What We Do

Staying on top of today’s ever-changing global regulatory requirements doesn’t mean you’ll sacrifice profitability and efficiency. A progressive perspective commensurate with the risk involved can provide a basis for cost-effective and efficient quality systems that won’t hinder your success.

Ford & Associates can help you establish a compliance strategy that addresses all aspects from development to global commercialization. We provide both strategic and tactical solutions to assist your organization in meeting its compliance objectives. New requirements in China, significant changes to the Medical Device Directive in Europe, a revised 510(k) review process, and new regulatory requirements for combination products are only a handful of the many changes that can have a major impact on your business.

Ford & Associates addresses these changes through systematic gap analysis and audits, and will recommend a compliance plan to keep your product on the market. We’ll even implement the changes for you. Below is a general list of services we provide.

  • 21 CFR 820 Compliance (FDA Class II and III)
  • Proposed Rule 21 CFR Part 4 Compliance
  • 21 CFR Part 11 Compliance
  • ISO 13485 implementation and management
  • CMDR / MDD / IVD / r-PAL compliance
  • California Sherman Act / Manufacturer Licensing
  • California Home Medical Device Retailer licensing
  • Gap Analysis
  • Mock Pre-Approval Inspection (PAI)
  • Mock FDA inspection
  • Supplier Audits
  • Internal Audits
  • SOP Development
  • Technical / Procedure Writing
  • Quality System Training
  • “483″ Response Letters
  • Project Management
  • Regulatory Submissions
  • Complaints
  • Recall and Corrections / Removal reporting
  • MDR – Vigilance
  • Risk Management – ISO 14971
  • Training Programs: Standardized or Customized