Regulatory compliance

Medical Device companies encounter the new European CE Medical Regulations (MDR/IVDR) regulations and new Quality system requirements as complex and being a heavy burden, with the knowledge that the effective date of the new EU regulations is 2020 June.

Focusing to upstream requirements/responsibilities/liabilities enforced to the medical device sector and the down steam PMS Reporting requirements, which are mandated to the Economic Operators eg. Manufacturer, Importer, Distributor and PRRC roles.

We have assess highly experienced medical device regulatory consultants in both Europe and the USA, who have led many successful regulatory filings, often liaising directly with the regulatory authorities on clients’ behalf.