• Post-Market Surveillance Planning and Challenges under EU MDR

    11 July 2019 EU MDR
    PMS is a collection of processes and activities used to monitor the performance of a medical ...
  • EUDAMED and EU Medical Device Nomenclature

    20 March 2019 EU MDR
    The European Commission explain the details of how a future system for medical device nomenclature ...
  • Use of Retrospective RWD for EU MDR Compliance

    12 March 2019 EU MDR
    As EU MDR has already entered into force and will be applicable in May 2020, the device companies ...
  • Med Device PMCF: How to get right Sample size

    5 March 2019 PMCF
    Post Marketing Clinical Follow (PMCF) is a continuous process to assess and analyze clinical data ...
  • Labeling findings from FDA and other Agencies audits summary

    1 March 2019 Labeling
    Regulatory environment has become increasingly complex and making drug labeling a highly ...
  • Effect of GDPR on Medical Devices in EU

    25 February 2019 EU MDR
    Growth of technology brought forth internet enabled Medical Devices which can help with everything ...
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