IEC 62304 software costs and time

#1
Hello everyone,

we are developing a software (SW) which will be likely be classified as class B SW.

Does anyone know how much money it will approximately cost to conduct the tests as per IEC 62304 requirements? And approx how much time it can take?

We are a small company just developing our first SW and this will be really really helpful to us.

Highly appreciate it!!!
Thank you very much
Silvia
 
Elsmar Forum Sponsor

yodon

Staff member
Super Moderator
#2
Those are only answerable if the number and complexity of requirements are known (and I presume you're talking about the software system testing and not integration or any unit testing). Further, testing, especially for a new product is not a one-time thing; usually there are failures and, depending on the robustness of your requirements, may drive requirements changes / design changes that drive further testing. Part of testing is to ensure you have adequately covered all the requirements, typically through a trace tree analysis. If you don't have any automated trace tools, that's going to be a sizeable task on its own (to manually establish the traces).

Since you posted in the FDA section, there's a guidance for what FDA wants to see in submissions (despite 62304 being a recognized consensus standard) and a guidance for overall software validation.

And pretty much everyone now wants a cybersecurity assessment (which usually involves testing).

I always recommend a non-scripted set of exploratory tests to give the tester room to assess robustness. (These often find more issues than scripted verification protocols do!)
 
#3
Thank you very much yodon, really appreciate your answer.

We have contacted some SW companies and I think that we should start performing some initial tests for being able to provide to the SW company a better idea of what our SW will require.

However, I would like to ask you if, from your experience, you could provide us with a range of prices, even if they're very naive, so our investors could have a general idea of the costs (they are insisting a lot....)


Thank you very much again!

