Beta Testing FDA Regulated Medical Device Software vs. Nonconforming product?

A

ariannas

#1
I've been tasked to develop a process for beta testing FDA regulated medical device software as part of design validation. The software is Class I.

Scenario: the software would be installed at a healthcare facility in a pre-agreed upon, limited, controlled way, and would NOT to be used for patient care. The goal would be to evaluate the behavior/performance of the software in scenarios where we can't realistically simulate all the subtleties of an actual facility's IT system.

I'm trying to work out if the above would mean that the software would be treated as nonconforming product or not (21 CFR 820.90).

I feel like I'm asking a "duh" question but I am having trouble putting together the pieces on my own. Any feedback would be much appreciated.
 
Elsmar Forum Sponsor

yodon

Staff member
Super Moderator
#2
I don't see the utility in treating the software as NC. Not even sure what you would do.

As part of the validation protocol, you should define the environment where it's installed and how the installation would differ from the production environment (and why that wouldn't invalidate the results gained from the test environment).

At most, you might want to have a build number / identifier that indicates it's a beta release (e.g., About --> SW Version). That's pretty typical.
 

Aphel

Involved In Discussions
#3
Hello ariannas,

I think your case does not count as a non conforming product acc. 820.90.
NC product means it is not conform regarding a specifiaction out of your device master record...

Normally a beta version of a software conforms to a defined number of requirements out of your software requirements specification before you start beta testing...
And after your beta test you have a lot of feedback regarding the performance of the software and of course some information about bugs...
Next you loop back in your development process and finalise your software...respectively you start your software maintenance procedure (acc. to EN 62304). And as you mentioned...all these actions happen before the product is officially launched...

Best regards,
Aphel
 
R

ryno fan

#4
Does FDA permit beta testing of Class I regulated medical device software on actual patients?
 
Thread starter Similar threads Forum Replies Date
shimonv 'Beta testing' & Design Controls 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6
B Software Beta Testing - Sample test plan or procedure wanted Other Medical Device and Orthopedic Related Topics 5
M Quality and Customer Satisfaction - Is beta testing required? Misc. Quality Assurance and Business Systems Related Topics 11
chris1price Sterilization using beta radiation Other Medical Device Related Standards 2
S Need help wrapping my head around confidence vs beta error Statistical Analysis Tools, Techniques and SPC 2
K What is the Beta RISK for S chart OF XBAR-S chart Statistical Analysis Tools, Techniques and SPC 0
shimonv Classification of Complaints from Beta Sites - Complaints Definition per QSR 820.3 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
I Alpha and Beta in the Sampling Plan for ISO 2859 & ISO 3951 Inspection, Prints (Drawings), Testing, Sampling and Related Topics 13
M Does anyone have an electronic Gamma and Beta Table Statistical Analysis Tools, Techniques and SPC 4
kisxena Beta Trial While 510(k) is Being Reviewed 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
Stijloor Mozilla Firefox 3 Beta 5 keeps crashing After Work and Weekend Discussion Topics 5
D LTPD, Alpha and Beta for this plan. Inspection, Prints (Drawings), Testing, Sampling and Related Topics 12
D Beta > 1 for new design? Durability test for a new system and no previous test data Reliability Analysis - Predictions, Testing and Standards 1
B Weibull Model - Reliability Analysis - Alpha, Beta & gamma value formulas Reliability Analysis - Predictions, Testing and Standards 3
A Inference for Regression Slope in Minitab - Significance test for Beta Using Minitab Software 0
D TUR's to alpha / beta risk factors Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 12
Marc CrossOver public beta: Allows Windows apps to run without Windows on Intel-based Macs After Work and Weekend Discussion Topics 0
Claes Gefvenberg Vista beta 2 available. If you dare... After Work and Weekend Discussion Topics 4
S Whether the word BETA means prototype samples or the Production samples IATF 16949 - Automotive Quality Systems Standard 1
Wes Bucey IE 7 Beta - your experience? After Work and Weekend Discussion Topics 8
Marc Internet Explorer 7 Beta 2 Preview - Bug reports are flooding in After Work and Weekend Discussion Topics 3
D What is beta software? Software Quality Assurance 1
Marc Errors - Uncertainty Type I, II, or Alpha, Beta vs. Gage R&R Measurement Uncertainty (MU) 1
E 60601-1 - Tilt testing - Tensile safety factor IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
V Setup for testing against ISO14708 clause 16 (protection of the patient from herms caused by heat) Other Medical Device Related Standards 0
gramps What do you think about automated QA testing For software app industry? Misc. Quality Assurance and Business Systems Related Topics 5
B In house NIOSH pre Testing accepted by NIOSH? US Food and Drug Administration (FDA) 1
M Bacteriostasis/Fungistasis Testing Other Medical Device and Orthopedic Related Topics 6
P Sample Size for Distribution Simulation Testing Inspection, Prints (Drawings), Testing, Sampling and Related Topics 11
N EN 813, EN 12277, EN 1497 - Testing some harness prototypes to an EN standard Various Other Specifications, Standards, and related Requirements 0
S What should i choose for "testing procedure" characteristics? (N95) General Information Resources 0
D Essential performance and EMC immunity testing IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
J Biocompatbility testing on Class 1 device requirements Other US Medical Device Regulations 12
Q Summative Usability Evaluation Testing: prior or during Clinical Investigation? Human Factors and Ergonomics in Engineering 6
B NIOSH Approval for Surgical N95 Respirators - Required testing US Food and Drug Administration (FDA) 2
M ECG lead leakage currents - How to specify ECG leads during electrical safety testing IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
C Stress / Challenge Conditions for Design Verification Testing to Reduce Sample Size 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 11
D CFR Title 14: Aeronautics and Space PART 120—DRUG AND ALCOHOL TESTING PROGRAM Federal Aviation Administration (FAA) Standards and Requirements 3
lanley liao Purchase Acceptance Criteria - Tensile testing Oil and Gas Industry Standards and Regulations 2
M Device mounted at IV pole - what about mechanical stability testing? IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
A Outsourcing IEC 60601-1 Ed 3.2 Testing IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
J Cochlear Implant Testing 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
A Class I (exempt) testing requirements Other Medical Device Related Standards 0
JoCam Electrical Testing for Japan, PSE or CB Scheme Other Medical Device Regulations World-Wide 0
M Who are the go to companies for non-destructive hardness testing? General Measurement Device and Calibration Topics 3
M Determining if an Insulin Pen Testing Machine is a Medical Device? EU Medical Device Regulations 4
P Testing cloud-based backups IT (Information Technology) Service Management 7
I IATF Lab Scope Testing Qualification and Competency Documentation IATF 16949 - Automotive Quality Systems Standard 3
N Chemical Testing on Medical Devices - Solutions in a container closure system (bag) EU Medical Device Regulations 1
M Comparing data from destructive testing Inspection, Prints (Drawings), Testing, Sampling and Related Topics 7

Similar threads

Top Bottom