Medical Devices Utilizing Materials of Animal Origin Regulatory Training
This one day course has been designed to provide manufacturers with the knowledge and skills to interpret the regulatory requirements related to producing medical devices utilizing materials of animal origin, including those for which a transmissible spongiform encephalopathies (TSE) risk is expected.
When you attend this course, you will learn how to reduce risks and uncertainty as you progress through the EU regulatory process.
You’ll gain an appreciation of typical hazards associated with animal tissues & derivatives, the justifications needed to use these materials and awareness of common mistakes to avoid in sourcing, collection and handling ensuring delays are minimized.
This course focuses on helping you determine the applicable European legislation and guidance including 93/42/EEC, 90/385/EEC, 722/2012, BS EN ISO 22442 and MedDev 2.11/1.
Who should attend?
This course is delivered in-house and recommended for:
- Medical device product managers
- Medical device product designers
- Medical devices product testers
- Regulatory affairs professionals
Learn the regulatory requirements when producing devices utilizing materials of animal origin.
What will I learn?
- How to determine the current legislative approval process
- What are the key stages in the consultation process under 722/2012
- What is required of you in order to justify the use of materials of animal origin
- What is required of you to demonstrate control over your suppliers of materials of animal origin
- What are the Notified Body expectations when submitting documentation
- To identify common pitfalls and potential Notified Body and / or Competent Authority questions
- To identify the requirements for gathering post-production information
How will I benefit?
- Your business will be able to effectively deal with the many different aspects of regulation that applies to the production process
- Your organization will be in a better position to mitigate risks and reduce uncertainty as your product moves through the EU regulatory process
- Your business can move your product more efficiently to market which can reduce or avoid delays and the cost implications associated with this
- Certificate of attendance
- In-company options should be discussed during booking