Is Test Software considered a Monitoring and Measuring Device?

K
#1
Test Software?

Our products are Ion Beam Deposition and Etch tools, operating at extreme vacuum. As part of the final inspection "pump down" times and "leak back" rates are recorded and compared with specification. The data is accumulated by the tool's software, comparing the vacuum level over time. The software runs all the hardware and process parameters of the tool, this is just a very small utility available as part of the package.

My question is whether the software should be considered a monitoring and measuring device and controlled under Sec. 7.6.
 
Elsmar Forum Sponsor

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#2
I would consider it M&TE when considered as a whole. That is - the test device and the software are technically 1 package or 'box'. You calibrate or standardize it as a system, not as individual pieces.
 
Thread starter Similar threads Forum Replies Date
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 Checklist for RA and QA Review of DVT (design verification test) for Software Other US Medical Device Regulations 2
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
Marc Software QA (Quality Assurance) Test Site Software Quality Assurance 0
J How & how often to perform verification of Test Software of Automatic Test Equipment? General Measurement Device and Calibration Topics 3
F 4.11.1 Test Software Verification ? QS-9000 - American Automotive Manufacturers Standard 1
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 Test report to certify compliance with IEC 62304 IEC 62304 - Medical Device Software Life Cycle Processes 3
E Tensile test machine, tinius olsen 602 Manufacturing and Related Processes 1
M Test failure Root cause not found Customer Complaints 10
Moumen H Variations between ASTM A29 Standard for steel bars and Mill test certificates specs Manufacturing and Related Processes 1
D Tip test 10° -> 5° IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
M Sponsor name presented in the test report EU Medical Device Regulations 4
M Packing Validation & Accelerated Aging Test ISO 13485:2016 - Medical Device Quality Management Systems 2
S OEM full range calibrations vs Validation special test points Medical Device and FDA Regulations and Standards News 0
C IEC 60601 - 8.8.3 Dielectric Strength test. 4kv being applied to the ground conductor?! IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
S Shelf Life Test for IFU and Implant Card Other Medical Device Related Standards 1
S Mechanical Test Under FDA Freedom of Information Act Medical Device and FDA Regulations and Standards News 5
S Critical characteristic on manufacturing operations test procedure Inspection, Prints (Drawings), Testing, Sampling and Related Topics 0
R IEC 60601-1 Clause 15.3.2, Push test IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
S Knee Implant (Femoral -Cobalt chrome)-Sub chronic toxicity test (ISO 10993-11)choice of root Medical Device and FDA Regulations and Standards News 2
A Defining a lower ESD test level in IEC 60601 safety test IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
N Is there a need for clinical test of Class IIa products (for MDR)? EU Medical Device Regulations 2
A Is calibration of test weight required General Measurement Device and Calibration Topics 4
S Non parametric test for semi-quantitative data. Statistical Analysis Tools, Techniques and SPC 5
Ed Panek Disaster Recovery Test IT (Information Technology) Service Management 3
A How much does a complete biocompatibility test package cost? Other ISO and International Standards and European Regulations 1
M Is it normal / sufficient to have only the IEC 60601-1-2 test report without indicating IEC 60601-1? IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
Z Is Op Amp Common-Mode Rejection Ratio (CMRR) test applicable to battery operated devices? Other Medical Device Related Standards 0
E When to perform accelerated aging studies and transport test(OQ or PQ) Qualification and Validation (including 21 CFR Part 11) 4

Similar threads

Top Bottom