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There are several accredited testing companies that provide MDD testing services for face mask products, which include Bureau Veritas, SGS, Intertek, and TUV. Quality Management System (ISO 13485) If your surgical masks are classified as sterile, then the MDD requires that the manufacturer has a quality management system (QMS) in place.

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An exception to this are surgical masks that are supplied sterile. They are class I(s) and the sterilization process must be be assessed and certified by a notified body, for example SGS Fimko Ltd. SGS CSTS Shanghai is accredited by China National Accrediation Services (CNAS) to perform testing according to standard EN 14683:2019.

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