INTEGRATED ASSESSMENT SERVICES PTE LTD is providing ISO 13485 Certification Agency in Singapore. ISO 13485 is an international standard for the design, manufacture and distribution of medical devices. ISO 13485:2016 is the latest version by ISO.

ISO 15189 Certification is a laboratory accreditation standard. IAS coordinates with UQAS to deliver the laboratory accreditation with ISO 15189 Certification in Singapore .It is a comprehensive standard specifically meant for MEDICAL LABORATORIES.

Medical device manufacturer should appoint an experienced ISO13485 consultant who can work on all risk class devices. The associations need to cover the safety and risk information during product life cycle as per ISO 13485 demand. As an ISO 13485 medical device consultant, Operon Strategist identify the specific regulatory demand for the product similar as MDR, FDA 510( k) during the perpetration. This helps manufacturer in the further process of CE mark medical device or FDA 510( k) clearance.