Marcia McKay's Company Details
New York, NY, US • 50 - 99 Employees
Medical Equipment
M Squared Associates provides FDA regulatory, clinical research (CRO) and quality systems consulting services to domestic and international medical device companies. Our full time staff includes experienced professionals from the medical device industry and from FDA. Our core strength is developing and executing project strategies that meet each individual client's business objectives for introducing new products to US and international markets.
Medical Devices
Biotechnology
US Food and Drug Administration (FDA)
Regulatory Strategy
PMA
IDE
De Novo
HDE
510(k)
Registration and Listing
US Agent
CRO
Clinical Trials
Biostatistics
Clinical Study Management
Data / Database Management
Quality Systems
ISO 13484
Design Controls
Medical Writing
Software as a Medical Device
Due Diligence
Medical Equipment
Medical and Hospital Equipment