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AQA provides an iso 14001 internal auditor to review ISO 14001conformanceissues and provide an ISO 140001 audit checklist

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FDA medical device audits. Alpha Quality Assurance can help you conform to and obtain ISO 14001 self-certification. Alpha Quality Assurance Associates. Pacifica, CA 94044. Phone 650.359.4297. Fax 650.359.6171. ISO 14001:2004 Environmental Management Systems. ISO 14001 is the cornerstone of the ISO 14000 series. It specifies an Environmental Management System that an organization can obtain through third party certification. ISO 14013/5 provides audit program review and assessment material. ISO 14030 prov...

proactive.uk.com

Proactive Marketing Communications

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Engineeringtalk: news for product design and automation engineers. Electronicstalk: news for electronics design and production engineers. Web site and PowerPoint presentation design, LCD projector hire and sales. Proactive Marketing And Communications Ltd. 37 Ramsdell Rd, Fleet, Hampshire, GU51 1DD. Tel: 44 (0)1252 642444 Mobile: 44 (0)7900 886855 Fax: 44 (0)1252 676544. Email: info@proactive.uk.com.

alphaqa.biz

ISO 13485 conformance

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FDA medical device audits. Alpha Quality Assurance can help you set up, monitor and conform to an ISO 13845 quality system. Alpha Quality Assurance Associates. Pacifica, CA 94044. Phone 650.359.4297. Fax 650.359.6171. ISO 13485:2003 Quality Management System Requirements. Alpha Quality Assurance can help you set up, monitor and conform to an ISO 13485 quality system. What is the difference between ISO 13485 and ISO 13488? Who can be certified to ISO 13485:2003? Consultants that design, manufacture, and a...

alphaqa.biz

ISO 13485 conformance

http://www.alphaqa.biz/FDA_ISO13485.htm

FDA medical device audits. Alpha Quality Assurance can help you set up, monitor and conform to an ISO 13845 quality system. Alpha Quality Assurance Associates. Pacifica, CA 94044. Phone 650.359.4297. Fax 650.359.6171. FDA Regulations and ISO 13485:2003 implementation matrix. ISO 13485 is a medical device quality systems standard that supplements ISO 9001. The following chart shows the correlation between FDA regulations and ISO13485:2003. Key Quality System Areas and Functions. 61 - 6.2 -6.3. 73, 806, 810.

alphaqa.biz

How to systematically approach and pass your FDA medical device audit

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FDA medical device audits. Alpha Quality Assurance provides these professional links as a service to the medical device industry. Alpha Quality Assurance Associates. Pacifica, CA 94044. Phone 650.359.4297. Fax 650.359.6171. 510(k) Information and Releasable Database. Code of Federal Regulations (CFR). Electronic Products Radiation Control. Export of Medical Devices. Federal Food, Drug, and Cosmetic Act. FDA's' Centers Small Business Contacts. Good Guidance Practices (GGP). Reuse of Single Use Devices.

alphaqa.biz

About Alpha Quality Assurance and FDA consultant Ken Miles

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FDA medical device audits. Ken Miles was formerly a senior FDA medical device investigator. Alpha Quality Assurance Associates. Pacifica, CA 94044. Phone 650.359.4297. Fax 650.359.6171. About Alpha Quality Assurance. Experience counts. Alpha's principal, Ken Miles (kenmiles@alphaqa.biz), 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. His resp...

alphaqa.biz

FDA ISO internal auditor and consultant

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FDA medical device audits. Alpha Quality Assurance has over 28 years of experience with the FDA. Alpha Quality Assurance Associates. 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,. Alpha Quality Assurance services include:.

alphaqa.biz

FDA professionl links 1

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FDA medical device audits. Alpha Quality Assurance provides these professional links as a service to the medical industry. Alpha Quality Assurance Associates. Pacifica, CA 94044. Phone 650.359.4297. Fax 650.359.6171. Title 21 Code of Federal Regulations. Medical Device Directive (93/42/EEC) Text. In Vitro Diagnostic Medical Device Directive (98/79/EC) Text. Directive as regards medical devices incorporating stable derivates of human blood or human plasma (2000/70/EC). List of Notified Bodies.

alphaqa.biz

Corrective and Preventative Action - CAPA

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FDA medical device audits. Alpha Quality Assurance provides CAPA guidance for new or existing quality systems. Alpha Quality Assurance Associates. Pacifica, CA 94044. Phone 650.359.4297. Fax 650.359.6171. Corrective And Preventive Action (CAPA). CAPA (Corrective And Preventative Action) systems the No. 1 target of FDA inspections? Why do they account for 50 percent of all warning letters? What a poor CAPA system looks like and how it triggers citations. How to thoroughly conduct a problem investigation.