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 11月 14日

Stryker Announces Layoffs Ahead of Excise Tax

Medical device manufacturer Stryker Corporation is planning a five-percent workforc
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2011年 11月 22日

FDA Reopens Comment Period for Microbiology/Medical Countermeasure Device Evaluations

The US Food and Drug Administration is seeking further comment on its proposed approach for...
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2011年 11月 18日

FDA Panel Sets Meeting Date to Discuss CES Reclassification

The Neurological Devices Panel of the US Food and Drug Administration’s Medical Devices Advisory Committee will hold a public meeting on February 10, 2012 to consider
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2011年 11月 18日

FDA Seeking Comment on Device Recall Data Collection Policy

The US Food and Drug Administration is requesting comment on its information collection practices regarding medical device recall policies.
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2011年 11月 17日

US Consumer Group Urges Stronger Role for FDA

US consumer advocacy group Consumers Union is arguing that Congress strengthen the Food and Drug Administration's ability to regulate medical devices in order to improve quality, safety and effectiveness.
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2011年 11月 17日

European Regulatory Update: RAPS, EU "Recast"

Jacqueline Minor, Director of Consumer Affairs, DG SANCO, Health and Consumers, European Commission presented at...
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2011年 11月 17日

Mise à jour réglementaire européenne : SPAR, « Refonte » de l'UE

Nous vous informons d’une mise à jour sur la « Refonte » proposée de l'Union...
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2011年 11月 17日

Mises à jour réglementaires dans l’UE

Par la présente, nous vous communiquons les mises à jour de l'automne de l'Union européenne.
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2011年 11月 16日

EDMA Study: European IVD Market Stagnating

A new report examining European in vitro diagnostic (IVD) market performance in 2010 sees flat or negative growth across most major EU member states due to cost containment measures and worsening economic conditions. According to the European Diagnostic Manufacturers Association’s (EDMA) study, the European IVD market totaled €10.5 billion last year, with revenue growth of only two percent from 2009. Cardiology testing and diabetes-related IVD sectors as well as products for managing hospital-acquired infections showed the strongest growth rates in 2010, but all other testing areas showed flat or negative growth.
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2011年 11月 15日

FDA Seeking Comment on Device Reclassification Policy

Public comment is being requested through January 13, 2012 by the US Food and Drug Administration regarding data collection requirements for
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