MDR & IVDR Service

Medical Devices Regulation (MDR 2017/745) and In Vitro Diagnostic Medical Devices Regulation (IVDR 2017/746)...

EU Representative Service

Delegated the EC Authorised Representative is the mandatory requirement for non-EU medical device manufacturers...

China NMPA Registration Service

Medical devices must obtain registration with the National Medical Products Administration (NMPA) before they can be legally marketed and sold on the Chinese market...

U.S FDA Registration Service

Medical devices must receive FDA clearance or approval from the Food and Drug Administration (FDA) prior to being legally marketed and sold on the U.S. market....

UKCA Marking Service

The UK Conformity Assessed (UKCA) mark demonstrates a product's compliance with UK statutory requirements, and when properly affixed, authorizes the product for legal market placement and commercial distribution on the UK market...

ISO 13485 Service

ISO 13485applies to medical device manufacturers and service providers obligated to fulfill both international and domestic regulatory requirements, as well as organizations seeking to implement documented quality management systems aligned with this standard...

Medical Device Compliance Consulting and Training

Medical device compliance consulting and training services empower manufacturers to successfully navigate complex regulatory landscapes and achieve seamless market entry in global jurisdictions....

Others

The Medical Device Single Audit Program (MDSAP) certification; Korea Compulsory Certification (KC Mark) for medical devices; and the Regulatory Compliance Mark (RCM) for electronic products in Australia/New Zealand...