Elsmar Cove Quality DiscussionsThe Cove Business Standards Discussion Forums More Free Files Forum Discussion Thread Post Attachments Listing Cove Discussion Forums Main Page
UL - Underwriters Laboratories - Health Sciences
Go Back   The Elsmar Cove Business Systems and Standards Discussion Forums > > >
Forum Username

Elsmar Cove Forum Visitor Notice(s)

Wooden Line

Software Validation – Clause 4.1.6 of ISO 13485:2016 - Page 2


Elsmar XML RSS Feed
Elsmar Cove Forum RSS Feed

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

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
iso 13485 - medical device qms, iso 13485:2016, mdd 93/42/eec, software validation
Reply
 
Thread Tools Search this Thread Rating: Thread Rating: 1 votes, 5.00 average. Display Modes
  Post Number #9  
Old 22nd August 2017, 06:47 AM
MC Eistee

 
 
Total Posts: 6
Re: Software Validation – Clause 4.1.6 of ISO 13485:2016

Since you wrote excel macros you must have had requirements for that.
So a good start would be writing them down.
Do not take excel into consideration. Just your requirements for that specific case. Using Excel is just a way to achive that.

When you wrote your requirements down you have your requirements / software specification.
Do a risk assessment on your requirements. You might link them for traceability purposes.
Your risk assessment indicates what kind of actions are necessary based on the overall risk of a specific requirement not fulfilling its purpose.
Then you should write test cases. What is your interaction with the excel tool to test a requirement. That is what should be document. When you are done with that you can actually start to test you excel tool. Do not forget to collect objective evidence. And there should be a final approval.

Do not forget to document and approve all your actions.

Hope that might help a bit getting started.
Thank You to MC Eistee for your informative Post and/or Attachment!

Sponsored Links
  Post Number #10  
Old 22nd August 2017, 08:44 AM
WilBryan

 
 
Total Posts: 35
Re: Software Validation – Clause 4.1.6 of ISO 13485:2016

That is a really well written approach. thanks for the great advice!
We have a lot of this information but formalizing it as an approach to meet the validation requirements is the link we were missing.

Sincere appreciation MC!
  Post Number #11  
Old 6th October 2017, 04:42 PM
Tatian

 
 
Total Posts: 11
Re: Software Validation – Clause 4.1.6 of ISO 13485:2016

Have anyone read ISO/TR 80002-2:2017 - Medical device software -- Part 2: Validation of software for medical device quality systems?
I'm wondering if it has a simpler path...
  Post Number #12  
Old 12th October 2017, 11:41 AM
MC Eistee

 
 
Total Posts: 6
Re: Software Validation – Clause 4.1.6 of ISO 13485:2016

The new ISO 80002-2 ist quite easy to read in my opinion. But still like most guidance documentation it follows the approach of defining your requirements, doing a risk assessment and based on that one doing some validation tests.

For small excel applications I would try to keep it as simple as possible like outline the post before. For validating your ERP System there is really a lot more to consider .

You could also get the AAMI TIR36 or GAMP 5 to get started.
Thanks to MC Eistee 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
ISO 13485:2016 Clause 7.4.2 regarding Supplier Quality Agreements tebusse ISO 13485:2016 - Medical Device Quality Management Systems 9 13th February 2018 11:34 AM
Struggling with ISO 13485:2016 Clause 6.2 - Level of Risk Associated with Work tebusse ISO 13485:2016 - Medical Device Quality Management Systems 3 27th October 2017 04:25 PM
ISO 13485:2016 Clause 4.2.5 - Control of Records - HIPAA Requirements GoSpeedRacer ISO 13485:2016 - Medical Device Quality Management Systems 10 16th October 2017 10:43 AM
ISO 13485:2016 Clause 6.2 - Effectiveness Check Rockdog ISO 13485:2016 - Medical Device Quality Management Systems 1 11th January 2017 01:06 PM
Interpreting clause 4.1.5 in ISO 13485:2016 SteveK ISO 13485:2016 - Medical Device Quality Management Systems 9 21st November 2016 05:57 PM



The time now is 03:40 PM. All times are GMT -4.
Your time zone can be changed in your UserCP --> Options.



Misc. Internal Links


NOTE: This forum uses "Cookies"