We support the Quality
Thanks to our long-term experience, we can fully assist you in the implementation of the Quality System for Medical Devices and Good Manufacturing Practice (GMP), in accordance with the requirements laid down in the regulation of the target Country.
- Pre-audit/orientative/gap-analysis for the verification of the Quality Management System (QMS) to GMP international requirements;
- QMS adjustment according to the ISO 13485:2016 requirements;
- QMS implementation/adjustment according to MDSAP requirements:
– U.S.A. (US Quality System Regulations 21 CFR 820);
– Japan (Ministerial Ordinance MHLW No.169);
– Brazil (DRC ANVISA No.16/2013);
– Canada (CAN / CSA-ISO 13485:2016:16);
– Australia [TG (MD) R 2002];
- Support during company inspections carried out by the Regulatory Authorities.
Strategic Regulatory Consulting
Italian and European Ministerial Registrations
International Registrations outside the EU