ISO internal auditor for FDA audit from Alpha Quality Assurance

FDA medical device audits


ISO 13485

ISO 13485 matrix

ISO 14001

Professional links 1

Professional links 2

About/contact us


Alpha Quality Assurance has over 28 years of experience with the FDA


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

Audits of FDA-regulated Medical Devices


Alpha Quality Assurance provides the medical device industry with a full range of regulatory rule assessment and quality system consulting, including audits for FDA and ISO requirements. Our services include mock FDA inspections, quality system and risk management system analysis, auditing, implementation and training, premarket regulatory support, dispute resolution and many other services.

ISO internal auditor helps client company with FDA auditAlpha Quality Assurance services include:


  • Conform and comply with the FDA's Quality System Regulations (QSR, 21 CFR 820) -Management Controls, Design Controls, Production and Process Controls, Document Controls, Sterilization, Validation, Packaging and Labeling requirements

  • Conform and comply with ISO 13485: 2003 Medical Devices - Quality Management Systems ISO 14971 Risk Management 21 CFR 809 in vitro diagnostic product labeling


  • Comprehensive vendor, facility, and documentation quality audits

  • Independent QS Regulation and Good Manufacturing Practice (GMP) audits

  • Simulated pre-approval inspections

  • Combined QS Regulation / ISO 9000:2000 / ISO 13485 pre-certification audits

  • Design control audits

  • Internal audit training

  • CAPA audits

  • Audit and assist with medical device Quality System Regulation (FDA's 21 CFR 820) and ISO 13485 quality management systems

  • Assess conformance to Good Clinical Practices (GCP)

  • Assess conformance to Good Laboratory Practices (GLP)


  • FDA inspections and trends

  • Respond to FDA 483 (Inspection Observations) and Warning Letters, Corrections and Removable 21 CFR 806

  • Direct corporate response to recalls 21 CFR 7, Medical Device Reporting 21 CFR 803 (Adverse Events)

  • Current US and EU Regulatory Requirements

  • Analytical Equipment Qualification, Calibration, Documentation & Maintenance

  • Validation of Computerized Production and Lab Systems

  • Handling OOS/OOT Results CGMPs for the Laboratory

  • Compliant laboratory recordkeeping

  • Risk-based vs. science-based approach

  • 21 CFR Part 11 and the latest FDA guidance

Alpha Quality Assurance   111 Nataqua Ave   Pacifica, CA 94044  650.359.4297

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