• 2021 Warning Letters list from FDA for Med Devices

    25 February 2022 EU MDR
    S.No Date Warning Description Manufacturer Product(s) Summary 1. 25-Jan-2021 CDRH ...
  • ISO 15223 Labeling New Version Changes

    10 February 2022 EU MDR
    ISO 15223-1 Gap Analysis EN ISO 15223-1:2016 EN ISO 15223-1:2021 ...
  • Harmonised Standards for Medical Devices in Support of Regulation (EU) 2017/745

    8 February 2022 EU MDR
    The European Commission officially recognized nine harmonised standards for medical devices in ...
  • 8 key Questions & Responses on Clinical Investigation under EU MDR

    20 January 2022 EU MDR
      1. Difference between the performance, clinical performance and clinical ...
  • EU MDR – Medical Device Labeling Changes & Challenges

    8 September 2021 EU MDR
    Global rollout of EU MDR and other UDI-type of regulations are driving all medical device companies ...
  • Clinical data for MDR/IVDR make it easy with real world Approach

    8 September 2021 EU MDR
    We all know that EU MDR and IVDR are clinical data hungry. When the assessment shows that you need ...