Medical device incident reporting (MDIR) guide
Posts published in “Australia”
TGA Webinar: Essential Principles to software
Medical device patient information leaflets and implant cards
European implementation of Medical Device and IVD Regulations – Implications for Australia
Advertising health products: Rules about safety claims in advertising
TGA presentation: Digital Devices Webinar 3, 20 June 2019
TGA – Medical device cyber security guidance for industry
Guidance on Therapeutic Goods (Conformity Assessment Standard for Quality Management Systems) Order 2019
Medical device annual reporting – Sponsor obligations
Webinar: An update on the consultation for the Regulation of Software, including Software as a Medical Device (SaMD)