“Medical Compliance in a Box” provides insights and valuable information to manufacturers seeking market access in North America and the European Union”
Intertek, a leading global provider of quality and safety solutions, announces the availability of a unique two-day seminar for medical device manufacturers. Titled “Medical Compliance in a Box,” the seminar introduces manufacturers to the regulations and opportunities that occur throughout the medical device product life cycle, particularly for the North American and the European Union markets.
The seminar is presented in a fast-paced workshop format, designed to fully prepare attendees to identify key requirements, overcome challenges that apply to the business, and develop a “road map” to regulatory compliance. The instructors are industry-leading professionals with extensive experience in helping manufacturers bring medical devices to market.
The “Quality & Regulatory” module reviews how a Quality Management System may be used to demonstrate the manufacturer’s ability to provide medical devices that consistently meet customer and regulatory requirements. This module is presented by Christine Forcier, Intertek’s
Systems Certification program manager for the medical sector in North America.
The “FDA 510(k) Review” module will show attendees how to deliver their products to the U.S. market on schedule, with faster clearance from the FDA. This module is presented by Paula Wilkerson, a senior engineer at Intertek and a senior reviewer in the company’s third-party
510(K) review program.
The “Product Safety and Electromagnetic Compatibility” module will help attendees ensure that their devices pose no hazard to the patient or end user. This module is presented by Bob Burek, Intertek’s technical leader for electrical medical devices.
The “Product Performance” module will help attendees determine how well and how long a device will last, so they can pre-empt service issues and avoid performance-based recalls. This module is presented by Alex Porter, Intertek’s chief engineer for Programs, Performance and Durability.
Finally, the “Environmental Compliance” module will help attendees ensure their products’ compliance with restricted substance, waste disposal/recycling, energy usage, and other regulations. This module is presented by Tom Svoboda, the environmental programs development manager for Intertek’s Health and Environment group.
The “Medical Compliance in a Box” seminar will be held on Wednesday, September 22 and Thursday, September 23 at Intertek’s facility in Oakdale, MN. Tuition is $995 per person, which includes all course materials, lunches, and refreshment breaks. Attendees will also receive a certificate for 1.4 CEUs, credits which may be applied towards continuing education or training requirements
Attendees who register for the Oakdale seminar by Friday, September 3 will be offered an early-bird rate of $695 per person. Group discounts are available.
The seminar will also be held on November 3-4 in Menlo Park, CA.
For further information, or to register for the seminar, visit http://intertek.com/events/2010/medical-compliance-in-a-box/ or contact Roy Strunin at (978) 635-8558 or roy.strunin@intertek.com.
About Intertek
Intertek (ITRK.L) is a leading provider of quality and safety solutions serving a wide range of industries around the world. From auditing and inspection, to testing, quality assurance and certification, Intertek people are dedicated to adding value to customers’ products and processes, supporting their success in the global marketplace. Intertek has the expertise, resources and global reach to support its customers through its network of more than 1,000 laboratories and offices and over 25,000 people in more than 100 countries around the world. For more information, visit www.intertek.com.
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