What is ISO 13485?

ISO 13485:2016 determines prerequisites for a clinical gadget quality administration framework where an association needs to exhibit its capacity to give clinical gadgets and related administrations that reliably meet client necessities and administrative necessities material to clinical gadgets and related administrations. The essential target of ISO 13485:2016 is to encourage fit clinical gadget administrative prerequisites for quality administration frameworks. As result, it incorporates a few necessities for clinical gadgets and prohibits a portion of the prerequisites of ISO 9001 that are not fitting as administrative prerequisites. In light of these rejections, associations whose quality administration frameworks adjust to this International Standard can't guarantee adjustment to ISO 9001 except if their quality administration frameworks adjust to all the prerequisites of ISO 9001 All necessities of ISO 13485:2016 are explicit to associations giving clinical gadgets, paying little mind to the sort or size of the association

What are the benefits of ISO 13485

• - Increase access to more markets worldwide with certification.
• - Outline how to review and improve processes across your organization.
• - Increase efficiency, cut costs and monitor supply chain performance.
• - Demonstrate that you produce safer and more effective medical devices.