4.11.1 Test Software Verification ?

F

Frank45

#1
Hello:

I would like clarification on the 3rd paragraph on page 43 of the QSR. Does test software refer to the OEM test software or comparative software included in a measuring system only? Or does this also apply to piece part programs used to verify specific features. For example: CMM programs, Tally round, Tallysurf piece part programs used to verify blue print features?
 
Elsmar Forum Sponsor

Marc

Hunkered Down for the Duration
Staff member
Admin
#2
I think the rule of thumb is if you're measuring something and software is involved it has to be validated in some way. That would include a CMM.

Sorry, I don't know what a Tally round is.
 
Thread starter Similar threads Forum Replies Date
S Checklist for RA and QA Review of DVT (design verification test) for Software Other US Medical Device Regulations 2
J How & how often to perform verification of Test Software of Automatic Test Equipment? General Measurement Device and Calibration Topics 3
R MSA for ATE (Automatic Test Equipment Embedded Software) Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 9
M Informational USFDA – Digital Health Update: The FDA Announces an Opportunity for Test Case Volunteers for the Test Plan for the Software Precertification Program Medical Device and FDA Regulations and Standards News 0
S Software Test Report including IEC 62304 classification IEC 62304 - Medical Device Software Life Cycle Processes 4
S IEC 60601-1 Cl. 14 - Report changes in Software after Testing to Test Lab? IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
D DPPM - Calculating the Defect Rate of a Software Test Statistical Analysis Tools, Techniques and SPC 9
S Can the Integrated Test be linked to Software Requirements? IEC 62304 - Medical Device Software Life Cycle Processes 13
S SX MRP Software MTR (Material Test Report) Module Quality Assurance and Compliance Software Tools and Solutions 4
T Embedded software requirements - Developer test tools within the same code Qualification and Validation (including 21 CFR Part 11) 3
Q Automated Test Software and System Validation 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
M Auditing Test Management Software such as HP Quality Center (HPQC) Test Tool Internal Auditing 1
S Recommendations for a good commercially available Material Test Report (MTR) Software Document Control Systems, Procedures, Forms and Templates 2
J Software Acceptance Test (Software Validation) Protocol template Software Quality Assurance 5
P Bartlett or Levene Test Software - Homogeneity of Variances Software Quality Assurance 8
C Control of the Development and Test Environment - Software for Medical Devices IEC 62304 - Medical Device Software Life Cycle Processes 2
B Software Beta Testing - Sample test plan or procedure wanted Other Medical Device and Orthopedic Related Topics 5
K Final Inspection for Software Product - Functional Test? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 3
T Software Integration Test Software Quality Assurance 3
U What is the purpose of a Software Test Plan? Software Quality Assurance 7
RoxaneB Employee/Professional Development and Test Software - Recommendations Requested Quality Assurance and Compliance Software Tools and Solutions 2
G Definition Test Software - Definition - ISO 9001:2000 Clause 7.6 Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 9
G Test Software 4.11 - We send the Collector out for Calibration but not the Software General Measurement Device and Calibration Topics 2
K Is Test Software considered a Monitoring and Measuring Device? General Measurement Device and Calibration Topics 1
Marc Software QA (Quality Assurance) Test Site Software Quality Assurance 0
T How to calibrate or validate a test software to conform with 4.11 General Measurement Device and Calibration Topics 3
M ISO 9001 - 4.11.1, Paragraph 3 - Test Equipment and Test Software General Measurement Device and Calibration Topics 1
E MSA for Push and Pull test Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 5
Z IEC 60601-2-25; Frequency response test Medical Device and FDA Regulations and Standards News 0
J Confusing on Harmonic Emissions/Voltage Fluctuations/Flicker test for CISPR 11 Class A Equipment IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
E Routine production tests - dielectric voltage withstand test IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
D Test Method Validation Qualification and Validation (including 21 CFR Part 11) 4
Crimpshrine13 Laboratory Scope - Calibration vs. Test Methods - IATF 16949 IATF 16949 - Automotive Quality Systems Standard 3
N IEC 60601-1-1 - Stress test, reference voltage IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
R Accelerated Aging - Creating test samples - Implantable medical device Question Other Medical Device Related Standards 4
E Mentor for Test Method Validation (TMV) Design and Development of Products and Processes 2
L ASQ's Biomedical Auditor Course Test ASQ - American Society for Quality 1
W Regarding Requirement for Hi pot & Leakage Current test Station Set-up IEC 60601 - Medical Electrical Equipment Safety Standards Series 6
R Regulatory Affairs Certification (RAC) prep - Practice test versus actual exam Professional Certifications and Degrees 0
R SAT (System Accuracy Test) temperature according to AMS2750E AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
D Test summary report example for design validation wanted - ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 1
S Documenting Design Verification Test Results (ISO 9001) Design and Development of Products and Processes 1
A Earth leakage current test for Permanently installed Large scale MEE IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
A Bench test report translation to English for 510(k) submission Other US Medical Device Regulations 2
J Production Line Test Brasil - High Voltage Dielectric Strenght Test Other Medical Device Regulations World-Wide 5
W Seeking Guidance Verification Test Strategy for Class B Medical Devices IEC 62304 - Medical Device Software Life Cycle Processes 1
J 510(k) for a control kit for an external IVD test kit 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
K Cord anchorage pull test IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
A IEC 60601-1 Dielectric Strength test for battery operated devices IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
M Minitab assistant: 1-Sample % Defective Test Using Minitab Software 1

Similar threads

Top Bottom