QA Compliances

As healthcare companies are becoming more inclined to value-based patient care, regulatory bodies have tightened the compliance requirements to increase transparency and ensure medical device quality and efficacy. With stricter norms and greater emphasis being given to patient safety, medical device manufacturers must establish processes to achieve compliance. ISD had obtained ISO13485 certification audited by TUV, Rhineland LGA Products, GMBH certification body and CE certification by Medical Device Safety Service GmbH. We also obtained approval from Malaysia Medical Device Authorities (MDA) and Good Manufacturing Practice Certificate (GMP) on all SKY GEL  products.