The Cove Business Standards Discussion Forums
ISO 14971 vs. IEC 62304 vs. 98/79/EC vs. ISO 13485 (Software Medical Device)
UL - Underwriters Laboratories - Health Sciences
ISO 14971 vs. IEC 62304 vs. 98/79/EC vs. ISO 13485 (Software Medical Device)
ISO 14971 vs. IEC 62304 vs. 98/79/EC vs. ISO 13485 (Software Medical Device)
ISO 14971 vs. IEC 62304 vs. 98/79/EC vs. ISO 13485 (Software Medical Device)
ISO 14971 vs. IEC 62304 vs. 98/79/EC vs. ISO 13485 (Software Medical Device)
ISO 14971 vs. IEC 62304 vs. 98/79/EC vs. ISO 13485 (Software Medical Device)
ISO 14971 vs. IEC 62304 vs. 98/79/EC vs. ISO 13485 (Software Medical Device)
ISO 14971 vs. IEC 62304 vs. 98/79/EC vs. ISO 13485 (Software Medical Device)
ISO 14971 vs. IEC 62304 vs. 98/79/EC vs. ISO 13485 (Software Medical Device)
ISO 14971 vs. IEC 62304 vs. 98/79/EC vs. ISO 13485 (Software Medical Device)
Go Back   The Elsmar Cove Business Systems and Standards Discussion Forums > > >
Forum Username

Elsmar Cove Forum Visitor Notice(s)

Wooden Line

ISO 14971 vs. IEC 62304 vs. 98/79/EC vs. ISO 13485 (Software Medical Device)


Monitor the Elsmar Forum
Sponsor Links




Courtesy Quick Links


Links Elsmar Cove visitors will find useful in the quest for knowledge and support:

Jennifer Kirley's
Conway Business Services


Howard's
International Quality Services


Marcelo Antunes'
SQR Consulting, and
Medical Devices Expert Forum


Bob Doering
Bob Doering's Blogs and,
Correct SPC - Precision Machining


Ajit Basrur
Claritas Consulting, LLC



International Standards Bodies - World Wide Standards Bodies

AIAG - Automotive Industry Action Group

ASQ - American Society for Quality

International Organization for Standardization - ISO Standards and Information

NIST's Engineering Statistics Handbook

IRCA - International Register of Certified Auditors

SAE - Society of Automotive Engineers

Quality Digest

IEST - Institute of Environmental Sciences and Technology


Some Related Topic Tags
differences (general), iec 62304 - medical device software life cycle processes, iso 13485 - medical device qms, iso 14971 - medical device risk management, ivdd, risk management and analysis, software medical devices
Reply
 
Thread Tools Search this Thread Rate Thread Content Display Modes
  Post Number #1  
Old 13th February 2017, 06:39 AM
HeatherC-S

 
 
Total Posts: 12
Question ISO 14971 vs. IEC 62304 vs. 98/79/EC vs. ISO 13485 (Software Medical Device)

Hi all

I'm in a bit of a pickle and need your help. We made software which is classed as an IVD and are currently undergoing registration for ISO 13485 (2016), we also work to IEC 62304. For risk management we are working to ISO 14971, however there are clashes with the IVDD and by default need to comply with the IVDD. I just want to clarify a few points.

1. Identified risks cover pretty much everything from design of the software, finished software, QMS processes involved with its design and development.

2. Although there is an assigned RPN score this is meaningless as from what I understand no risks can be accepted? Or can risks be accepted once there are suitable controls put in place?

3. All risks (regardless of score) must have a risk-benefit analysis applied to them. Is that correct?

Many thanks

Sponsored Links
  Post Number #2  
Old 13th February 2017, 07:45 AM
Marcelo Antunes's Avatar
Marcelo Antunes

 
 
Total Posts: 3,195
Re: ISO 14971 vs. IEC 62304 vs. 98/79/EC vs. ISO 13485 (Software Medical Device)

Hi

Quote:
1. Identified risks cover pretty much everything from design of the software, finished software, QMS processes involved with its design and development.
Sure.

Quote:
2. Although there is an assigned RPN score this is meaningless as from what I understand no risks can be accepted? Or can risks be accepted once there are suitable controls put in place?
What the deviation means is that you cannot simply accept risks because you identified the P x S as low. You have to justify it anyway.

RPNs have nothing to do with risk acceptability, they are only related to risk ranking. We are currently discussing this today at the JWG 1 meeting on the revision of ISO 14971 and will hopefully have some clear explanations in the future.

Quote:
3. All risks (regardless of score) must have a risk-benefit analysis applied to them. Is that correct?
That's what the deviation say, but it does not make much sense to do it for individual risks.
Thanks to Marcelo Antunes for your informative Post and/or Attachment!
Reply

Lower Navigation Bar
Go Back   The Elsmar Cove Business Systems and Standards Discussion Forums > > >

Bookmarks



Visitors Currently Viewing this Thread: 1 (0 Registered Visitors (Members) and 1 Unregistered Guest Visitors)
 
Thread Tools Search this Thread
Search this Thread:

Advanced Forum Search
Display Modes Rate Thread Content
Rate Thread Content:

Forum Posting Settings
You may not post new threads
You may not post replies
You may not post attachments
You may not edit your posts

BB code is On
Emoticons are On
[IMG] code is On
HTML code is Off


Similar Discussion Threads
Discussion Thread Title Thread Starter Forum Replies Last Post or Poll Vote
IEC 62304, ISO 14971 and FDA Medical Device SW Guidance mscottf 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5 18th August 2016 09:41 AM
ISO 14971 and IEC 62304 - Medical Device Software House KoD_RP ISO 14971 - Medical Device Risk Management 9 12th July 2016 07:47 PM
How to Align a Software Consulting/Contract Firm to ISO 13485+14971 & 62304 fottey ISO 13485:2016 - Medical Device Quality Management Systems 1 5th September 2014 07:17 PM
Requirements for Software to be CE Mark Compliant - IEC 62304 Medical Device Software aeropel IEC 62304 - Medical Device Software Life Cycle Processes 14 20th October 2013 11:55 AM
Software Design SOP to ISO 62304 (Software life cycle for Medical Device) ISO 13485 - Medical IEC 62304 - Medical Device Software Life Cycle Processes 3 15th August 2009 08:56 AM



The time now is 06:28 PM. All times are GMT -4.
Your time zone can be changed in your UserCP --> Options.



Misc. Internal Links


NOTE: This forum uses "Cookies"
The Elsmar Cove web site and all content is owned by Rabbithash Corp. as of 1 MAY 2018.
Unlike Facebook and other properties such as Linkedin, We don't buy, sell, or "share" visitor information. Never have, Never will...
GDPR Compliant since 1996, keeping Marc's vision alive!