Australia – TGA – Actual and potential harm caused by medical software
Published in Australia, Software as Medical Device - SaMD and Therapeutic Goods Administration - TGA
More from AustraliaMore posts in Australia »
- Australia – TGA – 3-D printing (additive manufacturing) of medical devices
- TGA – Regulation impact statement: Proposed regulatory scheme for personalised medical devices, including 3D-printed devices
- TGA – Medical device application processing times
- TGA guidance – Researcher considerations for medical devices Meeting the evidence requirements for market authorisation
- Australia – New TGA Classification Rules for Software that is a Medical Device – IMPORTANT DATES
More from Software as Medical Device - SaMDMore posts in Software as Medical Device - SaMD »
- EU – MDCG 2020-1 Guidance on Clinical Evaluation (MDR) / Performance Evaluation (IVDR) of Medical Device Software
- Australia – New TGA Classification Rules for Software that is a Medical Device – IMPORTANT DATES
- TGA – Submissions received: Regulation of software, including Software as a Medical Device (SaMD)
- EU – Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 – IVDR
- US FDA Draft Guidance – Clinical Decision Support Software
More from Therapeutic Goods Administration - TGAMore posts in Therapeutic Goods Administration - TGA »
- Australia – TGA – 3-D printing (additive manufacturing) of medical devices
- TGA – Regulation impact statement: Proposed regulatory scheme for personalised medical devices, including 3D-printed devices
- TGA – Medical device application processing times
- TGA guidance – Researcher considerations for medical devices Meeting the evidence requirements for market authorisation
- Australia – New TGA Classification Rules for Software that is a Medical Device – IMPORTANT DATES
Be First to Comment