How to address unresolved Medical Device Software Anomalies?

R

Roland chung

Trusted Information Resource
#1
#1
Hi all,

We got feedback from FDA that the submission should include a list of all unresolved software anomalies for our devices (Moderate Level of Concern).

But we believe that all the bugs or defects have been solved before the product release.

Can you please share your experience on handling this problem?

Many thanks,
Roland
 
GAGEpack - Gage & Calibration Management
Elsmar Forum Sponsor
Y

yodon

Staff member
Super Moderator
#2
#2
I typically create a Version Description Document for each software release that describes the complete configuration, how it was built, etc. I have a section for "Known Anomalies / Open Issues" where I list anything related to the software from the issue tracking system. Along with the known issues, I describe why (risk based) it's ok for the software to be released with the anomalies.

If there are none, I state "There are no known issues with the software at the time of the release."

One fine point to consider: if your software contains SOUP / COTS, it would be good to also check with the supplier to see if there are any known issues. You would list those and also do a risk analysis to justify using the SOUP / COTS with the anomalies.

So far, that's been acceptable.

I can just envision a dilbert-esque auditor asking for a list of unknown anomalies. :)
 
M

MedTechSoftware

#3
#3
Hi Roland,

It is generally accepted that, even with only moderate levels of complexity in software systems, it is not possible to eliminate all bugs and issues. There are always residual issues, even if they have not been discovered.

If your software verification activities have been related to your software requirements specification, it may be that your requirements are a bit light and therefore test cases could be too superficial leading to a conclusion that you have eliminated all bugs.

I suspect that the FDA inspectors may be alluding to similar thoughts.

Hope this helps to point you in the right direction.
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
Ed Panek How to address a QMS Entry Error ISO 13485:2016 - Medical Device Quality Management Systems 8
P Update on NBOG 2014-3 to address MDR/IVDR, or any plan to do that? EU Medical Device Regulations 0
M Address change for a company with CE/ISO13485 EU Medical Device Regulations 2
J FDA notification of address change US Food and Drug Administration (FDA) 2
R Where does IATF 16949 address Process mapping? IATF 16949 - Automotive Quality Systems Standard 3
N Address of Legal Manufacturing Site in ISO 13485 certificates? ISO 13485:2016 - Medical Device Quality Management Systems 1
Ajit Basrur Physical Address on Product Labels (EU MDR perspective) EU Medical Device Regulations 2
A How to address Environmental & OHS Opportunities? ISO 14001:2015 Specific Discussions 6
Q Legal Manufacturing Address Change – multiple registrations at same address 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
K Changing the Address in 510(K) Approved Product 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
E Received a Major finding during IATF Surveillance audit for loss of BIQS Level 3 (more than 6 SPPS in 6 months)...how should we address SYSTEMIC CA? IATF 16949 - Automotive Quality Systems Standard 11
M Manufacturer address on the label Other US Medical Device Regulations 18
M GDPR - Is anonymizing sufficient to address right to erasure? Medical Information Technology, Medical Software and Health Informatics 3
K Implant Card - Full Manufacturer's Address - Space issues EU Medical Device Regulations 4
I Importer Address in addition to Manufacturer details on label EU Medical Device Regulations 13
S Medical Device Initial Importer (DII) Requirements - Delivery Address 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
B Manufacturing Company Address Change - implications for FDA Other US Medical Device Regulations 1
M Informational USFDA – Efforts to evaluate materials in medical devices to address potential safety questions Medical Device and FDA Regulations and Standards News 0
M Putting AR's name and address on label - Authorized Representative Labeling Requirements CE Marking (Conformité Européene) / CB Scheme 0
S Risk Approach doesn't address External Issues (Auditor's Comment) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 30
M Medical Device News FDA's Policies and Procedures Should Better Address Postmarket Cybersecurity Risk to Medical Devices Other US Medical Device Regulations 0
Marc Email Addresses - Changing your email address Elsmar Xenforo Forum Software Instructions and Help 0
B ISO 17025 8.5 Actions to address risks and opportunities ISO 17025 related Discussions 7
TheMightyWife Address Change - Medical Device Packaging Labelling Requirements EU Medical Device Regulations 7
M "Minor" Address Change Implications on Product Labeling Requirements Misc. Quality Assurance and Business Systems Related Topics 2
K Labeling - New company address Canada Medical Device Regulations 6
S How to address and implement OH&S opportunities in ISO 45001:2018? Occupational Health & Safety Management Standards 12
qualprod ISO 9001:2015 - Right method to address clause 6.1? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
Q ISO 14001:2015 Clause 6.1: Actions to address Risks & Opportunities ISO 14001:2015 Specific Discussions 2
J How to address IATF 16949 clause 5.1.1.1 in my Quality Manual IATF 16949 - Automotive Quality Systems Standard 6
Q ISO 9001:2015 - Clarification in 6.1.2 Note 1 (Options to Address Risks) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
P Requirements/guidance on what constitutes the Manufacturers "Address" EU Medical Device Regulations 7
M FDA Email Address needed for CECATS 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
R Actions To Address Risks and Opportunities IATF 16949 - Automotive Quality Systems Standard 1
V 21 CFR 820 Compliant way to use Kaizen to address Nonconformances Nonconformance and Corrective Action 9
R Is PFMEA (Process FMEA) for OEM sufficient to address Risk? ISO 13485:2016 - Medical Device Quality Management Systems 7
S Change of Medical Device Company Registered Address - Implications Quality Manager and Management Related Issues 3
B Different Label Address Required for EU? EU Medical Device Regulations 7
M How to communicate the change in company address to CFDA ? China Medical Device Regulations 1
C Appropriate ways to address Competency? Generic vs Specific ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
K Customer Address on ISO 17025 Test Report - Is email address okay? ISO 17025 related Discussions 9
R How to address an audit of another facility that is not ISO/TS 16949 ? IATF 16949 - Automotive Quality Systems Standard 9
S Cost of business lost / opportunity lost? How to address? Quality Tools, Improvement and Analysis 13
M ISO 9001:2008 Clause 7.6 - How to address in Software Industry ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
Marc Report: Facebook e-mail switch changed address books After Work and Weekend Discussion Topics 2
R Outsourcing of a Semi-Finished Product - Which major things to address in the QMS ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
B ISO 13485 & Change of Address/Location ISO 13485:2016 - Medical Device Quality Management Systems 8
P CMC Decision 3 - Manufacturers Address Content Requirements EU Medical Device Regulations 4
Q How would you address a Validation Gap/Escape (Product is in the Field) Qualification and Validation (including 21 CFR Part 11) 2
J Class IIa Medical Device - Can I over label to change an address? ISO 13485:2016 - Medical Device Quality Management Systems 3

Similar threads

Top Bottom