The fastest and cheapest way to get hold of a (legal and therefore not free) copy of the ISO 14971:2019 standard on Risk Management is to purchase it from a web-store and download it as a pdf. But the prices may vary greatly depending on where you choose to buy the standard.
Below I have listed some different sources where you can buy the standard together with pricing information (correct as of June 2020). The prices are stated without subscriptions or memberships in the various web-stores:
|British Standards Institution||www.bsigroup.com||£165,50|
|Swedish Standards Institute||www.sis.se||SEK 1140|
|Estonian Centre for Standardization||www.evs.ee||€19,32|
Buying the standard from the British Standards Institution will cost you almost 10 times more than buying it at the Estonian Counterpart. And the content is the same, that is the whole idea with standardization!
Not only is the Estonian Centre for Standardization offering the ISO 14971:2019 standard (and many other standards) at a much lower price than their larger European and American competitors, but they also have an excellent service that allows you to access the full text of the standard for 24 hours for 2€. That is an excellent way of checking whether or not a standard applies to your product.
Would you like to learn more about Risk Management?
Get instant access to our online Risk Management for Medical Devices and ISO 14971:2019 course right here. In 6 hours, you can learn more about how to develop new medical devices and maintain them in organisations where design control requirements apply. This course is taken by quality assurance, project management, design engineering or those involved in R&D and product development teams.
Peter Sebelius (PMP) is a highly esteemed trainer, consultant and entrepreneur in the medical device industry. He is a member of the Joint Working Group that is revising the ISO 13485 and ISO 14971 standards.
He has vast ‘hands on’ experience too, having developed, amongst other things, a mechanical chest compression and an ex vivo perfusion machine for lungs. He has received numerous awards including the Great Design Award and the title “This year’s specialist” by Veckans affärer.