Scarlatti Fabrizio Email & Phone Number

Medical Device experience: Certification CE for MDD/AIMDD/MDR. Preparation of Technical Documetation and DHF. Class IIa, IIB, III. Implantable and active. Certification of medical devices in many countries: Singapore, Malaysia, India, Taiwan, US FDA, Honk Kong, China, Mexico, South Korea, Russia, etc.Design control, document control systems according to ISO 13485. Risk analysis per 14971.Complaint Handling and Vigilance in Europe and USA. Electrical and Electronic Equipment experience: Analysis of requirements of LVD, EMC, RoHS, ErP regulation/directives applicable to many types of devices from professional use to household equipment for the import of the product into the European Union. Preparation of technical documentation for the importer of products.Cosmetics: minor experience with EU cosmetic regulation.