Be the first in the know. Join our devices expert Seamus Orr in Melbourne and Sydney for ISO 13485 : 2016 Training Course Some regulatory and standard version updates are anticlimactic – years of review and then the key changes are semantics that leave manufactures still pondering intent. This is not the case for ISO…
Medical Device Data Systems On the 9th February the FDA released the Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices (MDDS),’ Guidance for Industry and Food and Drug Administration Staff. The guidance document continues to reflect the FDA’s risk management approach around medical devices developed for patient self-monitoring. In June…
In October 2013, the Therapeutic Goods Administration (TGA) announced the launch of the Medical Device Single Audit Program (MDSAP) pilot from January 2014, together with Brazil’s Agência Nacional de Vigilância Sanitária (ANVISA), Health Canada, and the US Food and Drug Administration. On January 1, 2015, the MDSAP pilot program was opened to manufacturers around the…
Marketing medical devices at a global level can be a gruelling and onerous task when trying to achieve compliance to various differing regulations. FDA 21 CFR Part 820 compliance outlines Quality System Regulations for medical device manufacturers and importers. ISO 13485, a voluntary quality standard, provides a framework for meeting medical-device quality requirements in the…
The TGA has announced that it has signed an agreement to use the docuBridge® software solution to receive, review and process electronic applications for the entry of prescription medicines and other therapeutic products on to the Australian Register of Therapeutic Goods (ARTG).
This paper reviews the implementation of the ANSI/AAMI/IEC 62304 Medical Device Software – Software Life Cycle Processes standard.
The Therapeutic Goods Administration (TGA) launched the Medical Device Single Audit Program (MDSAP) pilot program, starting from January 2014, together with Brazil’s Agência Nacional de Vigilância Sanitária (ANVISA), Health Canada, and the US Food and Drug Administration (USFDA). The TGA and MDSAP participation The MDSAP is designed to ensure a single audit of a medical…
TGA REFORMS – HISTORICAL DOCUMENT (blog originally published 21 May 2013): The TGA has released an exposure draft of a Regulation Impact Statement (RIS) on proposed changes to premarket assessment requirements for medical devices. The RIS is in response to the earlier consultation document on device reforms, released in January. The RIS provides details on…
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