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What is it?
This program aim to allow Auditing Organizations (AO) to conduct a single audit on a medical device manufacturer that will satisfy the relevant requirements from participating jurisdiction.
The participating Jurisdiction are:
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U.S. Food and Drug Administration (FDA)
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Therapeutic Goods Administration of Australia (TGA)
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Brazil’s Agência Nacional de Vigilância Sanitária (ANVISA)
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Health Canada (HC)
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Japan’s Ministry of Health, Labour and Welfare, and theJapanese Pharmaceuticals and Medical Devices Agency (MHLW)
We provide these additional services to maintain Medical Device Single Audit Program
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Conduct internal audit
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Conduct audit to critical supplier
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Support external certification/surveillance audit
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Conduct gap analysis and closure on QMS​
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Provide regulatory strategy report
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Ad Hoc Consultancy on Quality, Risk Management & Regulatory
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