|GMED||Global Head of Regulatory Affairs||France|
| Final stretch to MDR/IVDR implementation: How are companies revising their strategy to comply with the key requirements and associated timelines? |
Corinne Delorme is the Global Head of Regulatory Affairs within GMED Group.
She has been particularly involved in the implementation of medical device regulations in various regions (Europe, US, Canada, Australia, Brazil, Japan, Taiwan).
The various operational positions (management of certified companies, auditing) and management positions that she has exercised within the French Ministry of Health and a certification body specialized in medical devices forges her regulatory convictions and her knowledge of the sector. She is involved in determining a regulatory compliance strategy tailored to GMED certification body role.
By virtue of her role within the GMED and considering her personal conviction that it is necessary to be a player in the evolution of the regulatory framework, she is involved in several working groups at European and international level. Over the past 2 years, she has focused her involvement on the development of post-market evaluation procedures and MDSAP.
She chairs the AFNOR S95B Commission “Quality Management and Related General Aspects of Medical Devices” and is a member of the associated ISO standards groups.
She also develops training sessions.