• IVD Clinical Performance Studies for FDA & EU

    2 June 2020 IVDR
    At present, the regulatory discussion pretty much focuses on MDR Regulation (EU) 2017/745 on ...
  • 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 ...
  • Proactive strategies for Devices to minimize disruption

    15 May 2020 LCM
    It is know that Medical devices have long as well as highly regulated life cycles. Most ...
  • IVDR requirements for SOFTWARE

    24 April 2020 IVDR
    Software fulfilling the definition of an in vitro diagnostic medical device falls under the In ...
  • 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, ...
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