SBS - The Best Value in QMS software

Is the output of a device a Medical Device?

MakingADifference

Involved In Discussions
#1
Hi all.

We had an interesting discussion the other day and I was wondering what people's thoughts are regarding the output of a medical device.

We are developing a stand-alone piece of software that will produce a neurological report to guide patient management. This will be sold as a service to clinicians. The device will be used in-house only and will not be available to the clinician, they will just be sent a report.

Given the software is used in-house and not distributed, the question is whether this is actually a medical device? If we were not selling the report, would this still be a medical device? Although the clinician does not interact with the device, we are planning to sell as a service and the report would be used to guide patient management. For this reason, we are a medical device in my eyes.

I have never read about this kind of discussion before and the guidance (from what I have read) is not clear on this kind of argument. What do others think?
 
Elsmar Forum Sponsor

Tidge

Trusted Information Resource
#2
I don't think this rises to the level of medical device, until you market it as such. Don't take this the wrong way, but I don't see much theoretical difference between consulting this expert and consulting a crystal ball. If someone was selling crystal balls for this purpose, they would have to treat them as medical devices, but otherwise the medical device regulations aren't the ones of interest.

There is a completely different question: "Is this an accepted medical practice." Folks consult all sorts of people for medical assessments; this is a different area of (potential) regulation.
 

mihzago

Trusted Information Resource
#4
If the information you provide in the report meets the definition of a medical device, then yes, it makes it a medical device. The platform and what a patient or a clinician interacts with is irrelevant.
Depending on the information you provide, this may fall under a clinical decision support (in the US at least), which may or may not be exempted/excluded.
How is your software getting information about the patient?
 

Watchcat

Trusted Information Resource
#6
What kind of input serves as the basis for the report? Data from the literature? Data from an individual patient?
 
Thread starter Similar threads Forum Replies Date
shimonv Classification of a cloud- base viewer for the output from a medical device US Food and Drug Administration (FDA) 7
J Medical Device Electronics - Secondary to output isolation for 1 MOPP IEC 60601 - Medical Electrical Equipment Safety Standards Series 9
R Should Medical Device SIGNAL INPUT/OUTPUT PART be overloaded? IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
G Device Output (Reports) - Any regulatory requirements? US Food and Drug Administration (FDA) 4
L Class II (Double Insulated) Power Supply with Output Tied to Earth: FE or PE? IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
P Arena simulation, How can my Arena model have exactly the same output each time I run it? Process Maps, Process Mapping and Turtle Diagrams 0
N Example for design and development planning,input,output,review,verification,validation and transfer Misc. Quality Assurance and Business Systems Related Topics 4
C Output Matters! Internal Auditing 4
C Essential Design Output(s) and Design transfer 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 11
S What's meant by ISO9001 clause 8.7 non conforming output? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
shimonv Design input/output traceability for mechanical parts ISO 13485:2016 - Medical Device Quality Management Systems 31
D Should "Waste" be included as Output in SIPOC Chart? Process Maps, Process Mapping and Turtle Diagrams 8
K Nonconforming Output vs. Nonconformity vs. Nonconforming Product Nonconformance and Corrective Action 2
B Zeiss CMM Calypso output to Excel or CSV file Help Inspection, Prints (Drawings), Testing, Sampling and Related Topics 17
T Control of Nonconforming Product Output (Components Parts) IATF 16949 - Automotive Quality Systems Standard 3
S IEC 60601-2-27: What does "linear within ±20% of the full scale output" mean? IEC 60601 - Medical Electrical Equipment Safety Standards Series 6
K What does MIC, CMI and CLSQ stand for in the measurement software output? Calibration and Metrology Software and Hardware 2
R [Minitab] DOE Output vs. Actual Data Using Minitab Software 6
S OHSAS 18001 Typical Input and Output Examples Occupational Health & Safety Management Standards 4
O Camio Output Control - Programming on Camio 4.6 CMM Software Inspection, Prints (Drawings), Testing, Sampling and Related Topics 1
S Minitab 13 Cumulative Distibution Plot and Output Using Minitab Software 3
somashekar What is D&D Output for appropriate information for Production? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
A Essential Design Output - Still a problem 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 7
R Spacing between the solder eyes of the fuse input/output leads IEC 60601 - Medical Electrical Equipment Safety Standards Series 17
M Management Review - AS9100 Clause 5.6.3 Review Output AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 12
K Unclean Gages affect Measurement Output General Measurement Device and Calibration Topics 5
S Tutorial wanted for interpretation of Minitab GLM Output Using Minitab Software 6
A ISO/TS 16949 - 7.3.3.2 Manufacturing Process Design Output IATF 16949 - Automotive Quality Systems Standard 6
F AS9100 Management Review NCR help - Output of the MR is not Adequate AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
A Management Review Meeting (MRM) Input & Output Interpretation Management Review Meetings and related Processes 7
P I-MR Chart Interpretation - Minitab Chart Output Statistical Analysis Tools, Techniques and SPC 5
S Definition Output and Outcome - Differences and Definitions Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 13
A ?820.30(d) Design Output Release - Before or After Verification? Design and Development of Products and Processes 6
A Best Way for SPC via Optical Comparator with output to Computer for Data Analysis Statistical Analysis Tools, Techniques and SPC 4
T Input/Output/Specifications - Records vs. Forms 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 9
S Calibrating Thermometer with Simulated Output Temperature from Fluke 5520A General Measurement Device and Calibration Topics 6
S TS 16949 7.3.3.2 Question - Manufacturing Process Design Output. IATF 16949 - Automotive Quality Systems Standard 8
A Identification of "Essential Design Output" 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 17
D Design Input/Output and Design V&V (Verification and Validation) Interpretations 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 14
R How to understand the "full scale peak-to-valley output" mentioned in IEC 60601-2-27 IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
M Design Input & Output in Stages - Overkill? ISO 13485:2016 - Medical Device Quality Management Systems 16
J Use of Consultants - Design Output Approval 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
M Management Review Input and Output Content Requirements Quality Management System (QMS) Manuals 2
sagai Are some Design Input elements part of the Design Output? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
D Confusion in writing a SIPOC (Supplier, Input, Process, Output, Customer) Six Sigma 5
L Arima Output - Relationship between my raw data and the residuals generated Using Minitab Software 1
P Inner Diameter Surface Finish Ra Value vs. Surface Finish Graph Output Manufacturing and Related Processes 11
R Design Input/Output Form - Your feedback appreciated ISO 13485:2016 - Medical Device Quality Management Systems 3
S Do you consider 'unintended' process output(s) while mapping a process? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
K What is 'output of risk management' in ISO 13485, Cl 7.3.2(e).? ISO 13485:2016 - Medical Device Quality Management Systems 7

Similar threads

Top Bottom