Nicolas Gremaud Email & Phone Number

Besançon, Bourgogne-Franche-Comté, France

Porrentruy, Switzerland

Brézins - Rhones Alpes - France

Electromedical devices, softwares, class I, IIa and IIb- CE mark (creation and update of technical files (STED)).- Participation to 510(k) preparation.- Regulatory strategy and support for new infusion systems development.- International registrations and renewals (China, Brazil, Japan, Canada, South Korea, Russia, Singapor,…).- Cross-Group projects (Labelling, traceability tools).- Regulatory and normative survey.- Writing and implementation of trainings.- Cleaning and disinfection.- Change management.- Achievement of internal audits and participation to external audits (GMED, TÜV SÜD), process improvement.

Brézins (38)

Electromedical devices, softwares, class I, IIa and IIb- CE mark (creation and update of technical files (STED)).- Participation to 510(k) preparation.- Regulatory strategy and support for new infusion systems development.- International registrations and renewals (China, Brazil, Japan, Canada, South Korea, Russia, Singapor,…).- Cross-Group projects (Labelling, traceability tools).- Regulatory and normative survey.- Writing and implementation of trainings.- Cleaning and disinfection.- Change management.- Achievement of internal audits and participation to external audits (GMED, TÜV SÜD), process improvement.

Brézins

Electro-medical devices (infusion systems), class I, IIa, IIb- Change management : evaluation and management of changes on medical devices- CE mark (creation and update of technical files (STEDs)).- International registrations and renewals (China, South America).- Support for new infusion systems development

Besançon

Project management, writing of quality procedure, hospital certification, Use of A.M.D.E.C. method, management of medical devices criticity, technological surveillance, purchase management (plan), radiation hygiene, user needs identification.

Région De Paris, France

Thèse professionnelle concernant la flexibilité en architecture hospitalière. Interactions technologies médicales et bâtiments, évolutivité des hôpitaux, visites d'hôpitaux

CE mark files (cardiac biodegradable implant, class III, and accessories class 1), ISO 13485 certification, update and improvement of the quality system, product conformity tests management, internal and external audits (GMED), sterilization, clean room, clinical trials, risk management.

Besançon

Development of a micro-biological sensor, clean room, micro-manufacturing.

Besançon

ISO 13485 conformity, creation of the quality system, internal and external audits (GMED).

Montbéliard

Mastère Spécialisé Équipements Biomédicaux - Cycle Ibmh, Dispositifs Médicaux

Génie Biomédical

Activities and Societies: - Sciences de l'ingénieur - Sciences biologiques et médicales - Qualité et Réglementation des dispositifs.