Loane Dousset

1. Quality Management System (QMS) design from scratch for PMEs and startups, following ISO13485 and 21CFR820, implementation and monitoring.

2. Missions in quality/regulatory compliance for QMS maintenance, design control records, product licence registration (export), batch release, technical file preparation for regulatory submission (MDR 2017/745), etc.

3. Missions in product industrialization :

- Support redaction of manufacturing process validation protocols and reports.

- Design transfer of a class III sterile implantable MD for the opening of a new manufacturing site in accordance with MDR 2017/745 and on-site audit for change approval.

1. Strengthening of the supply chain management process within the QMS and according to the applicable requirements.

2. Design History File preparation for implantable range of MD from design inputs to release to production according to US control guidance and regulations. Related technical documentation for a class III implantable sterile medical device according to the MDR EU 2017/745.

3. Audits participation (class III implantable MD): ISO 13485:2016, EU MDD surveillance, unannounced audit. ANVISA inspection preparation.