Eisner Safety Consultants Launches New Website

Eisner Safety Consultants, a leading name in regulatory, quality system, and product safety consulting, proudly announces the launch of its revamped and improved website.

We have kept the website simple, attractive yet easier to navigate and user-friendly.  We have also added several new features including:

• a news blog focused on the medical & IVD industries with an emphasis on regulatory, product safety and quality systems issues (Subscribe to our RSS feed  to be updated as we add to the news blog)
• Updated resources on our Weblinks and Library pages
• The ability to sign-up for our newsletter service using the form in the upper left sidebar of any page on the site
  
• AdvaMed Smartbrief News (updated daily)
• Bookmarking and sharing services to your favorite services with the Bookmark button on each page or article
  

Note – this is the first issue of our new newsletter.  Some of you have been added from our old newsletter list, which was published sporadically and not for some time.  If you would like to unsubscribe, you may use the link at the end of this message, or simply reply to this message with your request to unsubscribe in the subject line.

• New ESC Website
• MD&DI article on IEC 60601-1 3rd edition
• MDD Amendment
• MDD Gap Analysis & Update Package
• Standards & Regulations Update Service
• 2009 IEEE PSES Symposium – Medical Track

Regulatory Strategies:  Third Edition of IEC 60601-1

–Published September 2009 in MD&DI

The article discusses when IEC 60601-1:2005 will be mandatory, including the US, EU, and Canadian National versions of the standard.  The article looks at the history of the development of the standard and why the implementation has taken so long.

Adapted from an article by our associate Christine Ruther

The changes (Amendment 2007/47/EC) to the current EC Medical Device Directive (MDD) 93/42/EEC become mandatory on March 21, 2010.  By March 21, 2010 all your distributed products must comply with the amended version of the MDD.  The Amendment also updates the Active Implantable Medical Device Directive and so the same date applies for that as well.  There is no grandfathering of products that will be distributed into Europe after March 20, 2010. Your installed base is not affected.

Here is a partial list of items of the changes to consider to help you comply with the revision to the MDD.  To make this process easier for you we have developed a new package that will help you thru this process too. (See the next article for details on this package.)