First Steps to Medical Device manufacturing

• Module 1 An overview of the medical device sector in Ireland / Globally
• Module 2. What are medical devices and how do they work
• Module 3. Exercise
• Module 4. Regulations that govern the medical device sector - ISO 13485:2016 and 21 CFR Part 820 and 93/42 EEC
• Module 5. How Medical devices are classified and brought to Market within Europe, USA and Canada
• Module 6. Exercise
• Module 7. The role of Regulatory Bodies : Competent Authority - Health Products Regulatory Authority, FDA and notified bodies BSI,NSAI TUV etc - role within manufacturing
• Module 8. The role of Cleanrooms and classification of cleanrooms
• Module 9. Good Documentation Practice (GDP)
• Module 10. Work Instructions and importance of same
• Module 11. Change Control and Importance of same
• Module 12. Good Manufacturing Practice.
• Module 13. Device ideas? - How they make it onto the market
• Module 14. Device Design Systems
• Module 15. Basic Problem Solving Techniques

Programme Overview 

This first steps to medical device manufacturing training course is designed to introduce the trainee to understand the regulatory frameworks and infrastructure need to begin manufacturing medical devices

Who is the course for

The first steps to medical device manufacturing training course is suitable for individuals whom wish to work in this environment  or whom wish to begin medical device manufacturing.

Learning outcomes

Upon completion, participants will understand:

The Regulatory Framework for medical device manufacturing

The infrastructure requirements

Environmental controls