• 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 ...
  • Device Label Externalizing or Outsourcing

    7 October 2020 Labeling
    If you are single product Device Company or single country multi-product company or a company ...
  • UDI : FDA versus EU with CND

    24 September 2020 EU MDR
    With increasing concerns for patient safety and efficient supply chain management, a single, ...
  • Medical Devices – Regulatory Updates – September Volume 2

    17 September 2020 Regulatory Updates
    Europe | US FDA | INDIA (DGFT) | Malaysia (MDA) EUROPE 1.MHRA: Regulating medical ...
  • Medical Devices – Regulatory Updates – September Volume 1

    3 September 2020 Regulatory Updates
    Europe | US FDA | CANADA (HC) | Australia (TGA) | INDIA (DGFT) | Philippines ...
  • Medical Devices – Regulatory Updates – August Volume 2

    19 August 2020 Regulatory Updates
    Europe | US FDA | INDIA (DGFT) EUROPE 1.Guidance for industry on MHRA’s expectations ...
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