What happens after the IVDR Date of Application with Colm O’Rourke
The IVDR 2017/746 will become live on May 26th, 2022 and this will be the big day for a lot of IVD companies.
To talk about the situation under IVDR, I have invited Colm O’Rourke from Trinzo to help us. Colm is sharing with us the situation for manufacturers. Also about Notified Bodies.
Who is Colm O’Rourke?
Colm O’Rourke is a regulatory and quality consultant with 10 years’ experience working in the medical device industry, including notified body, diagnostics manufacturer, and clinical laboratory experience. Colm works with manufacturers to achieve compliance through strategic planning, supporting the development of compliant technical and quality documentation, and assisting with regulatory submissions. Colm also delivers training on a number of topics including EU MDR and IVDR. Colm is a graduate of UCC, Ireland with a BSc in Biomedical Science, and NUI Galway, Ireland with a Dip. in Medical Device Science
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…
- Colm O’Rourke LinkedIn Profile: https://www.linkedin.com/in/colm-o-rourke-37b53044/
- MedDev Solutions Website: https://www.meddevsolutions.co.uk/
- MDCG 2022-6 IVDR significant changes: https://ec.europa.eu/health/document/download/14c2d8dd-8489-4db5-b035-1c174f17fb54_en?filename=mdcg_2022-6.pdf
- Meddev Solutions IVDR training: https://www.meddevsolutions.co.uk/euivdr
- EU IVDR Guidebook (10% off with the code: EASYMEDICALIVD): https://www.meddevsolutions.co.uk/ivdrguidebook