Also known as: FordandAssoc
Quality and regulatory compliance consultant, specializing in medical devices and combination products. I provide comprehensive strategic quality and regulatory compliance and submissions services, and assist with specific projects. Over years progressive quality management experience in high-tech manufacturing, primarily in the medical device manufacturing industry and with a specific focus on regulatory compliance in US FDA Class II and III device manufacturers. Providing a variety of quality and compliance services to a broad client base, I work with a wide range of devices and technologies including obstetricsgynecology, clinical chemistry, physical medicine, radiology, neurology, immunology, pathology, hematology, and cardiology, to name a few. Specialties CFR Compliance (FDA Class II and III) Proposed Rule CFR Part Compliance CFR Part Compliance ISO 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 Response Letters Project Management Regulatory Submissions Complaints Recall and Corrections Removal reporting MDR Vigilance Risk Management ISO Training Programs Standardized or Customized
