Software in Medical Devices, a blog by MD101 Consulting

To content | To menu | To search

Tag - development process

Entries feed - Comments feed

Friday 1 July 2016

How to validate software development tools like Jira or Redmine?

Following the discussion on ISO/TR 80002-2 and AAMI TRI 36 in the previous article, here are some tips on how to validate workflow and data management software like Jira or Redmine.

Continue reading...

Friday 8 April 2016

IEC 82304-1 - Consequences on agile software development processes

Continuing our series about IEC 82304-1, let's see the consequences of this standard on agile software development processes.

Continue reading...

Friday 5 February 2016

New FDA draft guidance on interoperable medical devices

The draft guidance about Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices was published late January 2016.

Continue reading...

Friday 18 December 2015

IMDRF final document: Software as a Medical Device (SaMD): Application of Quality Management System

The IMDRF published in October 2015 the guidance document titled "Software as a Medical Device (SaMD): Application of Quality Management System" in its final version.

Continue reading...

Friday 3 October 2014

Content of DHF, DMR and DHR for medical device software - Part 1 DHF

After a temporary absence, I'm back on the waves with a new series of articles to talk about the files required by the 21 CFR 820 regulations:

  • DHF: Design History File,
  • DMR: Device Master Record,
  • DHR: Device History Record.

Let's begin with the DHF.

Continue reading...

Friday 11 April 2014

Validation of compiler and IDE - Why, when and how to? - Part 3

Coming back to the discussion about validating compilers and IDE, here are a few more comments I have on this topic.

Continue reading...

Friday 28 March 2014

Validation of compiler and IDE - Why, when and how to? - Part 2: compilers

We saw in the last post how to validate a software development tool. But we saw also that validating a compiler this way is not a satisfactory task.
Then: Why, when, and how to validate a compiler?

Continue reading...

Friday 14 March 2014

Validation of compiler and IDE - Why, when and how to? - Part 1

Validating the compiler used in software development is a recurring issue. To what extent a compiler should be validated, when, how and why?
In the same vein, we can extend the question of validation to all tools used in the software development environment: integrated development environment, configuration management tools, compiler (and linker), automated test tools.

Continue reading...

Friday 28 February 2014

Goto Fail

If you've haven't heard about Apple's security flaw registered as CVE-2014-1266 on apple website, you probably were on planet Mars.
Basically, it was unsafe to use https connections. I couldn't help but write an article about this!
Components dealing with secured connections are abolutely critical. Applying rigorous development process is the best chance to avoid any trouble with these components.

Continue reading...

Tuesday 3 December 2013

How to develop a smartphone App to be FDA-cleared or CE Marked? - part 2 IEC 62304 and agile methods

In the last article we've seen the consequences of regulations on Apps, which run on smartphone or - more broadly - on mobile platforms.
Today, let's have a look at the main standard to apply when developing software for medical devices: IEC 62304, and the context in which most people want to apply it: agile methods.

Continue reading...

Friday 18 October 2013

Template: new Software Configuration Management Plan

A new Software Configuration Management Plan (SCMP) Template, more adapted to agile methods.

Continue reading...

Friday 11 October 2013

How to validate a software medical device running on web browsers?

Your company develops medical web apps (HTML/JS, HTML5 or any other client-side technology) and your customers would like them to run on every web browser.

Web browsers are SOUP, according to IEC 62304. In case of Chrome and Firefox there are dozens of versions...

Does it mean that software has to be tested - and documented - with every single browser and every single version of the browser?
That's a nightmare!

Continue reading...

Friday 13 September 2013

Templates STP - STD and STR updated

Here is an update of Software Test Plan, Software Test Description, and Software Test Report templates.

Continue reading...

Friday 6 September 2013

Templates SAD and SDD updated

Here is an update of System Architecture Description template and Software Detailed Design template.

Continue reading...

Friday 5 April 2013

MD and IVD standards: IEC 60601-1 and IEC 61010-1, versus IEC 62304 - Part 1

Manufacturers of medical devices often ask themselves the obvious question:
Is it mandatory to be compliant both with IEC 60601-1 and IEC 62304?

Similarly, manufacturers of in vitro diagnosis devices ask themselves:
Are my devices in the scope of IEC 62304?

Obviously, medical devices (MD) with electric or electronic components are in the scope of IEC 60601-1. And in-vitro diagnosis devices (IVD) with electric or electronic components are in the scope of IEC 61010-1.

Do MD and IVD that embed software, fall in the scope of IEC 62304?
This is not so obvious.

Continue reading...

Friday 1 March 2013

How to bring legacy software into line with IEC 62304? - part 2

We've seen in the last post how to manage changes in legacy software. Let's see it from another point of view: the type of legacy software.

Continue reading...

Friday 22 February 2013

How to bring legacy software into line with IEC 62304? - part 1

Most of medical devices manufacturers have legacy software that was not designed according to IEC 62304. The devices that embed legacy software were once verified and validated. These devices and their software work well and no major adverse event were raised by software issues.
But one day, the manufacturer decides that it's time to bring that legacy software into line with IEC 62304, to align the technical file of that software (or the contribution of software to technical file content) with up-to-date standard or regulatory requirements.

Continue reading...

Friday 18 January 2013

Class A, B and C. When to do detailed design of software medical devices?

In my last post, I explained what criteria should be taken to define the level of details of software units in a software design. This activity is not mandatory for all levels of risk of software in medical devices, though, according to IEC 62304.

Continue reading...

Friday 30 November 2012

En route to Software Verification: one goal, many methods - part 1

Software verification is easy to define: to demonstrate that software works as it was specified (and without bugs!). But there's not a unique way to do it.
Let's see what methods we have in hands to verify software.

Continue reading...

Friday 16 November 2012

V&V: verification & validation, doing it right.

Writing about V&V in two previous posts, I had a lot of comments from people on a well-known social network. They made corrections to my view of V&V and brought their own definitions.
Here is an excerpt of their comments.

Continue reading...

- page 1 of 2