Quality & Regulatory Consulting Services

Primo Medical Group’s Quality Management System Implementation and Regulatory Consulting Services provide a full range of consulting support services to U.S. and international clients in the medical device industry. We have many years of experience in building quality systems that meet or exceed industry requirements. We are also proficient in creating regulatory submissions in the United States and abroad.

Primo Medical can assist with a wide range of services that cover all the stages in the development process, ensuring products meet the quality system requirements of regulatory authorities.

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 (Brazil) registration
ITAR Registration