Navigating the approvals process for RF enabled medical devices

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This post is by Joe Lomako, Telecoms & Radio Business Development Manager, TRaC
 
RF technology is now being found in all manner of devices. One of the industries that's seeing an increased interest is the medical industry with radio devices being incorporated into a wide spectrum of devices from heart rate monitors and blood pressure meters to weighing scales. There is even a bed occupancy monitor!

These are all very important applications which make patient monitoring much more efficient and cost effective, particularly in an ageing population. ZigBee and Bluetooth technology are increasingly being recognised as premium technologies for these types of application. 

However, when the entrepreneur comes up with a brilliant idea for an RF enabled medical device, he is met with a minefield of approvals requirements. Once a radio is incorporated into another product, things get more complicated, as both the radio and product specific approvals requirements must be met (Radio, EMC, Safety, Certification and Qualification, Medical notified bodies).
 
This process becomes even more intricate when the number of target market countries increases. Of course the manufacturer can perform this process themselves, but usually they find it a (very!!) steep and expensive learning experience. Getting the right support to navigate the approvals process is essential if innovative ideas are to become reality.

Needless to say, at TRaC we have assisted many innovative companies to produce great products by determining exactly what the requirements are, performing the testing and managing the process end-to-end.

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Jonathan Harros, ZigBee Business Manager, TRaC
Jonathan Harros, ZigBee Business Manager, TRaCAfter obtaining his Bachelor's degree in engineering, Jonathan worked for a number of engineering companies prior to obtaining a teaching role at the University of Hull (England). In 1995 he joined KTL, an internationally renowned test laboratory which then became TRaC, as part of the Digital Group specialising in regulatory requirements for digital telecommunications equipment. During his time at the company he has, among other things, been appointed as Senior Protocol Engineer, and Approvals and Homologation Group Manager. Jonathan has actively participated in various technical working groups for the ZigBee Allianceâ and is currently the ZigBee Qualification Group (ZQG) Lead Technical Editor.

Steve Hayes, EMC & Safety Managing Director, TRaC
Steve Hayes, EMC & Safety Managing Director, TRaCSteve is Managing Director for the EMC and Safety business of TRaC and has been involved in EMC and product approvals for 19 years. In addition to the day to day running of the business, Steve is actively involved in EMC standardisation both in commercial and defence areas. In addition to being the UK Principal expert on EMC standardisation of Industrial, Scientific and Medical (ISM) products he is also the convenor of CISPR/B/WG1 who has the responsibility of writing the International standard, CISPR 11. Steve wrote the CE marking annex to the UK's defence EMC standard as well as being co-convenor of CENELEC TC210/WG9, responsible for writing a guide on approval of military systems with commercial (CE Marking) requirements.

Joe Lomako, Telecoms & Radio Business Development Manager, TRaC
Joe Lomako, Telecoms & Radio Business Development Manager, TRaCJoe Lomako MSc is the Business Development Manager of Telecoms and Radio at TRaC. He has been involved in the testing and compliance industry for over 15 years. Prior to joining TRaC Joe specialised in EMC, EMF Exposure and Radio compliance.

Chris Stone, Test Manager TRaC Environmental & Analysis
Chris Stone, Test Manager TRaC Environmental & AnalysisAppointed Test Manager in 2007, following three years as Projects Manager at TRaC, having previously worked as Head of Environmental Testing at another UKAS accredited test house. Over 20 years' experience of modelling, testing and measurement in the structural dynamics and seismic fields.

Chris Rouse, Safety Product Manager, TRaC
Chris Rouse, Safety Product Manager, TRaCChris has worked in electrical safety compliance for over 17 years. Having previously worked for BSI, he joined TRaC in 1996, progressing through a number of testing roles before becoming Safety Product Manager in 2006.

Graham Andrews, Analysis Commercial Manager, TRaC
Graham Andrews, Analysis Commercial Manager, TRaCAppointed Commercial Manager - Analysis in November 2009. Prior to joining TRaC, he was the Business Development Manager at Onward Technologies, an engineering services company based in India. Graham has spent over 20 years working in the CAD / CAE domain selling both engineering services and engineering systems.

Stephen Tait, Senior Telecoms Engineer, TRaC
Stephen Tait, Senior Telecoms Engineer, TRaCStephen Tait joined KTL, an internationally renowned test laboratory which then became TRaC, as part of the Telecom Group specialising in telecommunications product testing for worldwide approvals. Stephen is also responsible for the Telecoms commercial activities within the TRaC group.

Simon Barrowcliff BEng CEng MIET MBA, ATEX Director, TRaC
Simon Barrowcliff BEng CEng MIET MBA, ATEX DirectorSimon Barrowcliff is the Director of the ATEX Notified Body at TRaC. He set up TRaC's Lancashire-based, ATEX business in 2002 and has been heavily involved in EX testing and compliance since then. Simon also runs TRaC's certification schemes for electrical safety under the IECEE CB scheme. He is a chartered electrical engineer with more than 20 years experience of product compliance for electrical and mechanical equipment.

Stuart Brown, Environmental Managing Director, TRaC
Stuart Brown, Environmental Managing DirectorAppointed Managing Director in November 2007. Previously he was Test Facilities Manager for Flight Refuelling, part of the Cobham group, and spent his early career in the Environmental Engineering Department of British Aerospace at Stevenage.

Brendan Wall, CEng IMechE, Sales Director, TRaC
Brendan Wall, CEng IMechE, Sales Director, TRaCBrendan was appointed Sales Director in August 2009. He joined the group in 2005 as Business Development Manager for environmental test services. Before joining TRaC he spent five years in Application Engineering and Technical Sales roles for automotive test equipment. He studied Mechanical and Manufacturing Engineering at Trinity College Dublin.

John Charters, Radio Product Manager, TRaC
John has been involved in regulatory testing and certification for 16 years. During this time he has run TRaC North West EMC lab and he took over as Radio Product Manager in September 2008. He has worked on all types of transmitter receivers and transceivers ranging from 600kW broadcast transmitters to 1nW short range devices, from both a regulatory and developmental point of view.

About this Entry

This page contains a single entry by Alun Williams - Electronics Weekly.com published on May 26, 2010 8:48 AM.

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