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Joe Hage
šŸ”„ Find me at MedicalDevicesGroup.net šŸ”„
September 2015
Are you ready for the ISO 13485 update?
4 min reading time

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 ā€œrisk-based approachā€ 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.

He’ll cover:
• How to prepare for the coming ISO 13485 changes & ensure compliance
• An overview of the current risk management standard for medical devices: ISO 14971
• Relevance of ISO 14971 and the impending ISO 13485 revision
• How to incorporate risk management throughout the design control process and why it matters
• An overview of key risk management terms & definitions
• How to use risk management as a tool during design & development, and not simply as a ā€œcheckboxā€ activity
• How to apply a ā€œrisk based approachā€ to all your organizations QMS processes

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:
• This is a great discussion! So many innovators of frugal devices are going through the same issues.

• 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,

Joe Hage
Medical Devices Group Leader

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].


Wen Wang
Software Developer
Thanks a lot.

Mina Adel
Medical Devices Professional
dear all iam seeking for a new challange i have good experience in medical devices pls check my profile or contact me at 00201282882935

Rajan Babaria
Dragon Drones • Escape This – Dallas • Green Leaf Hospitality
My company was recently certified for 13485. If you need a US-based electronics manufacturing partner, contact me.

Marrianne McGhee
CEO & Founder of ‘ScrubUp’​ – Surgical Software of the Future
I’ll be sharing this one. Thanks!

Joe Hage
šŸ”„ Find me at MedicalDevicesGroup.net šŸ”„
Pearlyn, there is only one time but we are recording the full session. I’ll send the replay, slides, and transcript to everyone who registers. Thanks for your question.

Shell Collins
Senior Biocompatibility Scientist at Abbott
Thanks for the post and link. Will definitely tune in.

Pearlyn Wang
Asia-Pacific Regional Lead – Flavors, Fragrances & Healthcare at BollorĆ© Logistics Asia-Pacific
Any other time slot?

Pearlyn Wang
Asia-Pacific Regional Lead – Flavors, Fragrances & Healthcare at BollorĆ© Logistics Asia-Pacific
I’m keen but in Asia so cannot attend the 1pm New York time.

David P. Depman āœ“
Sales and Team Leader at Xanda Body Marbling (Part of the MSB Group), Cofounder of MSB Group.
Looking forward to it. Thanks Joe.

Dink Liu
Market director at Zhengzhou SAFUTE Electronic Equips Co.,LTD
We want to undate our ISO13485.

Joe Hage
šŸ”„ Find me at MedicalDevicesGroup.net šŸ”„
Leong, the event is free of cost to Medical Devices Group members. Enjoy.

Andrew Anderson
Informatics and Scientific Software
I888

Mark Schnapf
Senior Project Engineer at Medtronic
Joe – Great advice on developing the app to not be the definition of a medical device.

Ee Bin Liew
Access-2-Healthcare’s Owner and Consultant
The ISO13485 has been approved to advance to the FDIS stage at an earlier date, but there were still some negative votes outstanding. ISO/TC 210/WG 1 met in Denver, Colorado, USA in June and Wokingham, UK in late August, to address comments received on the DIS2 version of the Standard and ensure that it is ready for balloting at the FDIS stage. At the Wokingham meeting the working group agreed to submit the FDIS for ballot, with the anticipation of approval and publication early in Q1 of 2016.

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 ā€˜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.

Cheers,
Ee Bin Liew

CEO -Shuky- Liat Nadel-Israeli Registration Holder Serv.
L.S Marketing & Registration – Israeli Indep. Reg.Affairs Reps. – Multdisc.Medical Devices Experts ( 8100+connect.)
Thanks for the info.

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