Silvia
 
Thread starter Similar threads Forum Replies Date
S IEC 62304 - Software verification cost IEC 62304 - Medical Device Software Life Cycle Processes 3
Sravan Manchikanti Software Risk Management & probability of occurrence as per IEC 62304 IEC 62304 - Medical Device Software Life Cycle Processes 8
M IEC 62304 Software changes - Minor labeling changes on the GUI IEC 62304 - Medical Device Software Life Cycle Processes 3
P IEC 62304:2006 A1:2015 - Software from the early 1990s IEC 62304 - Medical Device Software Life Cycle Processes 4
F IEC 62304 - Segregation and communication between software items IEC 62304 - Medical Device Software Life Cycle Processes 1
B Class IIB Device - IEC 62304 Software Classification IEC 62304 - Medical Device Software Life Cycle Processes 13
M IEC 62304 - Develop an Architecture for the Interfaces of Software Items IEC 62304 - Medical Device Software Life Cycle Processes 8
A SOP for software validation of software in medical device IEC 62304 IEC 62304 - Medical Device Software Life Cycle Processes 5
D Changing software classification via software - IEC 62304 IEC 62304 - Medical Device Software Life Cycle Processes 3
D Software as risk control - Confused on one aspect of IEC 62304 IEC 62304 - Medical Device Software Life Cycle Processes 20
Y Application of IEC/EN 62304 at an advanced stage of software development IEC 62304 - Medical Device Software Life Cycle Processes 4
C Software for Medical Devices - Requirements Content for compliance with IEC 62304 IEC 62304 - Medical Device Software Life Cycle Processes 1
K IEC 62304 Amd 1 2015 - Figure 3 – Assigning Software Safety Classification IEC 62304 - Medical Device Software Life Cycle Processes 11
F FDA PMK 510(k) - IEC 62304 Software Components Segregation Other US Medical Device Regulations 3
M IEC 62304 Applicability - GUI Control Software IEC 62304 - Medical Device Software Life Cycle Processes 3
H ISO 14971 vs. IEC 62304 vs. 98/79/EC vs. ISO 13485 (Software Medical Device) ISO 14971 - Medical Device Risk Management 1
D A desperate call for help - IEC 62304 software IEC 62304 - Medical Device Software Life Cycle Processes 5
B IEC 62304:2006/AMD1:2015 Changes for Class A Software IEC 62304 - Medical Device Software Life Cycle Processes 3
K ISO 14971 and IEC 62304 - Medical Device Software House ISO 14971 - Medical Device Risk Management 9
S Software Test Report including IEC 62304 classification IEC 62304 - Medical Device Software Life Cycle Processes 4
A Requirements for Software to be CE Mark Compliant - IEC 62304 Medical Device Software IEC 62304 - Medical Device Software Life Cycle Processes 14
E IEC 62304 5.2.2 f - Installation and acceptance of device software IEC 62304 - Medical Device Software Life Cycle Processes 1
R IEC 62304 - 5.2.9 Verify Software Requirement IEC 62304 - Medical Device Software Life Cycle Processes 5
R IEC 62304 Section 5.3.6 Verify Software Architecture IEC 62304 - Medical Device Software Life Cycle Processes 4
T IEC 62304 required for CE Marking of Software? IEC 62304 - Medical Device Software Life Cycle Processes 5
S IEC 62304 Software Process Diagram IEC 62304 - Medical Device Software Life Cycle Processes 1
E Where to Buy IEC 62304 Software Life Cycle IEC 62304 - Medical Device Software Life Cycle Processes 7
C IEC 62304 conformity for 510k submission legacy product including software IEC 62304 - Medical Device Software Life Cycle Processes 2
R Software System Inputs and Outputs - IEC 62304 5.2.2 - Software Requirements Content IEC 62304 - Medical Device Software Life Cycle Processes 6
I IEC 62304:2006 Definitions - Software System, a Software Element and Software Unit IEC 62304 - Medical Device Software Life Cycle Processes 13
R How do we show our Software Develoment Life Cycle is similar to IEC 62304 Other US Medical Device Regulations 3
S IEC 62304 Clause 6. Medical Device Software Maintenance Plan IEC 62304 - Medical Device Software Life Cycle Processes 7
M IEC 62304 vs. General Principles of Software Validation IEC 62304 - Medical Device Software Life Cycle Processes 8
S One function, many devices? IEC 62304 and Medical Device Imaging Software IEC 62304 - Medical Device Software Life Cycle Processes 9
T IEC 62304 & FDA: Software Development Methodologies for Class II- DICOM device IEC 62304 - Medical Device Software Life Cycle Processes 8
sagai Process Model for IEC 62304 - Medical Device Software Life Cycle IEC 62304 - Medical Device Software Life Cycle Processes 4
T IEC 62304:2006: Medical device software SDLC- CE Vs. Fda 510(k) submission IEC 62304 - Medical Device Software Life Cycle Processes 16
B Tabular Traceability by Software Item ID - IEC 62304 IEC 62304 - Medical Device Software Life Cycle Processes 3
A IEC 62304 Software Development Plan IEC 62304 - Medical Device Software Life Cycle Processes 28
W IEC 62304:2006 Medical device software - Software life cycle processes - Issued IEC 62304 - Medical Device Software Life Cycle Processes 10
K IEC 62304 - Testing Independance IEC 62304 - Medical Device Software Life Cycle Processes 5
K IEC 62304 - Functional and performance requirements for SOUP items IEC 62304 - Medical Device Software Life Cycle Processes 2
K IEC 62304 compliance - Code reviews as part of verification strategy IEC 62304 - Medical Device Software Life Cycle Processes 5
M Risk Analysis Flow - Confusion between ISO 14971 and IEC 62304 IEC 62304 - Medical Device Software Life Cycle Processes 8
D IEC 62304 Risk Classification - With and without hardware control IEC 62304 - Medical Device Software Life Cycle Processes 2
M IEC 62304 Class A Project IEC 62304 - Medical Device Software Life Cycle Processes 15
B Clause 5.1.12 of Technical Standard IEC 62304/A1 IEC 62304 - Medical Device Software Life Cycle Processes 5
P SOUP anomaly evaluation for MMA (Mobile Medical Application) IEC 62304 clause 7.1.3 IEC 62304 - Medical Device Software Life Cycle Processes 4
P IEC 62304 - evaluation of integration and system testing IEC 62304 - Medical Device Software Life Cycle Processes 4
P Risk acceptability alignment between ISO 14971 and IEC 62304 IEC 62304 - Medical Device Software Life Cycle Processes 6

Similar threads

Top Bottom