SBS - The Best Value in QMS software

Debug mode in software/device validation


Involved In Discussions
software is written in C, with a "macro" "#define HARDWARE_DEBUG 1". this macro is intended to be commented out for the release version. there is test code that is active when this macro is active, and it provides data via a serial connection that is not needed during normal operation.

from a regulatory point of view, are there issues with this approach to validating functional operation of the device? most of the functions are controlled by software.

thanks, any opinions or comments welcome.
Elsmar Forum Sponsor


Staff member
Super Moderator
I would presume there are some V&V tests that need to be done with hardware_debug enabled and that's ok as long as it's well documented. Where you can do testing without it, you should. V&V should be done as much as possible with the 'production' code. Isolate use of the debug version to as small a subset of tests as possible.


Trusted Information Resource
It is common to use "instrumented" code for testing below the system level. System level testing should be on the equivalent of product software.

As a matter of artistic preference, I would not rely on "commenting out" a line of code. I would prefer that a switch be used that is controlled by a specific header file, as it can be made much more obvious if the code is instrumented in this way.

Of course, the software could be architected and designed in such a way that the product code includes diagnostic routines that are invisible to the user.... but those also should be verified to work. *wink*
Thread starter Similar threads Forum Replies Date
Ninja Supply chains are in haywire mode? Buy, Sell or Trade - NO Commercial Advertisements 14
W Pfmea function requirement and failure mode FMEA and Control Plans 6
Z Is Op Amp Common-Mode Rejection Ratio (CMRR) test applicable to battery operated devices? Other Medical Device Related Standards 0
A Medical device Mode Of Action CE Marking (Conformité Européene) / CB Scheme 2
T Annual Validation as a detection mode on a PFMEA? FMEA and Control Plans 5
C Failure mode at 0h, vs. 1 year vs. 5 year... FMEA and Control Plans 8
Ahang "DIRECT MODE" or "ADJUSTED MODE" according to ISO 80601-2-56 Other Medical Device Related Standards 1
P Detection rating for a user (surgeon) related failure mode in DFMEA APQP and PPAP 3
Marc Skins - Experimental "Dark" Mode Elsmar Xenforo Forum Software Instructions and Help 9
B Is a Topical Antiseptic a Physical Mode of Action? EU Medical Device Regulations 2
T Question: Do we consider 60601-1-2 (4th ed) EMC testing a mode for a diagnostic port? IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
N PFMEA Potential Failure Mode for Weight FMEA and Control Plans 5
Z Failure Mode Identification in PFMEA according to AIAG FMEA Rev.4 FMEA and Control Plans 6
A Failure Mode from Operator "Components Fallen but Loaded" FMEA and Control Plans 3
V Preferred mode of facilitation - Teach vs Lecture Training - Internal, External, Online and Distance Learning 1
P UFMEA - Use Failure Mode Effects Analysis FMEA and Control Plans 7
S Seeking Feedback on ASQ Guide to Failure Mode and Effect Analysis FMEA and Control Plans 2
J Should failure mode caused by Fixture problem be into PFMEA? FMEA and Control Plans 2
T Would a Leak be a Failure Mode on a Design FMEA? Design and Development of Products and Processes 2
A Destructive Testing Failure Mode Sampling Plan Inspection, Prints (Drawings), Testing, Sampling and Related Topics 5
A FPA (Failure Prevention Analysis) and FMA (Failure Mode Avoidance) info wanted FMEA and Control Plans 6
L Cause vs. Mode in Process Control and Rankings FMEA and Control Plans 7
G Relation b/n Process Failure Mode RPN Value and the associated Process Failure Cost FMEA and Control Plans 3
P TIG Welding NG Mode Matrix for Robo Welding process IATF 16949 - Automotive Quality Systems Standard 1
P Problem with "failure mode? interpretation in PFMEA (Process FMEA) FMEA and Control Plans 8
bobdoering Honda's in crisis mode, cuts outlook World News 0
S Process Failure Mode Effects Analysis (PFMEA) Basics FMEA and Control Plans 4
S Basic PFMEA (Process Failure Mode Effects and Analysis) Questions FMEA and Control Plans 22
kedarg6500 Potential Failure Mode - Mix Charge for Hardness - Casting Process FMEA and Control Plans 1
N Definition Potential Failure Mode Definition and How to identify Failure Modes? Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 33
I Failure Mode help for Assembly Processes FMEA and Control Plans 8
M Difference between potential failure mode and potential effects of failure FMEA and Control Plans 11
W Plastic Part Painting/Spray Failure Mode - Sample PFMEA or control plan Manufacturing and Related Processes 7
W Potential Failure Mode - Machine Stroke not in specification FMEA and Control Plans 7
A Process FMEA - Help in deciding "detection ranking" of a failure mode FMEA and Control Plans 5
J DRBFM (Design Review Based on Failure Mode) - Toyota method Design and Development of Products and Processes 46
B How to demonstrate management commitment? Audit Failure Mode ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
A I have two doubts about PFMEA failure modes - How should I describe a "failure mode" FMEA and Control Plans 24
G Mechanical Failure as a Failure Mode in the PFMEA FMEA and Control Plans 28
Wes Bucey "Failure Mode Effect Analysis" 2nd Ed. by D.H. Stamatis Book, Video, Blog and Web Site Reviews and Recommendations 4
S Failure Mode SPC Statistical Analysis Tools, Techniques and SPC 10
Y Design (DFMEA) and Process (PFMEA) FMEA Failure Mode Identification Design and Development of Products and Processes 8
J Pre-Audit Panic Mode - ISO9001 General Auditing Discussions 10
H SFMEA - System Failure Mode Analysis FMEA and Control Plans 5
S Multiple controls for single failure mode FMEA and Control Plans 3
D Range - Concepts such as mean, median, mode and range Statistical Analysis Tools, Techniques and SPC 3
shimonv Working with a software developer who is not setup for IEC 62304 IEC 62304 - Medical Device Software Life Cycle Processes 9
Q Gage calibration / tracking software General Measurement Device and Calibration Topics 0
M Software verification and validation AS9100 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
Y RT-qPCR Software result EU Medical Device Regulations 0

Similar threads

Top Bottom