As medical device quality assurance and regulatory affairs professionals, it can be challenging to stay on top of changes happening in our industry. Few people have the time to read lengthy articles these days and although many online newsletters exist, they are often packed with PR releases, ads or unrelated information. That is why we started this blog for QA/RA professionals in the medical device and IVD industry. The idea is to give you short updates on quality and regulatory topics that may be of interest to you.

2011年 5月 27日

AdvaMed’s Reform Arguments Undermined by its Actions in 1997

Recent investigative reports from The Chicago Tribune call into question US medical device industry arguments...
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2011年 6月 3日

FDA Issues Advisory on Medical Device Components Imported from Japan

The US FDA’s Center for Devices and Radiological Health (CDRH) and Center for Biologics Evaluation and Research (CBER) have issued a notice warning of possible effects the ongoing nuclear disaster in Japan may have on medical device components exported to the US.
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2011年 6月 7日

EU Council Backs Current MedTech Legal Framework

The European Union’s Employment, Social Policy, Health and Consumer Affairs Council has issued
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2011年 6月 8日

FDA Inspections Database Now Live

The US Food and Drug Administration’s database of publicly available inspection information has officially launched. The Inspections Database provides information on the compliance status of regulated firms and facilities that must comply with the Food, Drug and Cosmetic Act. Inspection data is classified according to individual firms’ compliance status. Inspection results, from least to most serious, are indicated either as No Action Indicated (NAI), Voluntary Action Indicated (VAI) or Official Action Indicated (OAI).
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2011年 6月 9日

VC Group Lobbies for Reforms to US Medical Device Review Process

The Medical Device Venture Council, an informal group of venture capitalist firms focused on life sciences investing, has undertaken efforts to convince US lawmakers and Obama Administration offici
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2011年 6月 10日

Health Canada’s Surveillance Process Found Lacking

Canada’s Office of the Auditor General has found Health Canada’s medical device surveillance and inspection...
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2011年 6月 10日

Ontario Government Backs Off Requiring ESA Registration for Some Medical Device Makers

Last month, Ontario’s Ministry of Consumer Services issued a proposed amendment to the province’s product...
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2011年 6月 13日

Draft Guidance from FDA on Regulation of Nanotechnology

Draft guidance issued June 9 th by the US Food and Drug Administration lays out possible reg
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2011年 6月 13日

Japanese Trade Groups Urge Creation of Pan-Asian MedTech Community

The Japan Federation of Medical Device Associations (JFMDA) and the Medical Engineering Technology Industrial Strategy consortium (METIS), Japan’s two largest medical device and technology tr
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2011年 6月 14日

FDA Proposes CDRH Restructuring, Bigger Budget to Meet MDUFA III Requirements

The US Food and Drug Administration (FDA) has floated the possibility of reorganizing the Center for Devices and Radiological Health (CDRH) and providing more resources to the branch in order to ad
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