Complimentary Dallas 2013 Medical Device Tour Series: Risk for Medical Device Companies, The Bar is Rising, Are You Positioned Properly?
Sep 18, 2013, 18:00
Sep 18, 2013, 21:00
Dallas, United States
This unique event will give you updates on the most acute topics in the Medical Device Industry, helping you to get your products to the market faster and excel in satisfying your customers. You will have a chance to network with SGS international experts and learn about the changing European regulatory landscape for Medical Device companies. You will have a chance to meet and talk with our team concerning the challenges for Class III manufacturers and to learn how to successfully prepare and submit design dossiers and technical files.
The right Medical Device Certification at the right time is the key to winning new contracts, launching new products and entering new markets. That is why SGS offers Medical Device Manufacturers the most comprehensive services available - to get your products to market faster.
We will be discussing:
- The changing regulatory landscape in the EU
- Implementing the current 93/42/EEC directive
- Looking forward to the new regulations
- Current challenges for Class III manufacturers
- Clinical evaluation
- Clinical equivalence in the EU
- Post market clinical follow - up
- Making a successful design dossier submission
- Design dossier elements
- Preparing and presenting your design dossier
Food and drink will be provided
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 Eller, Class III Medical Device Reviewer
- 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. Alan’s expertise is with cardiovascular devices. He conducts ECDE reviews for cardiovascular companies to the requirements of the MDD.
Christopher Brodrick, Class III Medical Device Reviewer
- Christopher has over 15 years of experience in the medical device industry. 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.
- Christopher’s 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.
Omni Mandalay Hotel at Las Colinas, September 18th, 6-9pm
221 East Las Colinas Boulevard, Dallas (Irving), Texas, 75039
Minneapolis, Minnesota, United States
For further information, please contact:
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.