REGULATORY CONSULTING SERVICES

Primo Medical Group Regulatory Consulting Services provide a full range of regulatory consulting support services to U.S. and international clients in the medical device industry.

Primo Medical can assist with a wide range of services that cover all of the stages in the development process ensuring products meet the requirements of regulatory authorities. Through our close contact with regulatory bodies, we are able to anticipate and advise you on new US and international developments.

Our medical device regulatory consulting services include:

• Regulatory strategies
• Device classification
• Predicate device identification
• Pre-IDE submissions and meetings
• Protocol design
• IDE applications
• 510(k) submissions (traditional and special)
• De Novo submissions
• PMA and PMA supplement submissions
• FDA 483 letter responses
• Warning letter resolution
• Medical device reporting
• Liaise with FDA and European authorized representatives
• CE marking
• ANVISA registration