SGS Organizes Learning Sessions across the US to Help Medical Device Industry Succeed In the Changing Global Regulatory Environment
(Rutherford, NJ, 29 August, 2013) – SGS, a leading Medical Devices Notified Body will arrange a series of events on 16-19 September to provide manufacturers across the country with an opportunity to meet some of the world’s leading medical device experts, discuss updates on the most acute topics and their implications to the industry.
The educational sessions offer insights to the changing European regulatory landscape for Medical Device companies, in-depth analysis of the challenges faced by the Class III manufacturers and an opportunity to learn how to successfully prepare and submit design dossiers and technical files. ‘As the regulatory bar in the industry is rising, our learning sessions offer a unique opportunity to help the medical devices manufacturers position themselves properly and ultimately, to find the fastest and the most reliable route to the market’, says Mindy McCann, Vice President of Healthcare at SGS North America.
Meet the SGS Class III expert team
The SGS team of experts will be available in all sessions for in-depth discussions:
Adrian Keene, Clinical Affairs & Regulatory Manager for Medical Devices: Adrian has more than 19 years experience in the Medical Device industry, including Smith & Nephew and Schering Agrochemicals and is a UK expert for ISO/TC 194 and an active participant in NB-MED and NBRG.
Alan Keller, Class III Medical Device Reviewer: Alan’s expertise is with cardiovascular devices. He conducts ECDE reviews for cardiovascular companies to the requirements of the MDD. Alan previously worked with BSI as a product expert for Class III general and vascular devices. Prior to that, he worked at Cook Incorporated in product development and regulatory roles as a Regulatory Scientist, Senior Engineer and Team Leader.
- Christopher Brodrick, Class III Medical Device Reviewer: Christopher has over 15 years of experience in the medical device industry. His expertise is in orthopedic devices, but also includes experience in cardiovascular stents, guidewires, catheters and combination devices (drug-eluting stents in particular). He conducts ECDE reviews for orthopedic companies to the requirements of the MDD. Christopher previously worked with Emergo Group as a principal consultant for CE marking and EU medical device regulations, prior to that Christopher was a senior technical reviewer conducting reviews of Class IIa, IIb and III technical files/design dossiers for clients seeking CE certification at BSI. Before that Christopher was with Guidant Corporation.
Four Sessions, Four Locations
The SGS Medical Devices 2013 Tour will include four complimentary evenings of conversation and learning:
- Boston, MA (Hilton Logan): September 16
- Minneapolis, MN (Embassy Suites Minneapolis North): September 17
- Dallas, TX (Omni Mandalay Dallas): September 18
- San Francisco, CA (JW Marriott Union Square): September 19
SGS has a global team dedicated to the specific needs of the medical device market, certifying medical device manufacturers in over 40 countries. As such, our experts can support you in the definition of the optimum audit and testing programme for your organisation, using our experience in the industry and benchmarking to best practices. With a presence in every single region around the globe, our people speak the language and understand the culture of the local market, and we operate globally in a consistent, reliable and effective manner.
For more details, please contact:
SGS North America
201 Route 17 North
Rutherford, NJ 07070
t: (201) 508-3081
SGS is the world’s leading inspection, verification, testing and certification company. SGS is recognized as the global benchmark for quality and integrity. With more than 75,000 employees, SGS operates a network of over 1,500 offices and laboratories around the world.