Software validation - off the shelf X-Ray

R

Revsar

#1
Hi Everyone,
we have an off-the-shelf X-Ray equipment, used to measure molded components.
the software has a model built for each component, and when the component is measured - the equipment compares the measured values to the model, to determine whether the measured components meet specs.
the equipment is validated and calibrated, but I wanted to check if a software validation is required for this kind of equipment (for medical devices)

thanks
 
Elsmar Forum Sponsor

yodon

Leader
Super Moderator
#2
If the software is involved in the processes you mention (comparing, making decisions, etc.) then yes. That would fall under 21 CFR 820.70:

(i) Automated processes. When computers or automated data processing systems are used as part of production or the quality system, the manufacturer shall validate computer software for its intended use according to an established protocol. All software changes shall be validated before approval and issuance. These validation activities and results shall be documented.
 
#4
Yes Don is spot on. You could also check with the equipment manufacturer if they have validated the software and that could help you in determining what level of software verification may be required for the intended use.
 
Thread starter Similar threads Forum Replies Date
Q ISO 13485 7.5.6 Validation - Off the shelf Software ISO 13485:2016 - Medical Device Quality Management Systems 3
C Software validation - Off The Shelf Software - Web hosted ISO 13485:2016 - Medical Device Quality Management Systems 6
Y OTS (Off The Shelf) Software Validation for 510k Traditional 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
T Validation of OTS (Off The Shelf) Software in Medical Devices IEC 62304 - Medical Device Software Life Cycle Processes 12
C Validation of OTS (Off-the-Shelf) Training Software - Necessary? Qualification and Validation (including 21 CFR Part 11) 13
I Validation of Commercial off-the-shelf software - Spreadsheets ISO 13485:2016 - Medical Device Quality Management Systems 16
M Software Validation SAP B1 for ERP ISO 13485:2016 - Medical Device Quality Management Systems 2
P Software validation for FPGA Software Quality Assurance 1
M 3D Scanner Software validation ISO 13485:2016 - Medical Device Quality Management Systems 7
D Software Validation Question ISO 13485:2016 - Medical Device Quality Management Systems 10
C. Tejeda Computer system validation approach for Minitab Statistical software Software Quality Assurance 9
John C. Abnet ...validation of computer software ISO 13485:2016 - Medical Device Quality Management Systems 14
B ERP software validation - risk assessment vs validation scope ISO 13485:2016 - Medical Device Quality Management Systems 11
R Validation of Software used in Verification Testing ISO 13485:2016 - Medical Device Quality Management Systems 2
Watchcat Software validation vs design V&V? Other US Medical Device Regulations 27
M Initial Importer/Distributor and Software Validation IEC 62304 - Medical Device Software Life Cycle Processes 1
E ISO 13485 software validation ISO 13485:2016 - Medical Device Quality Management Systems 7
Y ISO 13485:2015 Software Validation IQ/OQ/PQ ISO 13485:2016 - Medical Device Quality Management Systems 13
R Debug mode in software/device validation IEC 62304 - Medical Device Software Life Cycle Processes 2
M Software verification and validation AS9100 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
P Software verification and validation procedure IEC 62304 - Medical Device Software Life Cycle Processes 6
H Software Validation for FFS Packaging Machine Qualification and Validation (including 21 CFR Part 11) 1
M ERP / QMS related software standards for Validation IEC 62304 - Medical Device Software Life Cycle Processes 6
D Software validation team Misc. Quality Assurance and Business Systems Related Topics 3
silentmonkey Rationalising the level of effort and depth of software validation based on risk ISO 13485:2016 - Medical Device Quality Management Systems 10
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 3
K Software Validation for Measurement Tools used in Process Validation ISO 13485:2016 - Medical Device Quality Management Systems 2
S SOP for ISO 13485:2016 Quality related Software validation ISO 13485:2016 - Medical Device Quality Management Systems 16
K ERP System Software Validation - ISO13485 2016 4.1.6 Design and Development of Products and Processes 11
D Software validation in Medical Equipment Other Medical Device and Orthopedic Related Topics 20
C Looking for simple Software Validation IQ templates. Qualification and Validation (including 21 CFR Part 11) 4
R Validation of Medical Device Hardware containing Software - How many to Validate ISO 13485:2016 - Medical Device Quality Management Systems 1
F 21 CFR Part 11 - Implicit requirements - Validation plan for a Software as a Service Other US Medical Device Regulations 1
R ISO 13485 Software validation procedure and Quality Objectives Monitoring wanted Document Control Systems, Procedures, Forms and Templates 1
S Validation of COTS Equipment plus Software Qualification and Validation (including 21 CFR Part 11) 12
D Software Validation - Contract manufacturer of Components (PCBA's) Qualification and Validation (including 21 CFR Part 11) 7
Pmarszal Software Validation Training Course - Recommendations Training - Internal, External, Online and Distance Learning 3
T Software Validation Certificate (ISO 13485:2016) ISO 13485:2016 - Medical Device Quality Management Systems 19
R FDA Requirements - Printing Equipment Software Validation Qualification and Validation (including 21 CFR Part 11) 1
G Windows 10 OS build Software Validation US Food and Drug Administration (FDA) 1
S Where to keep Enterprise Resource Planning software (ERP) Validation Records ISO 13485:2016 - Medical Device Quality Management Systems 1
C Software validation (4.1.6 ISO 13485:2016) ISO 13485:2016 - Medical Device Quality Management Systems 20
M Software Validation Guidance Suggestions Various Other Specifications, Standards, and related Requirements 6
S QMS software validation - Documentation ISO 13485:2016 - Medical Device Quality Management Systems 5
A SOP for software validation of software in medical device IEC 62304 IEC 62304 - Medical Device Software Life Cycle Processes 5
R CNC Software Validation requirements as per ISO 13485:2016 Other ISO and International Standards and European Regulations 8
S What is the clause in ISO 13485 for SAP Software Validation? ISO 13485:2016 - Medical Device Quality Management Systems 3
P Software validation of Data Exporter ISO 13485:2016 - Medical Device Quality Management Systems 3
A Process Validation of QMS Software ISO 13485: 2016 Cl. 4.1.6 ISO 13485:2016 - Medical Device Quality Management Systems 26
P Software Validation for Equipment - Question ISO 13485:2016 - Medical Device Quality Management Systems 5

Similar threads

Top Bottom