O'Brien, Des
Medical Device Regulations Roadmap: A Beginners Guide
- ISBN 13:
- 9781978202955
- author:
- O'Brien, Des
- format:
- Paperback
- publisher:
- Createspace Independent Publishing Platform
- language:
- English
- Publication Year:
- 2017
- Pages:
- 114
- Dimensions:
- 25.4 x 20.3 x 0.6 centimetres (0
- Genre:
- Science, Medical, Reference,
- Condition:
- New
- Availability:
- Item usually sent within 7 working days
Description
For those new to Medical Device Regulation, this concise guide provides a tangible resource for understanding the key themes and requirements within the EU framework. The book introduces the array of regulations across multiple jurisdictions, including Design, GMP, and manufacturing needs, making it an essential companion for engineers and medical device professionals starting out. This second edition includes the transition to the new EU MDR regulations, providing a foundation overview of the new rules and their structure.