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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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Here are some mask and respirator types (and their respective filtering capacity) you should be aware of before reading this guide1. N95, N99, N100 standardsmaintained by the American National Institute for Occupational Safety and Health (NIOSH) N95at least 95%; N99,

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SGS Fimko Ltd is a notified body for Personal Protective Equipment and Medical Devices. It means that we are competent to perform the conformity assessments of products covered by legislation. The competent authority for PPE is Ministry of Social Affairs and Health, for

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