Fertsy Inc today announced that its medical device software products and active medical device equipment R&D, production, and sales system has successfully passed comprehensive ISO 13485:2016 quality management system certification by SGS.
SGS Certification: The “Hard Currency” of the Global Market
As a global leader in inspection, testing, and certification services, SGS is a European Union Notified Body (NB 0120). Its ISO 13485 certificates are accredited by the United Kingdom Accreditation Service (UKAS) and hold mutual recognition in more than 140 countries and regions worldwide. This certification is not only a core market access requirement for products entering major markets such as the EU, U.S. FDA, and Canada, but also a key pillar of the Medical Device Single Audit Program (MDSAP).
Fertsy Technology’s selection of SGS is a deliberate choice to measure itself against the highest international benchmarks. This SGS certification conclusively proves that the company’s quality management system complies with the most rigorous international regulatory requirements, significantly bolstering the trustworthiness and competitive edge of its products in global supply chains, and establishing a solid foundation for its accelerated global expansion.