• Medical Devices – Regulatory Updates – April Volume 2

    20 April 2021 Regulatory Updates
    Europe | New Zealand (MEDSAFE) | CHINA (NMPA) EUROPE 1. Commission Implementing ...
  • Medical Devices – Regulatory Updates- April Volume 1

    5 April 2021 Regulatory Updates
    USA (FDA) | EUROPE | Australia (TGA) | CHINA (CMDE) | Thailand (FDA) | Kazakhstan (NDDA) | ...
  • Medical Devices – Regulatory Updates- March Volume 2

    18 March 2021 Regulatory Updates
    Europe | CHINA(CMDE) | SINGAPORE (HSA) | AUSTRALIA (TGA) | KAZAKHSTAN (NDDA) ...
  • 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 ...
  • Is your Diagnostic State-of-Art?

    1 March 2021 IVDR
    Are you sure from IVDR perspective ? You being “SURE”, or your company thinks their ...
  • Medical Devices – Regulatory Updates – February Volume 2

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