In 2008, MEDRIG Medical Device Consulting Co.,Ltd. was founded in New Jersey to assist domestic medical device manufactures with compliance with FDA 510k regulations. And also being a parnter with US labratories and third parties, we source suitable labs for our clients.
In 2012, MEDRIG open a window to Chinese medical device manufacturers. We are able to provide the full solution of marketing approval.
MEDRIG is proud to offer service including:
• 510k submission consulting
• US laboratory with ISO 17025 accreditation sourcing
• The third party testing consulting
• CE Technical Files consulting
• TGA procedure and Files consulting

Our advantage:
• Consultant team members are from medical filed and notified-body and with enrich experience
• Professional knowledge on FDA 510k’s procedure and document requirement; assist to prepare and perfect the document
• Familiar with FDA consume standards and testing lab resources; Search and provide more optional lab promptly to greatly shorten testing term

Our parnters:
TÜV SÜD America Inc.
Intertek Testing Service Co., Ltd.
Cambridge Polymer Group, Inc.
Knight Mechanical Testing Inc.