• 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 ...
  • TGA’s Reclassification of Medical devices around the corner. Ready?

    24 June 2021 EU MDR
    The New Reclassification system for medical devices is round the corner to its effective date (25 ...
  • Revised Chinese Medical Device Regulations by NMPA

    9 June 2021 EU MDR
    On 18Mar2021, from NMPA published the final version of "Regulations on the Supervision and ...
  • PMS & Risk Management in EU MDR

    7 May 2021 EU MDR
    With May 2021 deadline approaching, central focus for all companies should be postmarket ...
  • EU MDR Implementation Extension – helps in Compliance Planning

    26 November 2020 EU MDR
    As the extended transition deadline 26 May 2021 is approaching, we should be ready for ensuring ...