KEMA Quality

KEMA Quality, now integrated into DEKRA, is a premier provider of testing, inspection, and certification services for the global healthcare and life sciences sectors. The company operates as a prominent Notified Body (NB 0344), offering essential regulatory pathways for medical device manufacturers, including CE marking under MDR and IVDR. Their service portfolio encompasses ISO 13485 quality management system certification, product safety testing, and international market access support. By validating the safety and efficacy of medical technologies, KEMA Quality plays a vital role in bringing innovative healthcare products to market. The organization is headquartered in the Netherlands and maintains a vast network of laboratories and expert auditors worldwide.