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.
We can provide boilerplate procedures, or customize documents to your needs. 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
- FDA Class II and III Durable, Electronics, Implantables, Software, Sterile Medical Devices and drug/device combination products, as well as regulatory compliance and submission strategies.
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.