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Atamo congratulates our client Lionstar Technologies on achieving crucial medical device quality certifications.

  

Lionstar reaches another milestone with ISO 13485 certification 

 Lionstar Technologies, a privately held medical technology company has received ISO 13485:2003 and EN ISO13485:2012 certification, an internationally recognised quality standard for medical devices. The ISO 13485:2003/ EN 2012 certification covers the design, development, production, sales and service of ECAL, Lionstar’s metabolic monitor for weight and energy management. The certificate demonstrates that Lionstar has successfully implemented a quality management system that conforms to the world-wide standard for medical device and diagnostic manufacturing.

“Achieving ISO 13485 certification was identified as strategic priority for Lionstar and a key milestone prior to the launch of ECAL in 2015”, explained John Wright CEO of Lionstar. “This certification demonstrates, (despite being a start up company) our commitment to the highest level of quality management and design controls to ensure delivery of safe and effective products,” Mr Wright added.  “ECAL will be used by health professionals worldwide and our international customer base can be assured that the products we deliver are of the highest standards, and that the ISO 13485:2003 criteria will provide a quality foundation upon which we and our partners will develop new diagnostic products,” he concluded.

The ISO (International Organization for Standardisation) is the world's largest developer and publisher of International Standards. Lionstar’s ISO 13485:2003 certificate was awarded by SGS UK through its subsidiary SGS Singapore.

 

More Approvals for ECAL

“We are also pleased to announce the CE approval for ECAL”, added Dr Sunny Tan, CSO of Lionstar. “The award is made under the Medical Device Directive, 93/42/EEC, and will allow us to fast track regulatory approvals in our key markets and meet our launch plans for early 2015”, Dr Tan added. For more Information please click here.  http://goo.gl/KDxK4M

“There is a clear need for devices like ECAL, particularly in long-term clinical weight management”, explained Lionstar’s European Marketing Director, Peter Robins. “ECAL will allow health practitioners to accurately measure energy production, fat use and energy efficiency, making it far easier to provide the correct nutrition advice for patients. Most leading health authorities including the WHO advocate the measurement of energy expenditure, but to date the technology is too expensive and often too inaccurate”. Mr Robins explained. “ECAL changes this”.

 

About Lionstar Technologies

Lionstar Technologies (LIONSTAR) is an integrated medical technology and health informatics company, with particular expertise in developing long-term metabolic health solutions, specifically for clinical weight loss.

 

LIONSTAR has developed a weight management system called METS (www.mymets.com.au), which comprises novel technology ECAL, proprietary know-how and evidence-led clinical services, for long-term weight management. For more information on Lionstar please click here.  http://goo.gl/UFAJxT

For more information please contact:

John Wright                 m.+61424605896        e. This email address is being protected from spambots. You need JavaScript enabled to view it.

Sunny Tan Chiok Ling m.+61439889000        e. This email address is being protected from spambots. You need JavaScript enabled to view it.This email address is being protected from spambots. You need JavaScript enabled to view it.

 

In Europe

Peter Robins                m.+447850020115      e. This email address is being protected from spambots. You need JavaScript enabled to view it.