TÜV Product Service extends Active Medical Device Service in UK
Added: (Thu Oct 22 2009)
Pressbox (Press Release) -
TÜV Product Service, the world’s largest medical device notified body, is extending its UK-based active medical device testing service.
The TÜV Active Medical Device Service includes safety testing for the first time and is responding to a surge in demand from UK customers that are preparing for the 2012 third Edition of the Medical Electrical Equipment Standard (IEC 60601-1:2005). The new service will complement TÜV’s existing EMC and environmental testing performed at it UK laboratories and factory assessments carried out by its UK-based audit team.
The TÜV service has been designed to give UK manufacturers complete flexibility in how their products are tested. Manufacturers can therefore choose to use either an off-site service, where testing is conducted at TÜV’s laboratories, or an on-site service at the customer’s own site. This flexible approach will to help decrease time to market for products, while ensuring compliance and safety.
Jean-Louis Evans, Managing Director of TÜV Product Service said: “The manufacture and sale of medical devices is becoming increasingly difficult for our customers to navigate alone. The market is very competitive and constantly evolving with the introduction of new standards and legislation, both in the EU and globally. It is therefore proving essential for us to offer a service that is on-the-ground in the UK, to give our customers greater choice and a faster turnaround.
“As the deadline for 2012’s new Medical Electrical Equipment Standard looms, we are finding that many of our customers are concerned that test houses will be booked solid as the cut-off date approaches. We hope the new service will assuage those concerns and deliver a robust alternative to manufacturers in the active medical device sector,” concluded Evans.
The Active Medical Device Service will cover any medical equipment which depends on an electrical source or any source of power, other than that directly generated by the human body or gravity.
The new TÜV Active Medical Device Service will include:
•Conformity assessment against the relevant Medical Devices, Active Implantable Medical Devices or In Vitro Diagnostic Medical Devices Directives
•Performing of laboratory tests (electrical safety, mechanical safety, performance tests etc.) according to IEC 60601-1, IEC 60601-1-1 and selected part two standards
•Assessment of safety-related issues and of solution models
•Assessment of the functional safety of active medical devices (safety of hardware and software)
•Assessment of the usability of active medical devices
-ENDS-
About TÜV Product Service www.tuvps.co.uk
TÜV Product Service is one of the world’s leading experts on product testing with 170,000 product certifications in circulation globally. It is also the leader in the test and certification of medical devices, with more than 1,000 customers globally. With 13,000 employees worldwide, TÜV covers regulatory and voluntary aspects associated with satisfying legal and cultural requirements for products. It also helps retailers across the world to ensure a consistent supply chain by helping them to ensure safe, compliant and reliable products are put on the shelves.