UL Public Seminars 2010        

Designing for Compliance to IEC 60601-1, 2nd Edition
Oct 5-6: Natick, MA
Oct 12-13: San Jose, CA
Nov. 9-10: Research Triangle Park, NC

This workshop is presented by experienced UL engineers who evaluate products for certification to U.S. and international standards for medical equipment. This two-day workshop will help you gain a thorough understanding of how to use IEC 60601-1 and UL 60601-1 effectively. Practice activities include:  analyzing a printed wiring board and verifying the construction components of a transformer to design specifications. A copy of the Standard is included with your workshop materials.

This one-day workshop, presented by experienced UL engineers who evaluate products for certification to U.S. and international standards for medical equipment, covers the changes that will be brought about by the issuance of 60601-1, 3rd Edition.  This workshop will help you gain a thorough understanding of how to prepare for those changes.

This workshop is intended to teach the principles and concepts of risk management as defined in ISO 14971. It provides a practical application that attendees will use as a model for applying risk management to their own situations.

Get the latest information on risk management concepts and practices for the medical device industry and learn how to plan your organization’s risk management and analysis program. Understanding risk analysis is essential to anyone in the medical device industry - this is a focus of the design control requirements in FDA’s Medical Device Quality System Regulation and ISO 14971: Application of Risk Management to Medical Devices.

Test, Measurement and Laboratory Use Equipment: Designing for Compliance to UL 61010-1
Oct. 6: Research Triangle Park, NC

This technical training workshop focuses on applying the "two levels of protection" concept, measuring creepage and clearance based on the voltages and materials involved, and selecting components of appropriate integrity for use in non-energy limiting circuits.

This newly designed two-day workshop will review product safety of information technology and communications equipment from the technical design perspective and in the context of accessing global markets with single equipment designs. Your experienced UL instructors will cover the based content of UL 60950-1, and all notable differences between the first and more recently published second editions.

This three-day workshop provides an overview of the requirements related to UL 1703 and IEC 61730. Participants will be able to identify the fundamental differences between the two standards.

The purpose of this two-day workshop is to increase your awareness of the safety issues involved with selecting plastic materials for use in electronic and electrical products. A series of lectures and classroom exercises have been designed to enhance your skills in selecting materials for specific product applications.

This workshop covers ISO/IEC 17025 requirements within the context of the Data Acceptance Program (DAP). Program participants will gain an understanding of how the 17025 standard serves as the foundation for DAP as well as specific Management and Technical Requirements. The workshop will also cover specific Data Recording and Reporting fundamentals including key data sheet components that must be adequately complete.

Learn how to assess compliance with ISO 9001:2000 and ISO 13485:2003 from the industry experts. Based on our ISO 9001:2000 RABQSA-certified IATCA QMS lead auditor training course, this interactive course covers the ISO 13485:2003 and ISO 9001:2000 requirements for quality management systems.

This two-day workshop will help you gain a thorough understanding of how to use IEC 60601-1 and UL 60601-1 effectively.

Learn how to assess compliance with ISO 9001:2000 and ISO 13485:2003 from the industry experts. Based on our ISO 9001:2000 RABQSA-certified IATCA QMS lead auditor training course, this interactive course covers the ISO 13485:2003 and ISO 9001:2000 requirements for quality management systems.

IEC 60601-1 3rd Edition:  Overview and Adoption Update

Cost - $99

This one-hour recorded webinar provides an overview of the changes between the 2nd edition of IEC 60601-1 and the 3rd Edition of IEC 60601-1 along with an update on the global regulatory adoption schedule. It includes significant discussion of the incorporation of risk management in the standard, and also provides an overview of the other areas in the standard that manufacturers will need to consider when designing medical devices to the 3rd edition.

Major Changes to the Medical Devices Directive 93/42/EEC as Amended by 2007/47/EC

Cost - $75

This one-hour on-demand webinar, recorded on December 3, 2009, is intended to provide an overview of the major changes to the Medical Devices Directive 93/42/EEC as amended by 2007/47/EC, which is mandatory March 21, 2010.

EU Directive 2007/47/EC is an amending directive and the changes documented within it are a significant update to the Medical Devices Directive 93/42/EEC and will impact all manufacturers that sell, or plan to sell, medical devices in Europe and potentially other countries of the world that currently recognize and accept CE marking as a means of market entry into their own territory. The changes become mandatory for manufacturers selling Medical Devices in the EU March 21, 2010.  This live webinar provides the opportunity to hear the Notified Body perspective on the major changes delivered from the UK by a senior Notified Body engineer at Underwriters Laboratories®.

Success with Multi-Site Audits Observations under Pharmaceutical Affairs Law in Japan

This thirty-minute on-demand webinar module is presented by Seiko Ohyama, lead auditor and primary reviewer for all Japan PAL technical files submitted through UL Japan for 3rd party review.  This course is designed to help companies put their medical devices on the Japanese market.

Risk Management for Medical Devices:  Compliance with ISO 14971

The one and a half-hour on-demand webinar will teach the purpose of risk management as required by the regulatory authorities around the world at a high level. It provides a practical application that attendees will use as a model for applying risk management to their own situation. This webinar is a prelude to IEC 60601-1, 3rd Edition that requires the application of ISO 14971 to the design and manufacture of a medical device.