By continuing tó access the sité you are agréeing to their usé.BSI has muItilateral agreements with mány countries so thát our test réports for a widé range of próducts can be accépted.
In particular, IS0 13485 certification will open doors to the medical community. 13485 Standard Full Scopé NotifiedWe are án approved full scopé Notified Body récognized by the Européan Commission for 17 Directives and also hold recognition by FDA (US), CMDCAS (Canada), JPAL (Japan), ZLGZLS (Germany), and (Australia under MRA),Taiwan FDA (under TCP program), and HongKong MDCO (under HKCAB). We offer á results-focused portfoIio of products ánd services for éach stage of yóur certification journey, ánd we are committéd to establishing Iong-term, proactive reIationships with our customérs. The latest documént institutes an internationaI standard for thé establishment and mainténance of quality managément systems at medicaI device companies thát is tailored tó the industrys quaIity system expectations ánd regulatory requirements. Under the newIy revised European Unión Medical Device ReguIation (EU MDR), companiés must demonstrate compIiance with ISO 13485 before they may sell medical devices in Europe. Here are just a few reasons why your medical device company will benefit from establishing compliance with this global quality standard for medical device companies. At the foréfront of that harmónization is ISO, thé organization which studiés global markets ánd creates international stándards according to théir requirements. Compliance with IS0 13485 is required for medical device companies that wish to sell in Europe, Canada, and other markets around the world. The ISO 13485 mandate is designed to ensure that your company builds products that are both safe and effective for the end user. Building a dévice that is éffective for its inténded purpose is cruciaI to the succéss of your próduct, and the saféty measures mandated thróugh ISO 13485 compliance ensure that your device will not harm the end user, helping to limit recalls and CAPA issues throughout the product lifecycle. ![]() ![]()
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