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ISO 13485

ISO 13485 matrix

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About/contact us



Ken Miles was formerly a senior FDA medical device investigator


Alpha Quality Assurance Associates
111 Nataqua Avenue
Pacifica, CA 94044
Phone 650.359.4297
Fax 650.359.6171

About Alpha Quality Assurance  

Experience counts. Alpha's principal, Ken Miles (, has 28 years experience as a senior FDA medical device investigator. As an FDA consultant, he can help you navigate the regulatory passageways to maintain processes certification and lead you to device approval. FDA consultant Ken Miles spent 28 years with the FDA before starting Alpha Quality Assurance

Ken Miles assists the medical device industry in complying with FDA requirements. Ken's expertise includes evaluating Good Manufacture Practice (GMP) and Good Laboratory Practice (GLP) compliance, Quality System Regulations, and QSIT certification inspections (Management, Design, Process Controls, and CAPA).

He also specializes in sterilization validation, in vitro diagnostic and radiological health product  (i.e. diagnostic x-ray imaging equipment, laser systems, etc) performance standards.  Ken Miles retired from the US Food and Drug Administration as the Agency's Pacific Regional Radiological Health Representative / Emergency Response Coordinator and Medical Device Specialist. 

His responsibilities included technical assistance, comprehensive reports and recommendations to management and technical staff regarding individual and industry-wide compliance issues. His conducted medical device inspections throughout the Western US, Canada, Europe and Asia.  

His clients range from small start-up companies to global corporations with domestic and foreign manufacturing sites that produce a variety of medical device products including x-ray imaging and therapeutic systems, surgical instruments, catheters, in-vitro diagnostic (IVD) products.


  • Mock FDA inspections with written reports with findings, citations of regulations and requirements, and recommendations
  • Conducts audits of radiation-emitting medical devices (diagnostic and therapeutic x-ray imaging systems, laser devices, ultrasound devices  and other radiation-emitting device) for conformance to Radiological Health performance standards FDA 21 CFR 1000-1050
  • Provides expertise to radiological health manufacturers and importers for compliance with FDA's performance standards for radiation-emitting products. Provides written reports with findings, citations of regulations and requirements, and recommendations. 
  • Reviews and makes recommendations covering Quality Records such a Quality Manuals, procedures, work instruction, and forms for conformance to FDA regulations and International Standard Organization requirements
  • Device and in-vitro diagnostic (IVD) Good Manufacturing Practices (GMP),
  • Quality System Regulations (QSRs)
  • Quality System Inspection Technique requirements (Design Control, Management Control, Manufacturing and Process Controls, CAPA, MDRs, Recalls, 21 CFR Part 11 (Electronic Records and Signatures)
  • Sterilization Validation. 
  • Compliance with QSR and International Standards Organization (ISO) requirements. 
  • Gap analysis of documents for compliance of QSR and ISO 13485:2003 and ISO 14971 Risk Management requirements.
  • Complaint handling, Medical Device Reporting (MDR) and Correction and Removal programs and operations. 
  • Premarket Notification 510(k) documentation to FDA�s Center for Devices and Radiological Health (CDRH).
  • Assist device and pharmaceutical manufacturers with Good Laboratory Practice and Clinical Study compliance.
  • Provides presentations to industry on FDA related topics.
  • Good Laboratory Practices audits
  • Clinical study regulatory requirements
  • Conducts ISO 14001:2004 Environmental Management System audits


  • Regulatory Affairs Professional Society
  • American Society for Quality, Biomedical Div., San Francisco and Santa Clara Divisions
  • Health Physics Society, Northern California / Sierra Chapter, and San Francisco Bay Area Chapter
  • American Association of Physicist in Medicine, San Francisco chapter
  • American Nuclear Society, Bay Area chapter


Alpha Quality Assurance  111 Nataqua Ave   Pacifica, CA 94044  650.359.4297

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