SBS - The best value in QMS software

Informational TGA – Guidance on Therapeutic Goods (Conformity Assessment Standard for Quality Management Systems) Order 2019

Elsmar Forum Sponsor
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
M Informational TGA – Medical device cyber security guidance for industry Medical Device and FDA Regulations and Standards News 0
S Australia TGA Clinical Evaluation Report (CER) Other Medical Device Regulations World-Wide 0
E In need of a new TGA sponsor - Small software company Other Medical Device Regulations World-Wide 4
M Informational TGA – Submissions received: Regulation of software, including Software as a Medical Device (SaMD) Medical Device and FDA Regulations and Standards News 1
M Informational TGA presentation: Cybersecurity for medical devices Medical Device and FDA Regulations and Standards News 0
M Informational TGA presentation: How to submit an effective good manufacturing practice clearance application Medical Device and FDA Regulations and Standards News 0
M Informational TGA-led IMDRF Personalised Medical Devices working group meets in Canberra Medical Device and FDA Regulations and Standards News 0
M Informational TGA – Current status of breast implant products in Australia Medical Device and FDA Regulations and Standards News 0
M Informational TGA Consultation: Review of the regulation of certain self-testing IVDs in Australia Medical Device and FDA Regulations and Standards News 0
M Informational Australia – TGA business plan 2019-20 Medical Device and FDA Regulations and Standards News 0
M Informational TGA – Australian regulatory action on breast implants and breast tissue expanders Medical Device and FDA Regulations and Standards News 0
M Informational TGA – Essential principles checklist (medical devices) Medical Device and FDA Regulations and Standards News 2
M Informational TGA – Webinar: The cybersecurity of medical devices Medical Device and FDA Regulations and Standards News 0
M Informational TGA Consultation: Proposed clarification of the regulatory requirements for medical device systems and procedure packs Medical Device and FDA Regulations and Standards News 2
M Informational TGA Consultation: Proposed changes to medical device essential principles for safety and performance Medical Device and FDA Regulations and Standards News 0
M Informational TGA – Medical device incident reporting (MDIR) guide Medical Device and FDA Regulations and Standards News 0
M Informational TGA Webinar: Essential Principles to software Medical Device and FDA Regulations and Standards News 0
M Informational TGA – Medical device patient information leaflets and implant cards Medical Device and FDA Regulations and Standards News 0
M Informational TGA – European implementation of Medical Device and IVD Regulations – Implications for Australia Medical Device and FDA Regulations and Standards News 0
M Informational TGA – Advertising health products: Rules about safety claims in advertising Medical Device and FDA Regulations and Standards News 0
M Informational TGA presentation: Digital Devices Webinar 3, 20 June 2019 Medical Device and FDA Regulations and Standards News 0
M Informational TGA – Medical device annual reporting – Sponsor obligations Medical Device and FDA Regulations and Standards News 0
M Informational TGA – Webinar: An update on the consultation for the Regulation of Software, including Software as a Medical Device (SaMD) Medical Device and FDA Regulations and Standards News 0
J Australian TGA Sponsor costs Other Medical Device Regulations World-Wide 3
M Informational TGA presentation: How the TGA regulates software, 7 March 2019 Medical Device and FDA Regulations and Standards News 0
M Informational TGA – Action Plan for Medical Devices Medical Device and FDA Regulations and Standards News 0
M Informational TGA – Q&A: Use of market authorisation evidence from comparable overseas regulatory bodies for medical devices Medical Device and FDA Regulations and Standards News 0
C Sponsor Agreement Requirements for Australia TGA Other Medical Device Regulations World-Wide 7
A Australia TGA Medical Device Sponsor Agreement - Example or Template Other Medical Device Regulations World-Wide 18
M Informational TGA – Several proposed changes to classification to better align with the EU MDR Medical Device and FDA Regulations and Standards News 0
M Informational TGA – Brexit – Implications for therapeutic goods in Australia Medical Device and FDA Regulations and Standards News 0
M Informational TGA Consultation: Proposed regulatory scheme for personalised medical devices, including 3D-printed devices Medical Device and FDA Regulations and Standards News 0
M Informational TGA Consultation: Regulation of software, including Software as a Medical Device (SaMD) Medical Device and FDA Regulations and Standards News 0
M Medical Device News TGA Consultation: Good Clinical Practice Inspections Program Medical Device and FDA Regulations and Standards News 0
M Informational Webinar: The role of the TGA in digital health Medical Device and FDA Regulations and Standards News 0
M Medical Device News TGA Consultation: Potential reclassification of active medical devices for diagnosis and patient therapy Medical Device and FDA Regulations and Standards News 0
M Medical Device News TGA Consultation: Changes to a number of definitions and the scope of the medical device regulatory framework in Australia Medical Device and FDA Regulations and Standards News 0
M Medical Device News TGA – Regulator Performance Framework: Self-assessment Report, July 2017 to June 2018 Medical Device and FDA Regulations and Standards News 0
M Medical Device News TGA – Regulation of Software as a Medical Device Medical Device and FDA Regulations and Standards News 0
M Medical Device News TGA update 26-09-18 - Medical Devices Safety Update, Volume 6 September 2018 Other Medical Device Regulations World-Wide 0
M TGA comparable overseas regulators requirements matrix? Other Medical Device Regulations World-Wide 0
M TGA Disinfectant Wipes Registration Registrars and Notified Bodies 2
S Question about Australia - TGA and MDSAP - Technical file ISO 13485:2016 - Medical Device Quality Management Systems 3
S TGA regulations and ISO 13485:2016 gap analysis MDSAP ISO 13485:2016 - Medical Device Quality Management Systems 2
N MRA EU-TGA Product Registration to EU Market EU Medical Device Regulations 1
F Looking for Australian Sponsor for an impending TGA Submission Other Medical Device Regulations World-Wide 8
V Study About Raw Materials (Polymers) - DSC, FTIR,TGA, and SEM Images Inspection, Prints (Drawings), Testing, Sampling and Related Topics 8
M TGA Transition to ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 0
S Is TGA approval required for a ARTG listed IVD for a sample type addition? Other Medical Device Regulations World-Wide 11
N DEHP/DHP Labeling Requirements TGA Other Medical Device and Orthopedic Related Topics 2

Similar threads

Top Bottom