling of materials of animal origin.

Who Will Benefit?

Legal Manufacturers of medical devices manufactured utilizing materials of animal origin

Course Agenda

Part A: General overview on regulatory requirements for medical devices utilizing materials of animal origin (approx. 20 Minutes)

Part B: Requirements for controls on sourcing, collection and handling of materials of animal origin (approx. 1 h)

  • Responsibilities of the manufacturer of the medical device
  • Control along the production chain with focus on health inspection and certification, traceability, collection, handling, storage and transport of animal material
  • Specific requirements for materials from TSE-relevant species

Part C: Q&A session (approx. 10 Minutes)

Timing

11:00 AM – 12:30 PM

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