• Are these findings observations in your CERs ?

    1 March 2021 CER
    Some companies finished their MED DEV R4 updates while some going through their NB reviews ...
    Read More
  •

    Is your Diagnostic State-of-Art?

    1 March 2021 IVDR
    Are you sure from IVDR perspective ? You being “SURE”, or your company thinks their ...
    Read More
  •

    Medical Devices – Regulatory Updates – February Volume 2

    18 February 2021 Regulatory Updates
    Europe | Thailand (FDA) EUROPE 1. Guidance on applying human factors to medical ...
    Read More
  •

    Medical Devices – Regulatory Updates – January Volume 1

    6 January 2021 Regulatory Updates
    Europe | US FDA | CANADA (HC) | Australia (TGA) | China (CMDE) | India (CDSCO) EUROPE 1. ...
    Read More
  •

    Medical Devices – Regulatory Updates December Volume 1

    3 December 2020 Regulatory Updates
    Europe | Australia (TGA) | Philippines (FDA) | China (CMDE) EUROPE 1. Converting ...
    Read More
  •

    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 ...
    Read More
    • 1 2 3 … 7
Close
The First Step

Let's talk about how MakroCare can help you