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.

2010年 11月 23日

Is my product a medical device?

There is no shortage of innovation in the medical device industry. Entrepreneurs and existing companies...
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2010年 11月 23日

Should you outsource some QA/RA functions? Pros and cons

If your company has ever tried to sell a new product in international markets such...
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2010年 11月 23日

Are European Bar Code Requirements on the Horizon?

Over the last several years, dialogue regarding medical device bar codes has cascaded throughout the industry.
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2010年 11月 23日

Europe Becomes More Vigilant About Vigilance

Under-reporting of incidents and general weaknesses in vigilance are no strangers to Europe's vast medical device regulatory landscape. In fact, this concept was addressed in this article.
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2010年 12月 2日

EU Regulatory Update - changes and pending revisions to regulatory guidance documents

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2010年 12月 2日

Changes to TGA Medical Device Applications & IVD Guidance Documents

There are modifications to TGA medical device applications, TGA's public regulatory consultation, and IVD guidance.
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2010年 12月 2日

Updates to medical device classification in Japan

As you may know, medical devices in Japan are classified as follows:
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2010年 12月 2日

Proposed Changes to Regulatory Approval Process in Mexico

On August 17, 2010, Mexico's President Felipe Calderon announced changes that will affect registration of medical devices in Mexico.
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2010年 12月 2日

FDA issues report on proposed objectives for CDRH's 510(k) program

A newly released FDA report has been made available for public comment until October 4, 2010.
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2010年 12月 2日

Important regulatory changes in Australia

IVDs will now be regulated by the TGA effective 1 July 2010. Though the Therapeutic Goods (Medical Devices) Amendment Regulations 2010 and the Therapeutic Goods Amendment Regulations 2010 were issued on 25 February 2010, the changes will be implemented on ...
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