Risk Management – part of a Quality Management System?

Risk Management is a key and mandatory part of a medical device development process.

Unfortunately, Risk Management is often treated as merely an exercise required to achieve compliance rather than a tool to achieve an optimum design and to ensure the safety of the medical device.

Let’s see how to get the best out of it:

1) Start early. Even before the actual development starts. Identify the hazards and carry out a comprehensive research though literature, white papers, complaint databases, reports of adverse events, etc.

2) Involve the whole team. For larger project all the different disciplines will have to provide inputs to the process. Include people external to the project to add a different view to the risks.

3) Capture everything. The vast majority of the risk mitigation actions are already in the minds of the developers and designers; they are already planning to have them in the product. Take credit for them.

4) Document decisions, activities, rationales, anything related to risk management activities. You will soon forget how you came to a certain decision when you have hundreds on the plate.

5) Ensure that all risk mitigation actions are traced to requirements. There is nothing worse than an item getting lost in the system and an auditor finding it.

6) Participate in meeting, discussions, technical reviews. You will be able to pick up risk mitigation strategies during the discussions between the different members of the team. This is valuable information that they are providing for free, without having them sit around a table, looking at endless spreadsheets.

If you and your company are relatively new to the risk management process, do not despair!

Ultimately, the Risk Management has the objective to make the development team think about two key questions:

1) Have we captured everything?

2) Have we done enough?

If you can answer “Yes” to both of them and you feel confident to defend your decisions in front of an auditor (and you have well documented all of this), then you have probably done a good job.

Did you know that about 25-30% of a developer’s time is devoted to generating the documents for regulatory audits in each medical device software project alone?

We help medical device companies fast-track the development of their Quality Management System and automate their compliant Risk Management with the help of our Atlassian add-ons for Confluence and JIRA.

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