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 services and project strategies are based on a business-oriented approach. We take care to understand each client's US and global marketing objectives to assure that the regulatory strategy complements and supports plans for international commercialization. Our corporate culture fosters innovative thinking; we thrive on the complicated and complex regulatory challenges that are commonly associated with the most ground-breaking technologies.

Our Regulatory Services include preparation of presubmissions, 510(k)s, IDEs, HDEs, and PMAs. We have successfully submitted a number of de novo petitions (de novo 510(k)s), we have contributed to both industry-sponsored and FDA-sponsored reclassification petitions, and we have taken a number of products through the Humanitarian Device Exemption (HDE) process.

During product development and postmarket activities, our Quality Systems specialists help to design and prepare QS Manuals and SOPs, conduct internal audits, support clients through FDA audits, and assist clients to resolve 483 observations and Warning Letters.

We provide Clinical Study Design and Clinical Research Management Services, including site management and site monitoring, for small clinical performance studies to support 510(k) submissions as well as for large multicenter pivotal studies to support PMAs. We have also managed Post Market Clinical Followup (PMCF) studies to support CE marking.

Our International specialists have extensive experience in the preparation of Technical Files for CE marking and Health Canada Medical Device License applications. Our Medical Writers have prepared more than one hundred Clinical Evaluation Reports (CER) for our clients.