is being presented by Leo Eisner, Product Safety & Regulatory Consultant, with Eisner Safety Consultants and airs on Thursday, March 4, 2010. For more details or to register, please visit our site at www.fxconferences.com
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.
