Intertek Becomes First Certification Body Approved to Issue ISO 13485 Certificates Under Health Canada/TGA MOU
New service allows Canadian medical device manufacturers to meet both Canadian and Australian quality system requirements through a single audit.
Montreal, Canada, October 27, 2010 --(PR.com)-- Intertek, a leading global provider of quality and safety solutions, announced today that it has become the first certification body to be recognized under a memorandum of understanding (MOU) between Health Canada and the Therapeutic Goods Administration (TGA) of Australia.
Under the MOU, the TGA will accept ISO 13485 certificates issued by select Health Canada-recognized (CMDCAS) registrars, such as Intertek, to eligible Canadian medical device manufacturers exporting to Australia. By having a local auditor perform a single quality management system (QMS) audit that covers Canadian, Australian, and other regulatory requirements, manufacturers can reduce operational disruptions, lower their audit costs, and save valuable time.
"The Australian medical device market is a $2 billion industry where over 85% of the devices are imported. The new MOU will help Canadian manufacturers expand their sales and reach the Australian market," said Christine Forcier, Intertek’s North American program manager for medical management systems certification.
Intelerad, a Montreal-based provider of Picture Archiving and Communications Systems (PACS) and workflow solutions for medical imaging, hosted the witness audit that helped lead to Intertek’s approval. Intelerad delivers its entire suite of radiology environment applications to the Australian market, including their flagship applications, IntelePACS and InteleViewer.
When preparing for their MOU audit, Intelerad found that there was no need to overhaul their QMS, which was already in compliance with ISO 13485:2003, the Medical Device Directive (MDD) and the U.S. FDA’s Quality System Regulations. Their system only required minor modifications to address those areas where Australia has specific regulatory requirements, such as clinical evaluation, labeling and post-market surveillance.
"We felt that the witness audit would be a great opportunity for us to learn more about the Australian quality management system and regulatory requirements, while strengthening our relationship with the Intertek team," said Anibal Jodorcovsky, Intelerad’s executive vice president of quality systems and Chief Customer Officer. "We like Intertek's auditors and their general approach to the regulations. Overall, it was an excellent experience."
Intertek presented a webinar to inform Canadian medical device manufacturers about the quality system requirements of the MOU during the confidence-building phase of the MOU. A recording of this webinar is available for instant replay at: http://www.intertek.com/auditing/medical/iso-13485/australian-compliance-webinar/
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About Intertek
Intertek is a leading provider of quality and safety solutions serving a wide range of industries around the world. From auditing and inspection, to testing, quality assurance and certification, Intertek people add value to customers' products and processes, supporting their success in the global marketplace. Intertek has the expertise, resources and global reach to support customers through its network of more than 1,000 laboratories and offices and over 26,000 people in more than 100 countries. For more information, visit www.intertek.com.
About Intelerad
Intelerad Medical Systems is a recognized leader in medical imaging PACS and workflow solutions. IntelePACS relies on a scalable, flexible, and fault-tolerant architecture. Intelerad solutions like InteleOne have a strong reputation for reliability, flexibility, and performance in complex, multi-site environments with challenging workflows. www.intelerad.com
Under the MOU, the TGA will accept ISO 13485 certificates issued by select Health Canada-recognized (CMDCAS) registrars, such as Intertek, to eligible Canadian medical device manufacturers exporting to Australia. By having a local auditor perform a single quality management system (QMS) audit that covers Canadian, Australian, and other regulatory requirements, manufacturers can reduce operational disruptions, lower their audit costs, and save valuable time.
"The Australian medical device market is a $2 billion industry where over 85% of the devices are imported. The new MOU will help Canadian manufacturers expand their sales and reach the Australian market," said Christine Forcier, Intertek’s North American program manager for medical management systems certification.
Intelerad, a Montreal-based provider of Picture Archiving and Communications Systems (PACS) and workflow solutions for medical imaging, hosted the witness audit that helped lead to Intertek’s approval. Intelerad delivers its entire suite of radiology environment applications to the Australian market, including their flagship applications, IntelePACS and InteleViewer.
When preparing for their MOU audit, Intelerad found that there was no need to overhaul their QMS, which was already in compliance with ISO 13485:2003, the Medical Device Directive (MDD) and the U.S. FDA’s Quality System Regulations. Their system only required minor modifications to address those areas where Australia has specific regulatory requirements, such as clinical evaluation, labeling and post-market surveillance.
"We felt that the witness audit would be a great opportunity for us to learn more about the Australian quality management system and regulatory requirements, while strengthening our relationship with the Intertek team," said Anibal Jodorcovsky, Intelerad’s executive vice president of quality systems and Chief Customer Officer. "We like Intertek's auditors and their general approach to the regulations. Overall, it was an excellent experience."
Intertek presented a webinar to inform Canadian medical device manufacturers about the quality system requirements of the MOU during the confidence-building phase of the MOU. A recording of this webinar is available for instant replay at: http://www.intertek.com/auditing/medical/iso-13485/australian-compliance-webinar/
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About Intertek
Intertek is a leading provider of quality and safety solutions serving a wide range of industries around the world. From auditing and inspection, to testing, quality assurance and certification, Intertek people add value to customers' products and processes, supporting their success in the global marketplace. Intertek has the expertise, resources and global reach to support customers through its network of more than 1,000 laboratories and offices and over 26,000 people in more than 100 countries. For more information, visit www.intertek.com.
About Intelerad
Intelerad Medical Systems is a recognized leader in medical imaging PACS and workflow solutions. IntelePACS relies on a scalable, flexible, and fault-tolerant architecture. Intelerad solutions like InteleOne have a strong reputation for reliability, flexibility, and performance in complex, multi-site environments with challenging workflows. www.intelerad.com
Contact
Intertek
Stacey Corbin - Global Marketing Manager, Systems Certification
+1 978 929 2116
www.intertek.com
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Intelerad Medical Systems
Helene Gey - Vice-President of Marketing
+1 514 931 6222
helene.gey@intelerad.com
www.intelerad.com
Stacey Corbin - Global Marketing Manager, Systems Certification
+1 978 929 2116
www.intertek.com
--------------------------------
Intelerad Medical Systems
Helene Gey - Vice-President of Marketing
+1 514 931 6222
helene.gey@intelerad.com
www.intelerad.com
Contact
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