Our experienced in-house staff offers in-depth knowledge of EU and US/FDA medical device regulations and policies. The following services are offered in conjunction with R&D or manufacturing contracts or they are provided separately:

• Preparation and Submission of Regulatory Documentation for CE marking, FDA 510K Clearance and FDA PMA’s
• Preparation of documentation for Medical Ethics Committee (MEC) approval for clinical studies
• EC Authorized Representation Services

In addition to these in-house services, CMI has a strategic alliance with the medical device, IVD, & biotechnology consultants, CRO Group Inc of Boston MA. Together we provide all the services necessary to get your product onto the market throughout the world.