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FDA medical device audits CAPA 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 kenmiles@alphaqa.biz .

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 audit Alpha Quality Assurance services include:

QUALITY SYSTEM REQUIREMENTS ADVISOR

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

AUDIT CAPABILIITES

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)

REGULATORY AFFAIRS

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 info@alphaqa.biz

FDA Medical Device audits CAPA ISO13485 ISO13485 matrix ISO14001 Links1 Links2 About us

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