Clarify if your Software is a Medical Device (SaMD)?
Monir El Azzouzi
Founder & CEO at Easy Medical Device | Consulting Firm | Podcast Host
Let me put you on stage for few seconds. One day you woke-up and you have THE idea.
“I will develop a software or an “app” (for my young audience lol) that will save lives and I will sell it quickly and I’ll become rich.”
Hold on! Let’s analyze this sentence in detail.
You will create a piece of code (Software) and with it you will do something (algorithm or analyze or prediction…) and if all goes well this can save people’s life. But if your software makes a wrong job because you misinterpreted some information, then people can die or get heavily injured. So you’ll get to jail and ruin your life.
Alarm, Alarm..!!!
It sounds like what you are trying to develop is a Medical Device.
If you are not sure just change the word “Software” by the word “Product” to see how it sounds… Yes, it’s a Medical Device.
Let’s make some arrangement to this sentence. I think you missed something but I am sure we’ll figure out what.
Let me rephrase
Ok, after some thinking, here is my proposal.
“I will develop a software or an “app” that will hopefully save lives (if this passes all the clinical studies that I will plan to do to confirm that my piece of software is really saving them) and will submit it to a Notified Body for evaluation to obtain the CE mark.
But before that I need to build my Quality Management System following the standard ISO 13485 and develop this software following the right specific standard as IEC 62304, IEC 62366, IEC 60601 (Look chapter “Quality Standards for SaMD”).
And if it will pass the certification and arrive on the market I will need to monitor the software regularly through Post-market Surveillance. For any changes that is affecting the software, should update the risk analysis that I developed following ISO 14971.
And I will get audited every year by my Notified Body. And maybe twice a year because possibly I will get an unannounced audit….. Then I’ll be happy”
Does it not sound better. I think it’s perfect. It looks like the 10 commandments to follow to develop a Medical Device Software.
“Ok, I’ll maybe not do that finally”
Why? Your idea looks really great.
You should not give up on your dream. Let me help you to clarify your path to succeed.
Regulatory Affairs and Quality Manager - Healthcare - Software as a Medical Device - Artificial Intelligence
6 年Thanks for sharing this...
European Editor at International Pharmaceutical Quality
6 年Hi Monir, I really like this article and it fits perfectly with a session we will have at the TOPRA Medical Device Symposium in Stockholm on 1st October, when we will hear from a competent authority on their perspective and guidance available, a consultant on data management issues and a company who have been incredibly successful by doing as you say - following all the regulatory requirements and at the same time telling people how useful their product is - #coalalife?(Swedish company but presenting in English!) It would be great if you can come to Stockholm to join the discussions! You can read more here: #TOPRASymposium
Industrial Engineer, technical advisor, Innovator in space and medical devices
6 年I recently rediscovered the NASA SDLC standard equivalent. ?Impressive . And free.
Founder & CEO, Passionate about designing superior products and software that are, safer, smarter and cost efficient, while giving back to the community. Speaker & technical consultant
6 年The "software as a medical device" that we have worked on has all had an AI component. This is something we discuss with people and companies right up front. The learning aspect, the gathering of data, to make better decisions, is very crucial to the overall success of the device / software. But in the end, the regression testing and everything that comes with that (documentation) could price the device out of the market.
Managing partner at MD101 Consulting
6 年Great article! I feel I'm reading my own professional life!