FDA Regulatory and Clinical Services for the Medical Technology Industry

Since 2001, M Squared Associates has provided a full range of regulatory, quality and clinical consulting services to US and international medical technology firms. We specialize in devices and combination products that are reviewed by FDA's Center for Devices and Radiological Health (CDRH). Our corporate culture fosters innovative thinking; we thrive on the complicated and complex regulatory challenges commonly associated with ground-breaking technologies.

FDA Regulatory Consulting Services

We take care to understand each client's US and global business objectives to assure that the regulatory strategy complements and supports plans for commercialization. Learn more...

Quality Systems and Quality Management Consulting Services

Our Quality specialists work with our clients to design and implement QM Systems in compliance with 21 CFR Part 820 and ISO 13485. Learn more...

Clinical Research Organization

We tailor our full service CRO capabilities to accommodate budget and timeline requirements for small feasibility studies, usability studies, clinical performance or marketing studies, and multicenter pivotal studies to support PMAs. We have experience conducting clinical trials with international companies, with clinical sites in the US, Canada, Brazil, Mexico and the EU. Learn more...

International Regulatory Services

Our specialists have extensive experience in the preparation of Technical Files for CE marking and Health Canada Medical Device License applications. Learn more...