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 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 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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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 14日

FDA Clarifies IDE Approval Process

Through new guidance published this month, the US Food and Drug Administration has clarified its review and approval process for its Investigational Device Exemption (IDE) regulations , and has also proposed steps to allow clinical investigations of high-risk medical devices in some instances where IDE approvals have not been finalized.
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2011年 11月 14日

New FDA Guidance on IDEs for Early Feasibility Studies

The US Food and Drug Administration is proposing a new policy for Investigational Device Exemption (IDE) applications for
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2011年 11月 11日

Device Classification Guidance Issued by GHTF

As it transforms into a new organization , the Global Harmonization Task Force (GHTF) continues to issue guidances likely to influence major medical device regulators worldwide.
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2011年 11月 11日

Australia: License Cancellation for Non-Payment of Fees, ARTG Database

In September, the TGA released a response to the to the Australian Government Health Technology...
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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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