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 10日

Updated OJEC Standards & Recast of the Medical Devices Directive

As usual, the only thing that stays the same in the EU regulatory system is constant change, and this summer has been no exception.
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2011年 10月 11日

GHTF Proposes Harmonized Conformity Assessment System

The Global Harmonization Task Force (GHTF) is seeking comment on a recently issued proposal to establish a global conformity assessment system with uniform obligations for medical device manufacturers and regulators from market to market.
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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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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 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 18日

Mexico to Introduce New Class for Low-risk Medical Devices

Mexican medical device regulator COFEPRIS plans to establish a new device category, Class 1A, for...
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2011年 10月 18日

FDA Plans Reclassifying External Pacemaker Pulse Generators to Class II

The US Food and Drug Administration may reclassify external pacemaker pulse generators fr
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2011年 10月 18日

Indian Regulators to Expand Coverage of Medical Devices

Following recent meeting of India’s Drug Technical Advisory Board and Drug Consultative Committee, proposals to expand the list of Notified medical devices requiring
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2011年 10月 14日

US Senate Bill Targets FDA’s Device Review Process

US medical device industry lobbying efforts against current regulatory practices appear to be working.
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2011年 10月 13日

Eucomed Unveils Five-year EU Healthcare Strategy

European medical technology trade association Eucomed has published a five-year strategy for improving the EU healthcare system by more closely aligning medical technology with health care delivery and reimbursement models.
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