Michaël De Geest

I am a medical device QA/RA consultant and my strength is building and implementing lean Quality Management Systems according to ISO 13485.

I have worked for more than 8 years in the medical device industry and was involved in the design, production and delivery of active and non-active medical devices all around the world. I am specialized in complaint handling, CAPA process and root cause analysis, lean manufacturing and assisted/lead during NB, FDA and the authorities of Japan (JISK) audits.

My career followed in the IVD sector in which I was responsible for all the regulatory and quality tasks in the role of QA/RA officer and Management representative. In addition I supported the human resource department.

My fields of expertise are in :

Gap assessment and upgrade of the Quality management System towards ISO 13485:2016

Set-up, implementation and maintenance of a Quality Management System according to ISO 13485

Support, assist in vigilance procedures and tasks (CAPA, root cause investigation, complaint handling etc.)

(assist in) Set up, maintenance technical documentation for regulatory approval (e.g. DHF, STED, 510K etc.) and underlying documentation

Intermediate between company and Notified Body/Authority

Internal/supplier auditing



A detailed curriculum vitae will be provided upon request