Software in Medical Devices, by MD101 Consulting

To content | To menu | To search

Sunday 17 June 2012

How to combine risk management process with agile software development? - Part 2

This post is the continuation of the post of last week.
We've seen in that post that fixing bugs during software maintenance is like a small chunk of design, excepted that software specifications do not change. Therefore risk management process when fixing bugs is very close to risk management process during design, without the initial assessment of risks at the beginning of the software development cycle.

Continue reading...

Saturday 9 June 2012

How to combine risk management process with agile software development? - Part 1

This post comes after a series of three posts where I exposed my thoughts about development of software medical devices with agile methods.
These posts were focussed on software development. Risk management deserves its own series of posts. Here is the first of three.

Continue reading...

Saturday 2 June 2012

How to develop medical device software with agile methods? - Part 3

In my previous post, I explained how to adapt agile methods to IEC 62304. I finish this series of 3 posts with some advices about the organization of an iteration and the software development team.

Continue reading...

Wednesday 16 May 2012

How to develop medical device software with agile methods? - Part 2

In my previous post, I explained how I tweaked the waterfall model to obtain something close to agile methods. But still not agile, actually...

Continue reading...

Saturday 12 May 2012

How to develop medical device software with agile methods? - Part 1

IEC 62304 is the standard to apply for software in medical devices. It is not bound to any software development method or model. Though not explicit, using the waterfall development model is the most straighforward way to apply this standard.
The waterfall model has become old fashioned to the eyes of most of software developers, with the emergence of agile methods. Agile methods are so popular now that everydody wonders how to apply IEC 62304 with agile methods.

An AAMI/CDV-1 TIR(SW1) - Guidance on the use of agile practices in the development of medical device software exists about this subject. But it is still a draft and only members of AAMI have access to it.

So, how to use agile methods and still be compliant with IEC 62304?
Here are my thoughts about these questionings!

Continue reading...

Wednesday 4 January 2012

Software development subcontractors: How to manage your Customer

Congratulations! You have signed a contract with a medical devices manufacturer. They don't have a very good knowledge of software. They rely on you to develop something brand new on a smartphone. The application they want to develop will bring new functionalities to doctors and let them do their jobs faster. Your customer chose you because you are the specialist of software on every OS’es on smartphones. You ensured him that your company can be in conformity with IEC 62304 standard. To that purpose, you modified and added the necessary procedures and forms to your quality system. You have one year to develop the application, which fits their desires … and the medical devices standards!

Continue reading...

Monday 12 December 2011

How to externalize software development for a medical device?

Case example

You are a medical device company and you want to replace your old products by “smart” ones. Your competitors are doing it and you customers want them. “Smart” means something like an tiny computer (its amazing how small they are), with an operating system and big software. For electronic stuff, you have your own engineers or you have your subcontractors, which you have been working for 20 years with. They knew how to design embedded software on microchips. But they don’t know how to design software of higher level, with intelligent behaviour and complex algorithms.

Continue reading...

page 2 of 2 -