How to create your Technical Documentation? [EU MDR and IVDR]
The creation of a Technical File or Technical Documentation for CE marking is really a challenge sometimes. After successfully passing audits with my customers, I want to share with you some best practices to create your Technical Documentation. I will even explain to you how to reference your annexes or what to do with the GSPR. So don’t miss it.
Who is Monir El Azzouzi?
Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies and particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people have a better understanding of the Medical Device Regulations all over the world. He now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, podcasts, online courses…
- EU MDR 2017/745: https://eur-lex.europa.eu/legal-content/EN/TXT/?qid=1589797311848&uri=CELEX:02017R0745-20200424
- EU IVDR 2017/746: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02017R0746-20220128#tocId129
- How to comply with GSPR: https://easymedicaldevice.com/gspr/
- Technical Documentation blog post: https://easymedicaldevice.com/technical-documentation/
- How to write your declaration of conformity: https://easymedicaldevice.com/declaration-of-conformity/
- eQMS Scube SmartEye: https://scube-technologies.com/
- Easy Medical Device Shop: https://school.easymedicaldevice.com/shop/