Software for Clinical Trials Management

A

andreiafilipaf

#1
In your opinion, a software product that is used to manage clinial trials, in a way that has contains the data collected during each trial, manages patient visits, is linked to the EMR that contains patient information, etc.. should be consider as a medical device or not?

Thanks for your feedback.
 
Elsmar Forum Sponsor

yodon

Staff member
Super Moderator
#2
Unless the software is used in the diagnosis, probably not. I presume that the software is not part of the device (or drugs) that are being trialed? The lines get pretty blurry these days but if it's clearly uncoupled from the device and is not used in diagnosis or treatment, then it's probably not a device.

Just completed working with a client who had similar software. Their client (trial sponsor) did not consider the software a device (and no mention has been made in that regard by anyone) but the sponsor DID require that the software be validated since it was collecting records that would be used in submission or to substantiate claims.
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#3
In your opinion, a software product that is used to manage clinial trials, in a way that has contains the data collected during each trial, manages patient visits, is linked to the EMR that contains patient information, etc.. should be consider as a medical device or not?

Thanks for your feedback.
In my opinion, it should not. The definition of medical device in the ISO 14155:2011 standard reads:
3.28 medical device:
any instrument, apparatus, implement, machine, appliance, implant, software, material, or other similar or related article

a) intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the specific purpose(s) of
1) diagnosis, prevention, monitoring, treatment or alleviation of disease,
2) diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury,
3) investigation, replacement, modification, or support of the anatomy or of a physiological process,
4) supporting or sustaining life,
5) control of conception,
6) disinfection of medical devices, and​

b) which does not achieve its primary intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its intended function by such means
 
Thread starter Similar threads Forum Replies Date
E Software Validation - Clinical Trials US Food and Drug Administration (FDA) 3
M Clinical Decision Support Software Question 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
M Informational US FDA Draft Guidance – Clinical Decision Support Software Medical Device and FDA Regulations and Standards News 0
S PMCF (Post Market Clinical Followup): Rationale for Exemption - Software Medical Devices EU Medical Device Regulations 6
L Traditional 510(K) - Software - Clinical testing? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
A Unreleased software for troubleshooting and clinical use ISO 13485:2016 - Medical Device Quality Management Systems 6
D FDA Approval for Diagnostic Software Clinical / Research US Food and Drug Administration (FDA) 4
Q Software as a medical device vs software not sold as medical device: local regulations for sale? EU Medical Device Regulations 4
Y Software updates considered servicing (7.5.4) ISO 13485:2016 - Medical Device Quality Management Systems 4
S How to perform verification of the Statistical Analysis Software? Qualification and Validation (including 21 CFR Part 11) 2
I Document Control Software Document Control Systems, Procedures, Forms and Templates 2
E Software maintenance Process Software maintenance Process to IEC 6204? IEC 62304 - Medical Device Software Life Cycle Processes 3
L Micro-Vu InSpec Software Program Qualification and Validation (including 21 CFR Part 11) 6
A For software change - New Channel of interoperability CE Marking (Conformité Européene) / CB Scheme 4
T IVDR Medical device software CE Marking (Conformité Européene) / CB Scheme 8
N ISO 13485 7.3.9 Change control in medical device software ISO 13485:2016 - Medical Device Quality Management Systems 6
C SharePoint Contract Management Software General Information Resources 0
gramps What do you think about automated QA testing For software app industry? Misc. Quality Assurance and Business Systems Related Topics 5
V Software as medical device (SaMD) replicated for multiple clients through APIs IEC 62304 - Medical Device Software Life Cycle Processes 5
U API Spec Q1 - 5.6.1.2 C (3) - Design software Oil and Gas Industry Standards and Regulations 3
B Complaint Records - Accessing records on Easy Track Software Records and Data - Quality, Legal and Other Evidence 3
GreatNate Master Control QMS software Quality Tools, Improvement and Analysis 0
GreatNate Anyone using the Intellect QMS software? Quality Assurance and Compliance Software Tools and Solutions 1
S DHF/DMR/MDF for a software-only, cloud-based, single-instance device Medical Information Technology, Medical Software and Health Informatics 2
H Software Validation for FFS Packaging Machine Qualification and Validation (including 21 CFR Part 11) 1
E Any sample of a full software life cycle IEC 62304 report ( any class )? IEC 62304 - Medical Device Software Life Cycle Processes 1
Q ISO 13485 7.5.6 Validation - Off the shelf Software ISO 13485:2016 - Medical Device Quality Management Systems 3
M ERP / QMS related software standards for Validation IEC 62304 - Medical Device Software Life Cycle Processes 6
J Do Software Subcontractors need to be ISO13485 compliant in the EU? EU Medical Device Regulations 3
D Safety data sheets software REACH and RoHS Conversations 2
N What are the software audit and control steps Reliability Analysis - Predictions, Testing and Standards 2
N Validating Software before getting approved as Class 2 device US Food and Drug Administration (FDA) 5
P Missing 1m visual alarm signal in case of software/display failure, mitigation? ISO 14971 - Medical Device Risk Management 3
B Software service provider as critical supplier ISO 13485:2016 - Medical Device Quality Management Systems 5
S Asterisk in DOE minitab software Using Minitab Software 23
M Surgical angle measurement guide device with an application software Medical Device and FDA Regulations and Standards News 1
M Advice needed for SEH Compliance Software and ISNETWord Compatabiliy Occupational Health & Safety Management Standards 2
bruceian Software Quality Metrics Software Quality Assurance 11
optomist1 How Secure Are Our Software Systems Software Quality Assurance 7
M 'Active' device? Software/laptop with attached camera 'looking' at passive metal probe EU Medical Device Regulations 3
D Software validation team Misc. Quality Assurance and Business Systems Related Topics 3
O Any info on release date of FDA “Computer Software Assurance for Manufacturing and Quality System Software” document? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
L Radiology software Class I exemption Medical Device and FDA Regulations and Standards News 3
O Software for comparing text of PDF files Contract Review Process 2
J Implementing an ISO 13485 QMS Software ISO 13485:2016 - Medical Device Quality Management Systems 6
K Software Updates in the Field and ISO scope ISO 13485:2016 - Medical Device Quality Management Systems 2
M Recurrent event analysis software (python) General Auditing Discussions 2
Y UL 1998 Standard: software classes Software Quality Assurance 0
P Need a programmer for QVI's VMS software for optical inspection machine Inspection, Prints (Drawings), Testing, Sampling and Related Topics 0
S IEC 62304 software costs and time Medical Device and FDA Regulations and Standards News 3

Similar threads

Top Bottom