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 10月 24日

US Device Manufacturers Feeling Price Pressure from Hospitals

Medical device manufacturers in the US market are reporting mounting pressure to lower product prices as clients such as hospital groups seek to lower procurement costs and stem operating losses. According to a survey by hospital group purchasing organization Premier Inc. (via Dow Jones Newswire), hospitals have lost more than $1 billion due to high-cost medical devices and have indicated interest in purchasing lower-cost alternative products in the future.
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2011年 10月 26日

HC Extends Premarket Review E-Submission Program to Class III Devices

Starting November 1, 2011, Health Canada will extend a pilot program requiring both p
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2011年 11月 10日

Comment Period Extended for FDA’s Guidance on 510(k) Device Modifications

The US Food and Drug Administration has extended its comment period to November 28, 2011 for guidance the agency issued
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2011年 11月 7日

Drug and Medical Device Modernization Law Nearing Adoption in France

Two versions of a draft law amending regulations of pharmaceutical and medical technology products in France have been adopted by the French National Assembly and Senate.
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2011年 11月 7日

GHTF Unveils Successor Organization

The Global Harmonization Task Force (GHTF) will evolve into the International Medical Device Regulators' Forum (IMDRF) , with the new organization’s inaugural meeting set to take place in Singapore in early 2012.
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2011年 11月 3日

Push for Med-tech Innovation Policy Underway in Germany

The German government has formed a committee of industry and regulatory experts charged with developing a national innovation policy for medical technology.
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2011年 11月 2日

FDA Seeks Feedback on Device Labeling Requirements

The US Food and Drug Administration (FDA) has requested public comment from health care providers until January 3, 2012 on its proposed
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2011年 11月 1日

New DCGI director for India

Dr. V. G. Somani has been named Drug Controller General of India (DCGI) as of October 31, 2011.
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2011年 11月 1日

PMA Summary Review Database Now Available from CDRH

The US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) has launched a new searc
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2011年 10月 26日

Venture Capitalists Lobbying Congress Heavily to Reign in FDA

Venture capitalists are spending significantly on efforts to lobby the US Congress to ease FDA regulatory requirements for medical device manufacturers, to considerable effect. According to a New York Times report, venture capital funds allocating to medical device and technology manufacturers have provided more than $3.3 million in political donations to lawmakers and political action committees over the past five years.
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