A medical device remediation can be cumbersome to implement. When you’re up against a tight deadline like the EUMDR, it becomes an even bigger weight on your shoulders. You need an approach that is comprehensive, but also efficient. Impactful, but quick. Where do you start? A gap assessment.
A gap assessment is your roadmap to resolution. It outlines the steps you need to complete to be compliant and identifies the talent you need to do it, all while prioritizing tasks and building a timeline. Here’s a high-level overview to get things going.
Outline of a strong gap assessment.
- Identify device's risk class. This allows you to determine whether or not a conformity assessment is required, which is done by a Notified Body.
- Break down regulations and actions needed to be compliant as they apply to your business and products. Prioritize these actions to create workflow. Find out what areas require additional information to complete a comprehensive assessment.
- Brief stakeholders on the information gathered. This team should be cross-functional and include members across the business, not just regulatory or quality. An engineer and a manufacturing expert should always be incorporated.
- Determine positions and skillsets needed to execute outlined actions. Now that you have a keen understanding of your team’s expectations, it’s time to outline your business needs as they relate to the job at hand.
- Refine and re-rank priorities with stakeholders. This ensures that you’re being efficient in your hiring efforts by only bringing the people you need on board when you need them.
- Staff up your workforce to implement remediation actions. This is where we can help. We’ve got a database of qualified candidates with remediation experience ready to get to work.
Once you’ve completed these six steps to a successful gap assessment, you’re on your way to a successful medical device remediation!