medical software compliance

Sleepinnov Technology is a hi-tech company that develops medical devices for the diagnosis and monitoring of patients with respiratory complications (sleep apnea, obstructive pulmonary disease, etc.). Their products are intended for healthcare professionals, commercialized in France and internationally.

In Brief

INDUSTRY: Medical

EMPLOYEES: 20

JOB CHALLENGE: Achieve demanding medical device compliance

SOLUTION

Tuleap Enterprise Silver

FAVOURITE TOOLS

  • Agile tools
  • Issue Tracking
  • Reporting
  • Git

RESULTS

  • Processes more and more standardized
  • Greater security, efficiency, and trust to their audit-related processes

Their industry challenge

Medical device design, construction, sales and maintenance is a highly regulated field and enforces us to respect and implement numerous standards. Among these, the following ones drive the day-to-day work of their development team:

  • The ISO 13485 standard which specifies the requirements for the establishment of quality management systems (QMS) in the medical device industry.
  • The IEC 62304 standard which defines the requirements for the medical device (MD) software development cycle.

In order to meet these demanding international standards, they have set up specific processes, which are, as required by the regulations, audited once a year by independent notified bodies.

The IEC 62304 standard essentially defines the applicable requirements for each step of the medical software development cycle. The standard recommends in particular the use of a V-model development process. V model various phases can be represented by the following figure.

In addition to the sequence of steps (from left to right, following the “V”), essential links exist between steps at the same horizontal level From a normative point of view, this development cycle defines essential criteria:

  • The recording, in various documents or tools, of the work carried out at each stage.
  • The traceability of these documents and their interdependencies throughout the history of a product.

What they did

Using Tuleap for ISO 13485 & IEC 62304

After doing several tests they detailed at the end of this article, they chose to rely on Tuleap to manage these processes and ensure optimal follow-up of all phases of our projects. 

From Nicolas’ experience, Tuleap main advantages in comparison with other existing tools are:

  • First, it has a large panel of tools covering the whole software development lifecycle,
  • Second, these tools are entirely configurable in order to meet the needs of any development team.

Once installed, this is how their Tuleap platform was configured:

  • One project per medical device : BlueNight Screener, BlueNight Trainer, Agil-IT, Spiri
  • Several tracking tools per project. Some are identical, while others are specific to each project, with different fields depending on the field of application.
  • Dedicated fields have also been added and sorted in order to fit with the terminology of our Quality Management System and to reinforce the traceability of every activity.
  • Their source code is also hosted and accessible directly on Tuleap, initially via Subversion, and more recently with Git.
  • Each project also contains a wiki (MediaWiki), a document manager, and a deliverables manager for commercial versions.

Their results

More confidence, security, efficiency for audit trail

Tuleap brings greater security, efficiency, and trust to our audit-related processes. 

Nicolas Gaiffe, Software Manager

Our Tuleap personalized platform allow us to have a single, easy and secure access to all the elements necessary for the development and maintenance of our software, whatever their level of advancement and maturity.

All our team members gain efficiency, security, and improved confidence. After the installation of this new system, we get a very positive feedback from external auditors. This emphasizes the value of this tool in particular in such a regulated environment.

The cross-reference system that Tuleap offers is likely one of the best examples of what this tool can bring: ensuring complete traceability at every development step.

Continuously improving towards software development excellence

Tuleap has definitely improved our daily routines of development and quality. It allows us to increase the number of software engineering tools, step by step.

This is indeed an additional interesting aspect with this platform. Tuleap enables to advance at your own particular speed. For example, you can start with a simple code version manager and a tracker, and then later adding document management tools, planning tools, etc.

The latest additions to Sleepinnov Technology have been the implementation of the Tuleap Agile Dashboard, in particular the Scrum workspace. This allows us to have a more structured work planning while guaranteeing a better fit with a small business environment. We are starting being agile while still being compliant.

This implementation is the result from a long reflection. They are in the early stages of the Tuleap Scrum implementation and still make adjustments. Once we will find our way of 

Lastly, this semester we plan to introduce the tools dedicated to Code Review (Gerrit) and Continuous Integration (Jenkins) available in Tuleap. This will complete the structuring of our development cycle, to facilitate the integration of new employees and to improve the efficiency of all team-members, to the benefit of our customers and ultimately the patients.

Traceability links, from a suggestion of functionality, to the corresponding modifications of the source code (svn # …) and to the commercial version that embeds this functionality (release # …)
Links, from a commercial version, to each artifact that describes its new features and the minor corrections that have been made

How was it before?

It took a long time to find a tool that was adapted to our needs. We’ve tested many tools and methods, had many reflections, frustrations and sometimes even had to backtrack.

It all began with a source code manager only, to which we soon added a wiki. All project information was then stored in Word and Excel files. This quickly represented a large number of files, tedious to maintain. Traceability was guaranteed but at the price of many clicks and documents. Because of this complexity, the system often wasn’t used to its full extent.

Another downside of this system was security. The accidental modification or deletion of a Word document can happen to anyone and is not always detectable. In addition, only the most recent version of the file is accessible.

Tuleap allows you to trace file accesses, to keep a history of all its transient states as changes occur, and to define different access rights for each user. All employees may have access to common general information, while certain information remain accessible to selected users only, depending on the project and people profile.

This guarantees confidentiality and considerably limits cumbersome manipulation errors. This is vital in a regulated environment: traceability must not only be ensured for on-going projects but also preserved intact over time.

Tuleap can help you too

ultricies Lorem Phasellus porta. mi, sed Sed non vulputate,