Essential Requirements Checklist for Standalone Software

DH1981

Starting to get Involved
#1
For standalone software that is being run on a piece of hardware I was under the impression the hardware does not need to be considered with regard to the essential requirements checklist?

I was under the impression the hardware will be CE marked in its own right and if I were to incorporate it in to the ER checklist, how would I be able to reference any documentation as surely only the original manufacturer has access to this?
 
Elsmar Forum Sponsor

mihzago

Trusted Information Resource
#2
You should not need to include or reference technical documentation of the hardware in your SAMD tech doc; however, you should have documentation that demonstrates your software meets all essential requirements when used with that hardware as a system.
In other words, you would probably need to acquire the target hardware device and test/evaluate your software with it to make sure it works as intended. The results of this evaluation would be documented and included in your tech doc.
 

yodon

Staff member
Super Moderator
#3
The software does have to run on something and so you want to scope what you support. For example, something designed to run on a Windows platform. Do you support running on Windows 7, 8,10? (Dare I ask about Vista... they're still out there!) Can it be 32 bit or 64 bit? (Mobile applications the same way: all the Apple and Samsung products / OSs). Agree with @mihzago that you want to test on whatever you support and ensure those configurations are explicitly stated in your user documentation. (Even better if you can restrict the application from running on unsupported hardware!).

Same goes for infrastructure software; e.g., browsers, database engines, etc. Unless you package everything necessary to run or don't rely on any such software, there's even more testing warranted (the combinations can get quite endless so you do have to bound it).
 

dgrainger

Trusted Information Resource
#4
You need to consider the whole combination of software and hardware for all Essential requirements as per ER 9.1.
For example, you can't ignore infection issues if you are running an app on a tablet computer.
 

DH1981

Starting to get Involved
#5
I'm still totally confused so how can standalone software actually ever exist? Essentially you CE mark as a whole system then not the individual piece of software without any hardware
 

yodon

Staff member
Super Moderator
#6
I'll respectfully disagree with @dsgrainger and the assertion that the hardware the software runs on must be considered part of the device (unless you actually supply the tablet as part of the system). That would open up a huge can of worms.

Granted, there are some fuzzy areas like environment and display characteristics. Again, I go back to what I said earlier regarding the platforms you claim to support.
 

dgrainger

Trusted Information Resource
#7
It's almost impossible to show you meet the ERs if you don't look at the whole combination!
If you don't you are clearly not in compliance with the directives.
 

DH1981

Starting to get Involved
#8
Thanks for the responses.
So to appease the competent authority (whom are insisting the ERC considers the whole system even though the product is not incorporated into the hardware when it placed on the market) what documentation would you suggest I reference under ER 9.1 to demonstrate the hardware (tablet) is considered in this instance?
 

yodon

Staff member
Super Moderator
#9
The hardware platform the software runs on is NOT a medical device! Assuming you are making the software available and not supplying it pre-loaded on a hardware platform, you have no control over what it's installed on. At best, you can assert what the intended environment is, what the supported platforms are (what you've done V&V on), and such.

You have to be cognizant of the intended platforms: software designed to run on smart phones will be different from those designed to run on tablets which will be different from running on a desktop. But you have no (or at best limited) control over the actual device on which it's installed! You can't list every combination of phone / version / patch / OS / version / patch in your essential requirements! As I noted earlier, at best, you can say what the intended use environment is and provide sufficient evidence that it meets specification for those.

You should certainly consider the risks if running outside your intended platforms and take measures to prevent that if the risks are substantial.

Please take a look at this document from the IMDRF: http://www.imdrf.org/docs/imdrf/final/technical/imdrf-tech-151002-samd-qms.pdf
 

dgrainger

Trusted Information Resource
#10
You will have access to the IFUs of the hardware you plan to run the software on. This will contain details you can cross reference into your ER checklist and assist in you risk assessments. This is important if your software is reliant on sensors or features of the hardware e.g. if the software controls the camera light then the ERs on radiation will apply to your software.
 
