1 Mar 2022 | The team
I obtained my Ph.D in Microbiology after four years of exciting thesis at the CNRS of Marseille, I then moved on a Master’s degree specialized in innovation in the health sector in order to provide my services to companies. After more than three years as a...
1 Mar 2022 | MDCG
Theme Surveillance of requirements for Legacy devices Target Audience Notified Bodies Products Concerned MD Documents mentioned MDR (UE) 2017/745 MDCG 2021-25 MDCG 2020-3 MDCG 2019-10 rev.1 MDCG 2021-1 rev. 1 NBOG BPG 2009-4 Legacy devices with valid EC...
1 Mar 2022 | MDCG
Theme Conformity assessment Target Audience Notified bodies Products Concerned Class D IVD Documents mentioned IVDR (EU) 2017/746 MDCG 2020-16 rev.1 The MDCG 2022-3 guidance specifies the role and responsibilities of Notified Bodies in the verification of batches or...
28 Feb 2022 | The team
Hydraulic and fluid mechanics engineer, I fell into the medical device field a little by chance; and I did not come out anymore because it is so rich and varied! For nearly 15 years working within the medical device sector, I have fulfilled multiple roles as R&D...
28 Feb 2022 | The team
I have been in the medical device industry since the beginning of my career. I occupied several functions in the MD field; conceiving electro-medical devices, software validation, and managing the organization of companies. In my latest professional experiences, I had...