Medical Development Group Announces Oct 3rd Forum “CE Mark - Global Market Access and US Perspective”
Medical devices are required to be CE-marked to be sold within Europe. This forum will give a clear and concise introduction on the essential requirements, choosing a conformity assessment route suitable for the medical device and your business setting, details on addressing a technical file, as well as real-world examples of success from the field.
Waltham, MA, September 24, 2012 --(PR.com)-- The Medical Development Group announces its Wednesday, October 3, 2012 Forum entitled “CE Mark - Global Market Access and US Perspective.” Medical device companies today look to Europe and the rest of the world to increase sales, grow market-share, and to ensure the benefits of their technologies and innovations are utilized on a global scale. Medical devices are required to be CE-marked to be sold within Europe. Medical Device Directive 93/42/EEC has defined the essential requirements to be met by medical device manufacturers. This forum will give a clear and concise introduction on the essential requirements, choosing a conformity assessment route suitable for the medical device and your business setting, details on addressing a technical file, as well as real-world examples of success from the field. According to MDG President Richard (Dick) O’Brien, "Importantly, several MDG members and fellow Massachusetts medical device entrepreneurs are considering launching products using CE marking approval. This is a very ambitious and timely program for our members and partners!"
Speakers: Christine Forcier, Intertek Business Assurance Program Manager for the medical and cosmetics sectors in North America.
Nigel Wilkinson, Senior Vice President, Quality Assurance for Smith & Nephew.
Enrico Perfler, Medical Device Technology Director for Eudax s.r.l., Pavia, Italy.
Moderator: David Pierson is a partner with Foley Hoag LLP where he chairs the firm’s Venture Capital/Emerging Companies Practice Group, representing emerging companies such as life sciences, medical device, cleantech, software and technology industries.
Who Should Attend:
For those who are in the medical device industry with a need to understand the EU regulatory requirements and processes, such as:
Regulatory professionals
R&D engineers
Project leaders and managers, risk management specialists
Professionals in QA and QM
Marketing and sales professionals
Senior managers
Benefits of Attending:
Learn the requirements for CE Marking devices
Hear up-to-date information on directives and CE Mark processes
See how standards fit into the technical documentation.
Determine the best route to conformity
Prevent delays during the approval process
Stay ahead of or keep up with your competitors
Understand the relationship between CE Marking and ISO 13485
Link to event details: MDG Wednesday, Oct 3, 2012 Forum begins 5:30pm – http://www.meddevgroup.org/
Registration Fee: Members: $25 (prepaid), $35 at the door.
Nonmembers: $35 (prepaid); $45 at the door. Cutoff for preregistration is 8 PM the evening before the event.
Location: Foley Hoag Emerging Enterprise Center, Bay Colony Corporate Center, 1000 Winter Street, Suite 4000, North Entrance, Waltham, Massachusetts 02451-1436 See event link for directions: http://www.meddevgroup.org/. Contact: info@meddevgroup.org
About The Medical Development Group
Medical Development Group (www.meddevgroup.org) is virtually headquartered in Massachusetts and serves the entire New England region. The Medical Development Group (MDG) is a community of individuals professionally committed to the Medical Device and other Medical Technology Industry segments united by the belief that innovation and advances in technology lead to substantial improvements in health care.
Contact: Judy Isaacson
Tel. 401-461-8059
E-mail: judy@vitalnow.net
Speakers: Christine Forcier, Intertek Business Assurance Program Manager for the medical and cosmetics sectors in North America.
Nigel Wilkinson, Senior Vice President, Quality Assurance for Smith & Nephew.
Enrico Perfler, Medical Device Technology Director for Eudax s.r.l., Pavia, Italy.
Moderator: David Pierson is a partner with Foley Hoag LLP where he chairs the firm’s Venture Capital/Emerging Companies Practice Group, representing emerging companies such as life sciences, medical device, cleantech, software and technology industries.
Who Should Attend:
For those who are in the medical device industry with a need to understand the EU regulatory requirements and processes, such as:
Regulatory professionals
R&D engineers
Project leaders and managers, risk management specialists
Professionals in QA and QM
Marketing and sales professionals
Senior managers
Benefits of Attending:
Learn the requirements for CE Marking devices
Hear up-to-date information on directives and CE Mark processes
See how standards fit into the technical documentation.
Determine the best route to conformity
Prevent delays during the approval process
Stay ahead of or keep up with your competitors
Understand the relationship between CE Marking and ISO 13485
Link to event details: MDG Wednesday, Oct 3, 2012 Forum begins 5:30pm – http://www.meddevgroup.org/
Registration Fee: Members: $25 (prepaid), $35 at the door.
Nonmembers: $35 (prepaid); $45 at the door. Cutoff for preregistration is 8 PM the evening before the event.
Location: Foley Hoag Emerging Enterprise Center, Bay Colony Corporate Center, 1000 Winter Street, Suite 4000, North Entrance, Waltham, Massachusetts 02451-1436 See event link for directions: http://www.meddevgroup.org/. Contact: info@meddevgroup.org
About The Medical Development Group
Medical Development Group (www.meddevgroup.org) is virtually headquartered in Massachusetts and serves the entire New England region. The Medical Development Group (MDG) is a community of individuals professionally committed to the Medical Device and other Medical Technology Industry segments united by the belief that innovation and advances in technology lead to substantial improvements in health care.
Contact: Judy Isaacson
Tel. 401-461-8059
E-mail: judy@vitalnow.net
Contact
Medical Development Group
Craig Lazinsky
603.560.1871
www.meddevgroup.org/
Judy Isaacson
Tel. 401-461-8059
E-mail: judy@vitalnow.net
Craig Lazinsky
603.560.1871
www.meddevgroup.org/
Judy Isaacson
Tel. 401-461-8059
E-mail: judy@vitalnow.net
Contact
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