Latest Medical Device Industry News & Trends

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Invitro Diagnostic Medical Device Manufacturers and the EU IVDR

August 24, 2021

The new In Vitro Diagnostic Medical Devices Regulation (2017/746/EU) (IVDR) bring EU legislation into line with technical advances changes in medical science, and progress in law making. At follow, you will have listed the changes that the IVDR involves for Invitro Diagnostic Manufacturers, and what IVDR manufactures should do to comply with it. RQMIS can help you providing In Vitro Diagnostic Medical Devices Regulation consultancy service to guide you in the new IVDR!

Interview: Barry Sands - FDA clearance success

August 9, 2021

FDA De Novo 510K clearance RQMIS consultancy services - Success story by providing regulatory and quality remote full service support. RQMIS expert consultants worked to achieve the medical device manufacturer goals

Official announcement of FDA user fees 2022

August 6, 2021

FDA provided information about the annual establishment registration fees, the small business program, and medical device user fees for Fiscal Year 2022 (FDA user fees 2022), which are effective October 1, 2021, through September 30, 2022. Apply with us for the FDA small business certification / application! SBD certification is here!