Development and adoption of the IEC 60601-1 standard has been a long and complicated process. Four years after the standard was published, there remains much confusion. This audio conference takes a look at 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 and test to 2nd or 3rd edition, or both? That depends on when and where you plan to market your medical electrical product, whether you will be selling legacy products, and if there are significant changes expected in the future that may require retesting or resubmission to a national regulatory authority.

In this audio conference, 60601 expert Leo Eisner discusses the current status of IEC 60601-1 3rd edition, scheduled changes and important regulatory dates, and how the collateral and particular standards are aligned to 3rd edition. The presentation also covers points to consider when setting up a company transition strategy.

The third edition of this cornerstone standard for medical electrical devices has gone through major changes since 2nd edition. Ease your 60601-1 regulatory compliance strategy stress with detailed guidance 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 the collateral and particular standards align with 3rd edition
• The status of national versions of the standard
• When the standard will become a regulatory requirement for US, EU, Canada, and elsewhere
• Ideas to consider for setting up a company transition strategy from 2nd to 3rd edition

About the speaker:

Leo Eisner leads Eisner Safety Consultants 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 25 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 and has co-authored numerous articles on IEC 60601-1 and medical device safety. He is the convener of IEC SC 62D JWG9 (IEC/ISO 80601-2-58) and is a member of several IEC 62 technical advisory groups for the IEC 60601 series of standards.

Who should attend?

• Compliance and Product Safety Engineers
• Regulatory Affairs/Quality Assurance
• R&D and Quality Engineers
• Quality and Manufacturing Engineers
• Operations/Manufacturing Management
• Engineering Management