Skin care company Crown Aesthetics reported on Wednesday the receipt of Medical Device Single Audit Programme (MDSAP) certification upon a rigorous audit by BSI (British Standards Institute).
Following MDSAP certification, the company will continue selling SkinPen, the first FDA cleared microneedling device, in Canada, Australia, Brazil and Japan.
MDSAP allows a single regulatory audit of a medical device manufacturer's quality management system to satisfy the requirements of multiple regulatory authorities. It covers the requirements of ISO 13485:2016 plus Good Manufacturing Practices (GMP) for each applicable regulatory authority. MDSAP is validation of the company's world-class service and pursuit of quality, safety and efficiency.
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