Thread starter Similar threads Forum Replies Date
G Essential Requirements Checklist - (MDD 93/42 / EEC) Misc. Quality Assurance and Business Systems Related Topics 2
C CMDR Essential (Safety & Effectiveness) Requirements Checklist? Canada Medical Device Regulations 9
N Essential requirements checklist needed? ISO 13485:2016 - Medical Device Quality Management Systems 4
K Essential Requirements Checklist references EU Medical Device Regulations 10
A Regarding Essential Requirements Checklist ISO 13485:2016 - Medical Device Quality Management Systems 9
J Essential Requirements Checklist w/o ISO 13485 CE Marking (Conformité Européene) / CB Scheme 7
S Canada - Essential Requirements Checklist for MDD 93/42/EEC Canada Medical Device Regulations 8
E Developing the Essential Requirements Checklist - Identifying Requirements Other US Medical Device Regulations 3
bio_subbu Essential Requirements Checklist for AIMDD 90/385/EEC CE Marking (Conformité Européene) / CB Scheme 2
A Essential Requirements Checklist for PPE (Personal Protective Equipment) CE Marking (Conformité Européene) / CB Scheme 6
P Essential Requirements checklist as per unrevised MDD (MDD 93/42/EEC) EU Medical Device Regulations 7
T MDD Essential Requirements Checklist in accordance with MDD 2007/47/EC EU Medical Device Regulations 3
I Essential Requirements Checklist for MDD 2007/47 Document Control Systems, Procedures, Forms and Templates 19
A Technical Agreement for the CE Mark - Essential Requirements Checklist EU Medical Device Regulations 7
W MDD (Medical Device Directive) Essential Requirements Checklist ISO 13485:2016 - Medical Device Quality Management Systems 18
K Comparison essential requirements EU compared to those of MDSAP countries Other Medical Device Regulations World-Wide 3
M Brazil and Japan - Essential requirements Other Medical Device Regulations World-Wide 3
rezayatmand IEC 60601-2-18 Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipmen IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
Rincewind Pressure energy - Essential Requirements (MDD/MDR) EU Medical Device Regulations 2
S Medical Device Changes and How to Assess Their Impacts to Essential Requirements EU Medical Device Regulations 2
K New Product Essential Requirements Cheat Sheet EU Medical Device Regulations 6
S Innovation in ER (Essential Requirements) Checklists EU Medical Device Regulations 6
E Question on approval of the EU Essential Requirements Matrix - MDD Requirements EU Medical Device Regulations 1
5 Completed Medical Device Essential Requirements Matrix CE Marking (Conformité Européene) / CB Scheme 1
S MDD 93/42/EEC Essential Requirements and Safety definition CE Marking (Conformité Européene) / CB Scheme 2
E Essential Requirements for each type of Risk EU Medical Device Regulations 11
R ISO IEC EN 62366 Usability Engineering Essential Requirements IEC 62366 - Medical Device Usability Engineering 8
M How to write the Essential Requirements EU Medical Device Regulations 14
I Essential Requirements for Medical Devices - Word copy wanted EU Medical Device Regulations 4
E Essential Requirements - Example of the essential requirements filled in ISO 13485:2016 - Medical Device Quality Management Systems 3
T Essential Requirements Of A Technical File - ISO13485 / Health Canada / MDD ISO 13485:2016 - Medical Device Quality Management Systems 6
J IVD Directive - Review and Update Essential Requirements Documentation EU Medical Device Regulations 5
T Harmonised Standard and Essential Requirements ISO 13485:2016 - Medical Device Quality Management Systems 3
D Essential performance and EMC immunity testing IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
normhowe Why is RCA essential? Problem Solving, Root Cause Fault and Failure Analysis 19
Bev D Essential References for Practical Quality Engineering Misc. Quality Assurance and Business Systems Related Topics 0
W IEC 60601 - Essential performance c.2.34 IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
C Essential Design Output(s) and Design transfer 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 11
shimonv IEC 60601-1 Essential Performance - Is the signal accuracy specification an essential requirement? IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
M Informational TGA – Essential principles checklist (medical devices) Medical Device and FDA Regulations and Standards News 2
M Informational TGA Consultation: Proposed changes to medical device essential principles for safety and performance Medical Device and FDA Regulations and Standards News 0
M Informational TGA Webinar: Essential Principles to software Medical Device and FDA Regulations and Standards News 0
B Essential Performance of a Cone Beam Computed Tomography Device IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
Z In which country is essential to have and IEC 60601 CB Report? Other Medical Device Related Standards 0
D IEC 60601-1 - Essential performance doesn't make sense IEC 60601 - Medical Electrical Equipment Safety Standards Series 10
D IEC 60601-1 - Performance limits for essential performance IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
D Essential performance, accompanying documents....confused IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
K IEC 60601-1 and Essential Performance IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
M IEC 60601 - Limits of agreement as Essential Performance IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
A Essential Requirement Checklist For Medical Device CE Marking (Conformité Européene) / CB Scheme 4

Similar threads

Top Bottom