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.)

• Develop a plan for your company to transition to the amended MDD.  You may need to make a hard decision to discontinue distribution of older or lower volume products rather than spend the time and resources to update the applicable technical files and design dossiers.
• Review Annex IX (Classification) definitions and rules, as there are modifications in this Annex, which can impact the classification of your product and the conformity assessment route.  Some of the changes include:

Read on…

Pre-Announcement of Gap Analysis  & Update Package for Medical Device Directive Amendment 2007/47/EC

The changes to the current EC Medical Device Directive (MDD) 93/42/EEC become mandatory on March 21, 2010.  All manufacturers of CE marked medical devices must be in compliance by that date.  Eisner Safety Consultants in conjunction with Roberts Consulting & Engineering is offering a package for device manufacturers to assist them in complying with the changes. Click here to pre-order the package.

This exciting new package will be available for sale on the Eisner Safety Consultants website starting September 30, 2009 for $249.00.  You can pre-order with a credit card or a Paypal account.  Once the product is available it will be sent to you.

Full details, including contents of CD package…

Standards & Regulations Update Service

Has your Notified Body or Quality System Registrar issued a non-conformance or commented that your Standards & Regulations Library is out of date or that you have not included a complete enough list of applicable standards and regulations that are applicable to your products?  If so, we have a service that can help.  Eisner Safety Consultants can set-up a system for you (including a quality system procedure), monitor for new standards that impact your product line(s), review your existing list of standards & regulations and provide recommendations to improve your process, and we can help you maintain your existing system on a regular basis (once or twice a year).  Please e-mail us at Leo@EisnerSafety.com to inquire about this service.

2009 Symposium of the IEEE Product Safety Engineering Society Medical Device Track

October 27, 2009, Toronto, Canada

Leo Eisner, of Eisner Safety Consultants and the Chair of the Medical Track for this Symposium, will be presenting a regulatory update on IEC 60601-1, 3rd edition at the 2009 IEEE Symposium on Product Safety Engineering Society.  This presentation will be part of a whole day track which will include speakers from the FDA, IEC TC 210 Convener (ISO 14971), experts on IEC 60601-1, human factors, etc. and will have two panel discussions as well.

How do I sign up & How much is it?: Cost for the one day track is $200 for IEEE members & $250 for non-members up til Sept 24.  Cost for the whole conference is $450 for IEEE members & $550 for non-members up til Sept 24.  Note there are discounted rates for Life Time Members, Students, Spouses, Children & Guests of a full paying member or non-member. Register online.

Full details, including “Who should attend” and “Why you need this training”