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Audio conference highlights

IEC 60601-1 is the cornerstone standard for medical electrical devices, yet development and adoption of the latest edition has been a long, complicated process. Three years after publication, there is still mass confusion over the ever-changing international and regulatory requirements impacted by the 3rd edition of IEC 60601-1. What is the best strategy for your company when it comes to designing your product to IEC 60601-1? Should you design to 2nd or 3rd edition, or both? The answer depends on where and when you will be selling your product!

In this audio conference, Leo Eisner provides a status update on IEC 60601-1 3rd edition, and discusses planned revisions, important regulatory dates related to the standard, and how the collateral and particular standards are aligned to 3rd edition. There are major changes from the 2nd edition, changes you need to know about in order to comply. Get the answers to your 60601-1 compliance questions from a leading expert!

This audio conference covers:

• Current changes to the 3rd edition of IEC 60601-1 including corrigendum and an interpretation sheet
• Planned modifications to IEC 60601-1, 3rd edition
• How do the collateral and the particular standards align with 3rd edition?
• What is the status of national versions of the standard?
• When does the standard become a regulatory requirement for US, EU, Canada, and other countries?

About the speaker:

Leo Eisner leads Eisner Safety Consultants (www.eisnersafety.com) in its efforts to help medical device, IVD and high-tech device clients navigate international product safety; medical device quality systems & auditing; regulatory processes such as FDA 510(k)s, IDEs, & PMAs, CE marking and the Canadian Medical Device Regulations; risk management; and development of international product safety standards.

As a registered Professional Engineer in the Safety Engineering discipline, he has over 20 years experience in product safety. In his nine years with UL, he worked with a variety of product categories and then spent several years with TÜV Product Service, specializing in electrical medical products. He later joined Karl Storz Imaging as a Compliance Engineer and has been consulting independently for over 10 years. Leo is a member of RAPS, AAMI, ASQ and IEEE Product Safety Engineering Society and has co-authored numerous articles on IEC 60601-1 and medical device safety. He also serves on the editorial advisory board for the industry publication MD&DI. Leo is the convener of IEC SC 62D JWG9 (IEC/ISO 80601-2-58) and is a member of several US technical advisory groups including TC 62, SC 62A & SC 62D, all related to the IEC 60601 series of standards.

Who should attend?

• Compliance engineers
• Product safety engineers
• R&D engineers
• Quality engineers
• Manufacturing engineers
• Engineering management
• Regulatory affairs/quality assurance (RA/QA)
• RA/QA management
• Operations/manufacturing management