Search Results for MDSAP

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MDSAP Update: Canada's 2019 Deadline Still on Track By Michael Mezher - Published 11 September 2017

Speaking at RAPS' 2017 Convergence on Monday, officials from two international regulators and representatives from auditing organizations offered the latest on the Medical Device Single Audit Program (MDSAP).

Categories: News, Japan, Canada, Latin America and Caribbean, Oceania, US, Anvisa, FDA, Health Canada, MHLW, PMDA, TGA, Medical Devices

Tags: MDSAP, Medical Device Single Audit Program

510(k) Third Party Review Program: FDA Offers New Draft Guidance By Zachary Brennan - Published 09 September 2016

The US Food and Drug Administration (FDA) on Friday issued new draft guidance updating the agency’s current thinking on a program used to accredit third parties to review premarket notification (510(k)) submissions for medical devices and recommend the initial classification of certain devices.

Categories: Canada, Europe, US, CDRH, Health Canada, IMDRF, MHLW, TGA, Government affairs, Manufacturing, Medical Devices, Research and development

Tags: 510(k) submissions, medical devices, third-party audits of medical devices, IMDRF, MDSAP

IMDRF Offers Progress Updates at March Meeting By Zachary Brennan - Published 01 April 2016

The ninth meeting of the management committee of the International Medical Device Regulators Forum (IMDRF) took place in Brasília, Brazil, from 8 to 10 March 2016 and included high-level updates on how the group’s seven current work items are progressing and how device regulations are continuing to converge at the international level.

Categories: News, Asia, Canada, Europe, Latin America and Caribbean, Oceania, US, Anvisa, EC, EMA, FDA, Health Canada, IMDRF, MHLW, PMDA, WHO, Clinical, Compliance, Due Diligence, Government affairs, Manufacturing, Medical Devices, Quality

Tags: IMDRF, medical device regulations, MDSAP, international medical device regulations, medical software

FDA Ends Voluntary Audit Pilot Ahead of 'Fully Operational' MDSAP By Michael Mezher - Published 18 December 2015

The US Food and Drug Administration (FDA) says it is discontinuing one of its audit-sharing pilots ahead of the launch of a "fully operational" Medical Device Single Audit Program (MDSAP) in 2017.

Categories: News, US, CDRH, GHTF, IMDRF, Audit, Medical Devices, Postmarket surveillance, Regulatory strategy

Tags: MDSAP, Medical Device Single Audit Program, ISO 13485, Kim Trautman

MDSAP to Continue Past Pilot Phase in 2016 By Zachary Brennan - Published 28 October 2015

Put simply, the Medical Device Single Audit Program (MDSAP) isn't going anywhere when its pilot project ends in 2016, Kim Trautman, associate director, international affairs of the Office of the Center Director of CDRH at the the US Food and Drug Administration (FDA), told attendees of RAPS' Regulatory Convergence on Wednesday.

Categories: News, Asia, Canada, Europe, Oceania, US, Anvisa, EC, FDA, GHTF, Health Canada, IMDRF, MHLW, PMDA, TGA, WHO, Audit, Government affairs, In vitro diagnostics, Manufacturing, Medical Devices, Postmarket surveillance, Regulatory intelligence

Tags: MDSAP, medical device single audit program, FDA pilot program, US FDA, TGA, PMDA

Medical Device Industry and Regulator Harmonization Efforts Update By Susan Hibbeln - Published 23 April 2014

As more countries formalize medical device regulations, international regulatory and quality systems professionals must continually refine and harmonize their internal processes for registration of medical device products and adherence to international quality standards.

Categories: Features, GHTF, IMDRF

Tags: RPS, MDSAP, harmonization, medical device

Brazil Expedites Device Imports By Louise Zornoza, RegLink - Published 15 April 2014

Categories: Regulatory Update, Anvisa

Tags: Medical Device Single Audit Program, MDSAP, CBPF, Import, brazil, cGMP, medical device

IMDRF Proposes Framework for Regulating Device Software, Auditing Organizations By Alexander Gaffney, RAC - Published 02 April 2014

Categories: IMDRF, Audit

Tags: SaMD, MDSAP, Software, Latest News, medical device