Nemko Aquires Lab to Access NRTL (US) Mark

View the press release on the NEMKO website.

Get $50 off by signing up for thru our website

Are You Ready for MDD Amendment Directive 2007/47/EC?

Wednesday Jan 27, 2010, 2:00pm – 3:00pm Eastern Time, 60 minutes

Get a $50 discount ($199 after discount) for this event by using the special promotion code AF2009EIS when you sign up at the FX conferences website

Audio conference highlights

Time is running out – ease your MDD compliance strategy stress with detailed guidance from Leo Eisner!

The revised MDD 93/42/EEC comes into effect on March 21, 2010 and the changes will impact all medical device manufacturers that CE mark their products or plan to do so in future. There is no transition date for the amendment 2007/47/EC and if you are not in line with these new requirements by the implementation date, you could lose your CE mark certificate from your notified body.

In this audio conference, Leo Eisner provides an overview of the changes to the MDD, including: changes to definitions, the essential requirements, technical documentation requirements, classification rules, labeling requirements, and new requirements for usability (user error) and clinical data. The presentation also covers how the New Machinery Directive and the Personal Protective Device Directive work in concert with the MDD Amendment.

This audio conference covers:

• Major areas of change in the amended Medical Device Directive
• The drivers for this change
• Things your notified body may ask for during an audit
• Determining what areas of your system may be impacted
• The interplay between the revised MDD and other EU directives

Who should attend?

• Regulatory Affairs
• Quality Assurance
• Operations/Manufacturing
• Managing Directors
• Senior Management

Sign-up for the audio conference right here and use promo code AF2009EIS for a $50 discount on this event only

The old UL standards for Medical Devices & X-ray devices have been withdrawn as of December 21, 2009

Yes, it is true these old standards finally have been withdrawn.  UL’s announcement on December 21, 2009 stated “UL announces the withdrawal of the seventh edition of the Standard for X-Ray Equipment, UL 187, and the fourth edition of the Standard for Medical and Dental Equipment, UL 544, and their replacement with the first edition of the Standard for Medical Electrical Equipment, Part 1: General Requirements for Safety, UL 60601-1.”

MDT Article on Isolating USB Connections in Medical Devices

Medical Device Technology article in the Nov/Dec ‘09 publication of MDT on a new single component isolation device for USB for medical device application. Continue reading USB Isolation Solution for Medical Devices

ESC Newsletter #3 – Just Released

This issue we are going to focus on the 60601-1 series of standards based on the 3^rd edition of 60601-1 and the MDD & AIMDD, including the Amendment 2007/47/EC for the MDD.  First we are presenting an audio conference on the Marking and Labeling requirements for IEC 60601-1 which will be on November 18^th.  Please come and join in the audio conference.  Next we summarize the issues discussed on the CENELEC FAQ web page dealing with EN 60601-1, 3^rdedition questions that apply to the MDD and AIMDD.  Then we discuss the big changes coming down the line for the draft EMC Standards IEC 60601-1-2, 4^th edition & the new IEC 6XXXX, 1^stedition.  This is a must read article for any electrical medical device manufacturer.  Lastly, we remind you that there are less than 5 months left til the MDD Amendment requirements come into play.  One way to deal with this is to use our MDD Amendment Toolkit, which is only $249.00.

We hope you enjoy the third edition of our newsletter and we would enjoy hearing back from you on any suggested topics and your feedback.

To see past editions of the newsletter go to www.EisnerSafety.com/esc-news/. Subscribe to the newsletter to get future newsletters.  Go to any page on the website and enter your e-mail address in the upper left side of the webpage where it says “Sign-Up to our Newsletter”.