Intertek Supports Medical Device Manufacturers with In-Depth Expertise
06 Apr 2011
Presentations and seminars in Boston area provide updates on the latest regulations
Intertek, a leading international provider of auditing and certification services, is dedicated to keeping medical device manufacturers updated on the latest quality management and regulatory requirements. This month, the company will be speaking at a Boston-area quality conference, and is also presenting a training course on market entry requirements for the European Union (EU).
Two of Intertek's medical industry experts will be speaking at BOSCON 2011, the annual conference of the Boston section of the American Society for Quality (ASQ).
On the morning of Tuesday, April 12, Alexander Crosby, an Intertek lead auditor, will speak about "Auditing Risk Management Systems." Mr. Crosby will show the audience what third-party auditors look for in terms of compliance with the risk management requirements of the ISO 14971 and ISO 13485 standards.
On the afternoon of Tuesday, April 12, Ron Nash, technical manager for Intertek's UK-based Notified Body, will speak on "Technical Files for MDD Compliance and the Impact of the 2007/47/EC Amendment." In particular, Mr. Nash will discuss the design process in generating the required data for a Technical File, and will outline the new standards and guidance documents that are applicable.
For more information on BOSCON 2011, or to register, visit www.asqboston.org/BOSCON.
Intertek is also proud to present its training course, "CE Marking for Medical Devices," in the Boston area on Wednesday, April 13. This interactive, hands-on workshop will provide attendees with practical information on the EU regulatory system and how to secure necessary certifications required for market entry. Attendees will learn about device classification, quality management system requirements, Technical File requirements, and more.
Learn more about "CE Marking for Medical Devices", management systems training, and other Intertek training courses.
Contacts
For further information, please contact:
Stacey Corbin
Global Marketing Manager, Systems Certification
Telephone: +1 978 929 2116
E-Mail: stacey.corbin@intertek.com
About Intertek
Intertek 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 27,000 people in more than 100 countries around the world. Visit www.intertek.com.