Efficient. Flexible. Compliant.

Effective solutions for global compliance.

Ford and Associates, a business unit of fotoMOJO, LLC, is a quality and regulatory compliance firm specializing in medical devices and combination products. We provide comprehensive strategic quality and regulatory compliance services, and assist with specific projects. Ford and Associates focuses on efficiency in attaining your compliance goals - we can provide boilerplate procedures, or customize documents to your needs. We offer expertise in USC Title 21 CFR Part 820, The Quality System Regulation, ISO 9001/ISO 13485:2003, 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 May 7, 1998 and amendments, Japanese r-PAL GMP, Ordinance No. 169, 21 CFR Part 11; Electronic Records; 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 specializing in FDA Class II and III Durable, Electronics, Implantables, Software, Sterile Medical Devices and drug/device combination products.

Ford and Associates provides ISO 13485:2003 certified audit services in accordance with ISO 19011