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.

2009年 12月 21日

Update to EU medical device vigilance guidance

The European MEDDEV 2.12.1 entitled "Guidelines on a Medical Devices Vigilance System" has been revised.
2010年 1月 5日

Clinical Data Requirements & Guidance on Vigilance Revised

As you are well aware, Directive 2007/47/EC goes into effect March 21, 2010. This Directive will affect all medical devices (except IVDs) marketed in Europe.
2010年 1月 20日

New Version of European MEDDEV 2.7.1 on Clinical Evaluation Now Available

A revision of European guidance MEDDEV 2.7.1, entitled "Clinical Evaluation: A Guide for Manufacturers and Notified Bodies" was issued in December 2009.
2010年 1月 27日

PMDA Issues List of Pre-Market Certificates Issued by RCBs in Japan

The PMDA has just recently released a spreadsheet enumerating the pre-market certificates issued by each of the 12 Registered Certification Bodies (RCBs) sanctioned under the Pharmaceutical Affairs La
2010年 2月 1日

Brazil to require GMP compliance starting May 22

On May 22, 2010, ANVISA, the Brazilian Health Surveillance Agency, will require manufacturers of high risk equipment and materials (classes III and IV); as well as high risk IVD products (classes I
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...
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...
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.
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.
2010年 12月 2日

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