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Improved testing for medical devices

Medical device testing body TÜV Product Service is extending its testing service for active (powered) medical devices in the UK.

The new TÜV Active Medical Device Service includes safety testing for the first time, in response to demand from UK customers preparing for the 2012 edition of the Medical Electrical Equipment Standard.

The TÜV service has been designed to give UK manufacturers as much flexibility as possible. They can choose to use either an off-site testing service at TÜV's laboratories or an on-site service at the customer's site.

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."

The Active Medical Device Service covers any medical device that depends on electricity or any other applied source of power.

The new TÜV Active Medical Device Service will include: conformity assessment against the relevant directives; laboratory tests of safety and performance; assessment of safety-related issues and solution models; and assessment of functional safety and usability.

TÜV Product Service is the world's largest body for testing and certification of medical devices, with more than 1,000 customers globally.

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Medical device testing

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Recent comments (1)

  • mcanido

    Navigation is definitely a challenge. We recently held a workshop in Toronto, Ontario. An expert was invited to give a systematic overview of the EU regulatory system to small-to-medium size enterprises in the medtech space. Running your own company is challenging, let alone having to navigate regulatory systems. The speaker did a great job covering the system, and the attendees gained valuable take-home points. Presentation can be found at https://www.htx.ca/Resources.aspx under "HTX presentations".

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