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ISO, the International Standards Organization, tells us risk-based changes to the ISO 13485 standard are “to be published by the end of 2015.”
The new 13485 will build upon principles laid out in ISO 14971, the current risk management standard for medical devices.
QA/RA consultant Jon Speer, founder of eQMS software platform greenlight.guru, is giving a free webinar about the update for the group: http://medgroup.biz/ISO-13485-webinar
Device developers and manufacturers, you’ll want to attend because the new ISO 13485 standard expects you to apply a “risk-based approach” to all of your organization’s QMS processes.
The old standard made you think about risk – but only during product realization.
It now specifically states you’ll be expected to apply risk management methods and techniques to every single QMS process, including outsourced processes as well.
Sounds exhausting! So special thanks to Jon for sharing his expertise with us.
A video replay, original slides, and transcript will be available to all who register – even if you can’t attend the live event.
Register at http://medgroup.biz/ISO-13485-webinar
Well, THAT really struck a chord!
I got quite an earful from last week’s post, “Launching without FDA Clearance,” at http://medgroup.biz/no-clearance.
One guy wrote privately just to yell at me and leave the group.
Another publicly wrote, “Somedays Joe Hage I just love you.”
Whatever it was, 171 comments later, it’s no surprise public comments overwhelmingly damned the idea.
But for the handful of readers who are in this situation, we now have quite a resource for you. One wrote, “I know a very similar situation that is very true… I am going to stop here because I could invite myself a notice from the firm’s lawyer!”
To me, the best answer came from Karen Boyd, simply: “Anyone can follow this Mobile Medical Applications link at http://ow.ly/SdFIj link and email questions to the FDA. To which another replied, “Asking FDA directly… while it seems like a simple and good idea, the information you will receive from the FDA may not be very helpful.”
Right or wrong, here are some others:
• A better approach might be to advise him to develop the app so that it doesn’t meet the definition of a medical device, and therefore does not need FDA clearance.
• … you say they use it at their own risk etc, I mean put enough disclaimers, the guy maybe fine. Now is it ethically and morally correct etc., is a different issue but you can cover the legal issues.
• It’s illegal, unethical and irresponsible to suggest. Regulations apply to medical device apps downloadable within the US regardless of where manufacturing occurs.
If you have the time, you’ll be very impressed with the members of our group! http://medgroup.biz/no-clearance
Love this week from Austria,
P.S. Thank you to my Czech hosts and if you’d like me to speak at your event anywhere in the world, email me at [email protected].
David P. Depman ✓
Ee Bin Liew
In addition, during the ISO Plenary meeting in November 2016, the members of the WG1 group will also meet to discuss on how help everyone utilize and comply with the Standard more effectively.
When the term ‘risk’ is used, the application of the term within the scope of the Standard pertains to safety or performance requirements of the medical device or meeting applicable regulatory requirements.
Risk management aspects within the Standard are already specifically included in the clauses.
References to ISO14971, other ISO standards, GHTF guidance etc, as appropriate have been largely kept to the source of certain definitions within the Standard and or underneath the clauses as a Note stated as for information, and as example.
hope that helps.
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