Ford & Associates

Founded in 2004 by Christopher Ford, Ford & Associates is a quality and regulatory compliance firm, specializing in medical devices and combination products. We provide comprehensive strategic quality and regulatory compliance and submissions services, and assist with specific projects. Ford & Associates focuses on efficiency in attaining your compliance and regulatory submissions goals. Christopher Ford’s experience spans 21 years with a specific emphasis on efficient quality management in high-tech manufacturing, primarily in the medical device manufacturing industry and with a focus on regulatory compliance in US FDA Class II and III device manufacturers. Ford & Associates provides a variety of quality and compliance services to a broad client base. We work with a wide range of devices and technologies including obstetrics/gynecology, clinical chemistry, physical medicine, radiology, neurology, immunology, pathology, hematology, and cardiology, to name a few. Christopher Ford's expertise includes: USC Title 21 CFR Part 820, The Quality System Regulation, ISO 9001/ISO 13485, European Parliament Directive 93/42/EEC, The Medical Device Directive, European Parliament Directive 98/79/EC, CMDR (Canada), SOR/98-282, P.C. 1998-783 , Japanese r-PAL GMP, Ordinance No. 169, 21 CFR Part 11 Electronic Records and Electronic Signatures, Government Code, Division 104, Part 5, State of California, Sherman Food, Drug and Cosmetics Law, including those parts relative to Home Medical Device Retailer, 21 CFR Part 4 (proposed rule) Current Good Manufacturing Practice Requirements for Combination Products