FDA Regulatory and Clinical Services for the Medical Technology Industry

Services: Quality Systems and Quality Management Consulting

Our Quality specialists work with our clients to design and implement QM Systems in compliance with 21 CFR Part 820 and ISO 13485. We prepare QS Manuals and SOPs, conduct internal audits, support clients through FDA audits, and assist clients to resolve 483 observations and Warning Letters.

Quality Systems and Quality Management Services offered by M Squared Associates includes: