• 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 ...
  • PMS Planning and Challenges under EU MDR

    15 October 2020 EU MDR
    While Post Market Surveillance (PMS) is mentioned in Annex X of the existing Medical Device ...
  • UDI : FDA versus EU with CND

    24 September 2020 EU MDR
    With increasing concerns for patient safety and efficient supply chain management, a single, ...
  • ISO 14971:2019 – Updates & older Version Differences

    27 May 2020 EU MDR
    The third edition of ISO 14971 was finally released in December 2019 and it replaces ISO ...
  • FDA/EU/MHRA/TGA suggestions for ongoing clinical studies

    8 April 2020 EU MDR
    There are several suggestions, recommendations from different health authorities for manufacturers ...
  • Real-World Approach in Collecting Clinical Data for MDR & IVDR

    6 April 2020 EU MDR
    The deadline for MDR is drawing near and for IVDR too there is not much time. In such a situation, ...