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Hello, I am working in local medical device importing company. I’d like to listen to your experience and opinion about Application of ISO14971 to the Sales site independently. We are not a manufacturer and there are no local regulation or obligation that sales site shall apply ISO14971 to my knowledge. But, I heard from someone that we should do. Is there anyone that in similar situation? If sales site should adopt ISO14971, anyone can advise how to? ISO14971 is very much focused on product related risk for its lifecycle and I don’t have idea how to apply the standard for commercial process independently. Any advice or idea sharing will be appreciated! source: https://www.linkedin.com/groups/2070960/2070960-6341279711259295746 Marked as spam
 Posted by Asked on November 28, 2017 12:00 am
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If you are not the Design Authority (ie not the one who developed the device) and instead you are just a distributor or reseller, then 14971 doesn't apply to your organisation to my understanding. Risk for Medical Devices is very much from the design point of view so there's no reason why a distributor/sales company would need to comply to 14971, and in all honesty I have no idea how you'd be able to do it even if you wanted to!
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Ronald Boumans
Dear Hyemi, You are correct, ISO 14971 focuses on the device during its life cycle. For an importer this is not practical. The ISO 13485 standard on quality management systems for medical devices may be more relevant. It will help you to play your role in the Post-Market Surveillance activities of the manufacturers you are working with.
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Ivan Liljegren
Maybe they are mixing up business/process risk management and product risk management? The ISO 13485:2016 as well as ISO 9001:2015 require a risk based approach throughout the quality management system. ISO 31000 is the reference standard for this kind of risk management.
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Hyemi Shin (신혜미,차장)
Dear all! Thanks for those good advice. I totally agree with your opinion. I also thought it mixed up biz/process RM but I realized that our NB requested for us to do risk management with what we can do because we apply ISO13485. Hmm.. anyways we need to do it.. thanks again for your expertise.
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