Software in Medical Devices, by MD101 Consulting

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.

The draft guidance about Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices was published late January 2016.

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.

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?

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.

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

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

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.

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.