Medical e-News Round-Up - December 2011

This issue covers:

Software compliance: Get IT?

With the emergence of the Healthcare IT marketplace, and the regulations that come with it, manufacturers of equipment and medical device solutions will be required to apply a new approach to compliance.

Hardware compliance testing will still be required but, in addition, items such as risk management, software validation, solution reliability and interoperability will become embedded in the de facto language of conformity assessment.

That’s the view of Brian McAuliffe writing in the December issue of ‘In Compliance’ magazine about the CE marking of software. An interesting point of view? Read the complete article at

Arab spring for Rigel

The new UNI-PULSE defibrillator tester will be the star of Rigel’s stand at Arab Health 2012 (January 23 -26 Dubai International Convention and Exhibition Center). Visitors will also catch the new MULTI-FLO infusion pump analyser which comes out later this year

The move comes as the company continues to benefit from strong branding and a range of advanced value added products, which are spearheading growth and sales across the Middle East.

The compact, lightweight and portable UNI-PULSE defibrillator analyser will be launched in the Middle East at the show and features advanced measurement technology to verify the safe operation and functionality of all defibrillators. The battery powered analyser offers both manual and automatic test programs for testing of all mono-phasic, bi-phasic and pulsed waveform defibrillators.

John Backes, divisional manager for Rigel Medical, said: “We are committed to bringing innovative new products to market to meet customer requirements and we’re sure the many new features and benefits UNI-PULSE and MULTI-FLO offer will garner significant interest.”

Open to new ideas?

Medtronic has introduced Medtronic Eureka, a European web-based portal that helps physicians and medical technology inventors to bring their innovative ideas to life.

The move is designed to provide a single entry point where ideas can be submitted and evaluated by professionals. If the product is deemed not to be a fit for Medtronic, inventors can consent to allow the same idea to be evaluated by MD Start, an independent medical device incubator based in Switzerland.

“We are confident that an approach focused on Europe, which protects inventors and enhances opportunities to collaborate on innovation development, will yield excellent results and push medical technology forward,” said Dr. Stephen Oesterle, Medtronic Senior Vice President of Medicine and Technology.

Consumer group presses Congress for greater device oversight

In the US, the Consumers Union has urged Congress to strengthen the law that governs the approval of medical devices to ensure patients are not endangered by devices that haven't been thoroughly reviewed for safety.

The consumer group has called on Congress to improve medical device safety, instead of weakening approval process. It wants to ensure that all implantable and life-sustaining medical devices are subject to more rigorous review by the US Food and Drug Administration and to establish a better system for tracking devices after approval so patients and doctors can be better protected. Full story at

The future of EMC engineering

What EMC engineers face now will surely be the same in the future, except that the level of complexity will increase significantly. What is critical for success says ‘In Compliance’ magazine, is continuing education and networking and identifies six points for compliance engineers to consider. To find out what these are visit and turn to pages 24 – 25.

Under the microscope 

Carl Zeiss Ltd as part of the Carl Zeiss Group - a global market leader in precision optics and engineering technology - has specified the Rigel Medical 62353 medical safety analyser to comply with IEC 62353, the standard for in-service and after repair testing of medical electronic devices.

This move has led to improvements in the testing of hundreds of electrically powered operating microscopes and ophthalmic diagnostic devices which Carl Zeiss supplies and supports throughout the UK to the NHS trusts, private hospitals and high street optometrists.

Using the Rigel Medical 62353 provides a cost effective, versatile and highly portable testing solution, enabling Carl Zeiss service engineers to quickly and accurately check the safety of upwards of 300 different Zeiss products per week at dozens of locations throughout the UK.

Roy Scales, service manager at Carl Zeiss, said: “The Rigel Medical 62353 is a very good, highly reliable instrument which not only enables us to comply with the European standard but has definitely helped us ensure our products are safe to use.

“It’s intuitive, easy-to-use and compactness is appreciated by our engineers. It also incorporates a good range of features for a tester of its size, while the connectivity benefits are particularly impressive.”

IEC 60601 deadline approaches

A reminder that the transition period for the Third Edition of the medical electrical equipment standard (IEC 60601 – 1:2005) finishes this May.

So get ahead of the game. Start designing against this expanded standard now to avoid costly re-design further down the line and ensure your products can continue to be sold on the European market.

It would also be wise for end-users and purchasers in the medical laboratory environment to be aware of the requirements that suppliers of their products must now meet. One such requirement is the incorporation of the concept of ‘risk management’ and the requirement to keep a detailed Risk Management File (RMF). This is essential, as many of the tests are required to demonstrate compliance with the standard make reference to the RMF.



















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