Medical Device Software Development Procedure

K

KAMay

#1
Hi

I am the Quality Manager for a medical device company and up until now I have only been concerned with ISO 9001 and ISO 13485 (and all relevant directives etc) (I'm also pretty new to quality in general so please forgive my ignorance)

I have just been asked to take on board the creation of a software procedure (the company makes everything in house from hardware to software) - however I'm not even sure where to start or what standard to buy.

I feel a little bit like a duck out of water and they're wanting this quicker than ASAP haha! :whip:

Any help with pointing me in the right direction, even just where to start would be appreciated

Thanks, Katie
 
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Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#2
Re: Software Procedure

Can you be more specific? Do you mean a software development procedure?
 

Le Chiffre

Quite Involved in Discussions
#4
Re: Medical Device Software Procedure

Hi Katie,

I'm in a similar job function :bigwave:

I was recommended by one regulator to include IEC 62304 (Medical device software -- Software life cycle processes). It's a good read. As you'll hear often, start with a gap analysis between this and your current practices, then you can address the specifics.
 

yodon

Staff member
Super Moderator
#5
Re: Software Procedure

The place to start is by defining the software development life cycle (SDLC). There are myriad models but the "V model" (google it) is pretty typical for most organizations.

Start with that and see how well (if) your company fits into that model / how to adapt that model to fit your company. Talk to the developers to get an understanding of what they (really) do.

The artifacts developed along the way become the evidence of process compliance.

Hopefully that gets you started.
 
B

blewispunk

#6
Re: Medical Device Software Procedure

I agree with Le Chiffre that IEC 62304 is a great resource for medical device software development.
 

bio_subbu

Super Moderator
#8
Hi Katie

Attached presentation is medical device software development and, you can find step by step development phases. Also, I recommend you to go through below standards

IEC 62304:2006 Medical device software - Software life-cycle processes

EN 62366:2008 Medical devices - Application of usability engineering to medical devices.

I believe that, it will be useful to you to make software development procedure.

Regards
S. Subramaniam
 

Attachments

M

Martin IT

#10
There is a list of other ISO, which could be usefull for you:

IEC 62304:2006 Medical device software – Software life-cycle processes.
ISO/IEC 12207:2008 Systems and software engineering – Software life cycle processes
ISO/IEC 15288:2008 Systems and software engineering – Software life cycle processes
ISO/IEC 15289:2006 Systems and software engineering – Content of systems and software life cycle process information products ( Documentation )
ISO/IEC TR 19760:2003 System engineering – A guide for the application of ISO/IEC 15288 (Software life cycle processes)
ISO/IEC TR 15271, Information technology — Guide for ISO/IEC 12207 (Software life cycle processes)
CEI EN 60601-1 ( 3rd edition ) annex H
 

Attachments

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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
V Software as medical device (SaMD) replicated for multiple clients through APIs IEC 62304 - Medical Device Software Life Cycle Processes 5
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 3
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F Software as a Medical Device (SaMD) Technical File Requirements Manufacturing and Related Processes 3
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) 4
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
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