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 1月 25日

FDA Intends to Require PMAs for Some Defibrillator Products

Manufacturers of automated external defibrillators (AEDs) will likely have to begin submitting premarket approval (PMA) applications for their products in the US based on rumblings at the Food and Dru
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2011年 1月 21日

European Union Regulatory Update

The European Union’s regulatory community appears to be a flurry of activity with new MEDDEV guidance, updated standards lists, and a newly released roadmap for the much anticipated recast.
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2011年 1月 21日

Report: US Reimbursement System Hinders Novel Diagnostics Development

The current US reimbursement system has slowed development and adoption of novel diagnostic devices ,...
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2011年 1月 20日

CDRH Rolls Out 2011 Priorities

On the heels of revealing some of its 510(k) reform plans on January 19, the...
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2011年 1月 19日

FDA Reveals Some of its 510(k) Reforms

The US Food and Drug Administration (FDA) has rolled out the 510(k) premarket notification process...
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2011年 1月 19日

FDA Unveils Some Elements of 510(k) Overhaul, Postpones Hot-button Issues

The US Food and Drug Administration (FDA) has rolled out some — but not all — long-awaited changes to its 510(k) premarket notification process for clearing moderate-risk medical devices.
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2011年 1月 17日

POC Device Market Doubled in Six Years

According to new research from Kalorama Information, the point-of-care testing market reached $13.3 billion worldwide...
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2011年 1月 14日

FDA Issues Draft Guidance on Electronic Documentation

The US Food and Drug Administration (FDA) has recently published a draft guidance, “Electronic Source...
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2011年 1月 12日

Brazil: New Reimbursement System in the Works

The Brazilian National Congress’s Committee on Constitution and Justice and Citizenship has approved the incorporation of medical treatments and equipment into new reimbursement rules under the countr
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2011年 1月 11日

Single Medical Research Regulatory Framework Championed in the UK

The UK’s Academy of Medical Sciences has issued a new report recommending the consolidation of medical research regulations and governance under a single entity. The Academy’s report, “A new Pathway for the Regulation and Governance of Health Research,” includes five key components:
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