Stéphane Giraud

• Manufacturing and distribution of MDR Class I and IIa orthopedic medical devices

• Management of the department and development of work policies

• Management of the NF EN ISO 13485 (2016) quality system and relations with authorities as a PRRC (Person Responsible for Regulatory Compliance)

• Quality and regulatory consulting

• Consulting, support, and QMS audits in the medical device manufacturing sector.

• Trainer in quality and regulatory for TUV Rheinland (Notified Body, training in internal quality audits, ISO 13485 (2016) standard, and MDR based on my profile and experience in medical device manufacturing standards).

• Manufacturing and distribution of Class IIa medical devices

• Management of the development of CE marking files for implants and electromedical devices.

• Process validation including ETO sterilization

• Management of the NF EN ISO 13485 (2016) quality system, change control, and relations with authorities

• Responsible for international registrations, Europe, Australia, USA, Japan.

• Quality and regulatory consulting

• Consulting, support, and QMS audits in the medical device manufacturing sector.

• Trainer in quality and regulatory for the Pôle des microtechniques de Besançon and for TUV Rheinland (Notified Body, training in internal quality audits, ISO 13485 (2016) standard, and MDR based on my profile and experience in medical device manufacturing standards).

• Consulting and support for the implementation or optimization of Quality Systems and conducting Quality System audits according to ISO13485 / ISO 9001 / Directive 93/42/EEC / 21CFR Part820 / RIM

• Consulting and support in the preparation of European, American, and Canadian market access files (devices of all regulatory classes)

• Trainer in quality and regulatory affairs (conducting in-company and inter-company training on standards 13485, 62304, 62366, 14971, on American, Canadian regulations, etc…),

• Conducting specific and adapted diagnostics and support on standards EN 62366 and 62304.

• Conducting regulatory diagnostics regarding Directive 93/42/EEC, strategic regulatory advice.