Software Test Report including IEC 62304 classification

#1
Hi Guys!

Our NB (SGS) recommended as per "shall":bonk: to include the IEC 62304 classification of the software running on/in our instruments into the release test reports. I have never heard about it that the Verification/Release Test Report shall contain a statement that the software is Class B (In our case the software is Class B according to IEC 62304). The IEC 62304 regulates the entire SW development cycle why the SW test report shall contain this information only?


I have googled here on elsmar but no found any related topic. Have anybody heard about this "issue"? :)

Thanks in advance,

Attila
 
Elsmar Forum Sponsor

yodon

Staff member
Super Moderator
#2
Re: Software Test Report including IEC 62304 classification?

Never heard of requiring it in the test report. Doesn't seem like any added value.

We generally have a Software Development Plan where we establish the software class. As you note, the software class drives the entire process so the Plan is structured around the class - including the V&V activities. We reference the Plan in our V&V documentation so that provides linkage back to the software class.
 

Marcelo

Inactive Registered Visitor
#3
Re: Software Test Report including IEC 62304 classification?

What "shall" he?s talking about? Is it about the clauses which define requirements for test record contents such as 5.7.5? If so, he?s misreading the standard, because, although there?s a "shall" and a [Class B, C] at the end, this [Class B, C] does not mean that it?s a part of the shall.

There?s no requirement to include the classification
in test reports.

As mentioned by Yodon, the Plan is the place where the classification is expected to be (although even this is not clear on the standard as a requirement).
 
#4
Re: Software Test Report including IEC 62304 classification?

Hello Attila. I don't think it's an issue either.
Ask your NB to clarify the requirement and its source.
There is a requirement to document the software safety classification in the risk management file. 4.3.c.
 
#5
Re: Software Test Report including IEC 62304 classification?

Thanks to All the comments and information!

I have made a simple Software levelclassification section into the Test report template. Hopefully this will meet the criteria on the next year audit :)

This comment from the Auditor was not a CAR, he highly recommended to include to the next audit :)

Thanks!
 
Thread starter Similar threads Forum Replies Date
S IEC 60601-1 Cl. 14 - Report changes in Software after Testing to Test Lab? IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
S SX MRP Software MTR (Material Test Report) Module Quality Assurance and Compliance Software Tools and Solutions 4
S Recommendations for a good commercially available Material Test Report (MTR) Software Document Control Systems, Procedures, Forms and Templates 2
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
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
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
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
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 13485:2016, Sections 4.1.6, 7.5.6 and 7.6 - Validation of Software - Need some Advice please ISO 13485:2016 - Medical Device Quality Management Systems 2
R Medical Device Software Certification IEC 62304 - Medical Device Software Life Cycle Processes 1
S HIPAA-compliant monitoring software (advice needed) Hospitals, Clinics & other Health Care Providers 0
A Software bug fixes after shipping a product EU Medical Device Regulations 3
J Medical software Patient outcome Medical Information Technology, Medical Software and Health Informatics 2
Y We are Looking for EASA LOA TYPE 1 experienced software developer Job Openings, Consulting and Employment Opportunities 0
F Grand Avenue Software, Q-Pulse or Qualio - which for a full eQMS? Medical Information Technology, Medical Software and Health Informatics 1
K SOUP (Software of Unknown Provenance) Anomaly Documentation IEC 62304 - Medical Device Software Life Cycle Processes 2
Q Storing and developing SAMD (Software as a Medical Device) in the Cloud IEC 62304 - Medical Device Software Life Cycle Processes 2
I Old Time Scatter diagrams for defect type and location- software Quality Tools, Improvement and Analysis 3
SocalSurfer AS9100 new certificate, but need QMS software, help Quality Assurance and Compliance Software Tools and Solutions 2
C Is my software an accessory? Telecommunication between HCP and patients EU Medical Device Regulations 10
K Verify Software Architecture - supporting interfaces between items IEC 62304 - Medical Device Software Life Cycle Processes 1
A What are the pros and cons of using an audit software for internal auditing? General Auditing Discussions 4
A Risk Number for each software requirement IEC 62304 - Medical Device Software Life Cycle Processes 7
R Shall a new UDI-DI be required when stand-alone software device's version is updated? EU Medical Device Regulations 1
S MDR GSPR Clause 17 - Software Requirements EU Medical Device Regulations 2
L Turkish Requirements - Does the Software need to be translated? CE Marking (Conformité Européene) / CB Scheme 2
MDD_QNA Medical Device Software - Is a Help Button required? IEC 62304 - Medical Device Software Life Cycle Processes 1
F Software as a Medical Device (SaMD) Technical File Requirements Manufacturing and Related Processes 1
D Software User Interface Languages for LVD and IVD CE Marking (Conformité Européene) / CB Scheme 2
A Software as Medical Device (SaMD) definition and its applicability Other Medical Device and Orthopedic Related Topics 4
K Software Validation for Measurement Tools used in Process Validation ISO 13485:2016 - Medical Device Quality Management Systems 2

Similar threads

Top Bottom