Medical Device Software Risk Analysis

indubioush

Quite Involved in Discussions
#1
Hello. Hoping I can get some help here. I currently work for an IVD company that has firmware, software, hardware, and a consumable in its device system. My question is whether I should do a software-only FMEA or if software associated risks can just be incorporated into another FMEA. I previously worked for an implantable device company, and there we did a design fmea, use fmea, and process fmea. Then I am used to a hazard analysis document that ties them all together. What is the norm for a device with software?

Thanks!
 
Elsmar Forum Sponsor

Ronen E

Problem Solver
Staff member
Moderator
#2
I don’t think that there’s “a norm”; if you meet ISO 14971 you’re on a pretty good track.
Disclaimer: I’m not a software expert.
 

mihzago

Trusted Information Resource
#3
If you have separate teams that each want to own respective fmea, then having them separate makes sense. If you combine software into other documents, that's fine too.
It'll depend on your organization and complexity of the product.

Whatever you decide, as long as the software is covered, you're good.
Make sure, however, that both fault and normal use is considered, and that hazards and sequence of events from the different areas are tied together.
 

yodon

Staff member
Super Moderator
#4
Agree with the previous posts - there's no standard approach. We normally do a software FMEA just because it's easier for us to keep separate. (Note: the firmware should also be addressed!). IEC 62304 provides good guidance for the software-centric risk analysis. And while the standard may not be applicable for your IVD, IEC 60601-1 has a "PEMS" section that has some good hazard considerations for software / firmware.
 

cwilburn

Starting to get Involved
#5
Many companies do a device hazards analysis that considers the system as a whole and includes software. Then, as design and development progress, they do additional hazards analysis that are more component based, like a software hazards analysis. Tools like FMEA and FTA can be used, but it is important to remember that they are tools that feed into the hazards analysis and do not suffice as the hazards analysis alone. As @mihzago mentioned, you must consider sequences of events arising from both, fault conditions and non-fault conditions.
 
Thread starter Similar threads Forum Replies Date
R Medical Device Software Certification IEC 62304 - Medical Device Software Life Cycle Processes 1
Q Storing and developing SAMD (Software as a Medical Device) in the Cloud IEC 62304 - Medical Device Software Life Cycle Processes 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
A Software as Medical Device (SaMD) definition and its applicability Other Medical Device and Orthopedic Related Topics 4
T First 510(k) submission - Class II software as medical device US Food and Drug Administration (FDA) 1
Z Software Library - could it be a medical device? ISO 13485:2016 - Medical Device Quality Management Systems 5
M Informational TGA – Submissions received: Regulation of software, including Software as a Medical Device (SaMD) Medical Device and FDA Regulations and Standards News 1
D Requirements for the dimensions / color of medical device labels - Software as a Medical Device IEC 62304 - Medical Device Software Life Cycle Processes 2
D Software as an accessory to a Class I medical device EU Medical Device Regulations 4
R Medical device software without user interface Other Medical Device and Orthopedic Related Topics 3
R Validation of Medical Device Hardware containing Software - How many to Validate ISO 13485:2016 - Medical Device Quality Management Systems 1
Ed Panek Rule 11 Question - CE approvals for software as well as the medical device EU Medical Device Regulations 6
D IEC 60601 for a Software only Medical Device? IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
S Software Release Note - Class A stand alone software medical device IEC 62304 - Medical Device Software Life Cycle Processes 2
M Professional Use Medical Software French Labeling for Canada -- Not Considered Medical Device Canada Medical Device Regulations 2
S Medical Device Software Distribution for a CE-marked medical device via a USB memory stick EU Medical Device Regulations 8
M Informational TGA – Webinar: An update on the consultation for the Regulation of Software, including Software as a Medical Device (SaMD) Medical Device and FDA Regulations and Standards News 0
J Qualification of a Software as a Medical Device (SaMD) guidance under MDR EU Medical Device Regulations 9
P Software requirement and design specifications - Medical device contains both hardware and software IEC 62304 - Medical Device Software Life Cycle Processes 2
M Informational TGA Consultation: Regulation of software, including Software as a Medical Device (SaMD) Medical Device and FDA Regulations and Standards News 0
N Medical Device Accessory Classification - Software as a Medical Device Other Medical Device Regulations World-Wide 5
R SaMD - Software as a Medical Device - Software change control form ISO 13485:2016 - Medical Device Quality Management Systems 3
G EU MDR 2017/745 Rule 11 interpretation - Re-classification of a Software as Medical Device Other Medical Device Related Standards 0
M Medical Device News TGA – Regulation of Software as a Medical Device Medical Device and FDA Regulations and Standards News 0
S Two Questions about Medical Device Software 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
K Medical Device Software Update in Field of AIMD IEC 62304 - Medical Device Software Life Cycle Processes 1
M Medical Device News Health Canada - Scientific Advisory Panel on Software as a Medical Device (SAP-SaMD) - Record of Proceedings – January 26, 2018 Canada Medical Device Regulations 0
R Online / Cloud Based Software as Medical Device EU Medical Device Regulations 8
S DMR (Device Master Record) for Medical Device Software IEC 62304 - Medical Device Software Life Cycle Processes 3
S Labelling in Medical Device Software IEC 62304 - Medical Device Software Life Cycle Processes 8
S What is considered the complete software medical device? Medical Information Technology, Medical Software and Health Informatics 6
JoCam Medical Device Software - Apps which can control medical devices EU Medical Device Regulations 13
L Software Medical Device - 7.3.8 - Design and Development Transfer ISO 13485:2016 - Medical Device Quality Management Systems 4
A SOP for software validation of software in medical device IEC 62304 IEC 62304 - Medical Device Software Life Cycle Processes 5
K Registering a Software medical device (SaMD) in China China Medical Device Regulations 5
N Medical Device Software - Switch from Waterfall to Agile methodology Medical Information Technology, Medical Software and Health Informatics 4
V Software medical device labelling EU Medical Device Regulations 5
S If a piece of software receives approval as part of a medical device system Canada Medical Device Regulations 5
C Controlling Software Versions that are part of a medical device IEC 62304 - Medical Device Software Life Cycle Processes 2
S Cloud-Based Stand Alone Software - Software Medical Device (Class II) US Food and Drug Administration (FDA) 2
Q QMS Software for Startup Medical Device Company Other Medical Device and Orthopedic Related Topics 7
B CQC oversight of Medical device software? EU Medical Device Regulations 3
H Identifying Guidance on Medical Device Software Level of Concern for the EU EU Medical Device Regulations 2
B Is IEC TR 80002-1:2009 applicable to stand-alone medical device software? ISO 14971 - Medical Device Risk Management 1
H ISO 14971 vs. IEC 62304 vs. 98/79/EC vs. ISO 13485 (Software Medical Device) ISO 14971 - Medical Device Risk Management 1
T Are internally found Medical Device Software "Bugs" Complaints? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
K 510k "Premarket" Submission for Existing Class II Software Medical Device US Food and Drug Administration (FDA) 3
P UDI Registration - Class II Medical Device Software Other US Medical Device Regulations 9
D Medical Device Software Tool Validation - Compilers! IEC 62304 - Medical Device Software Life Cycle Processes 7

Similar threads

Top Bottom