Introduction to Medical Device Manufacturing

Training Benefits will include:

1. An overview of the medical device sector in Ireland / Globally

2. Explanations regarding the regulations that govern the sector

3. ISO 13485 - What is it?

4. FDA - Who are they and what do they require?

5. Typical work practices required of operators

6. Expectations for technical, scientific and management staff

7. What is it like on the inside of a facility?

8. Medical devices in operation

9. What are Class I, II, III devices?

10. Typical employment conditions

11. The controlled environment and room classification

12. Device ideas? - How they make it onto the market

13. Device design systems

14. Basic problem solving techniques

15. Good Manufacturing Practice

Every participant will have the opportunity to identify key requirements in advance of the course.

Free follow up consultation will be available post training from your course tutor. 

Who should attend?

Personnel who have minimal knowledge of the Medical Device Manufacturing sector and working environment but would like to understand what is expected. Suitable for personnel who may be interested in joining or converging with the medical device sector or those who have just joined and would like a broad overview of the requirements.