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The US Food and Drug Administration (FDA) regulates the United States’ medical devices market. To sell in the US, most manufacturers are required to have a quality management system (QMS) based on 21CFR Part 820, although no certification is required or issued.

SGS is approved under the Accredited Persons Programme to undertake FDA Site Inspections (also known as FDA Audits) and can offer this service globally from our network of local offices. Our audits check the FDA regulatory compliance of your quality management system against the Code of Federal Regulations CFR 21 Part 820 Quality System Regulation and associated regulations (usually Parts 11, 803, 806 and 821). Audits can be carried out directly on behalf of the FDA, when conditions allow, or as a gap analysis in preparation for an FDA Site Inspection.

SGS UK was the first certification body to be approved under this programme and has been undertaking FDA Site Inspections since 2000.

FDA Site Inspections can often be combined with other scheduled audits such as MDSAP (PMAP programme) and CE marking to reduce significantly the total audit cost and time to the company management. The right medical device certification at the right time is the key to winning contracts, launching new products and entering new markets. Regulatory compliance demonstrates your commitment to meeting your customers’ requirements.

Meet FDA QMS standards with an FDA Site Inspection from SGS.