The stakes seem high and the risk is real, but in a very large sense executing your MDR project is just another project. This is the fifth blog post in a serious on the changing European regulations in Europe. The previous four discussed what MDR is and why it is a concern, how to prioritize your devices in preparation for the new regulations, what to be thinking about as you perform a gap analysis, and finally, how to build a plan.
Phases of Project Management
A normal development project will typically have five phases, from 1) concept, through 2) development, to 3) design and process validation, and any sort of 4) product validation before you submit. Once you have approval, you 5) launch and do post-market surveillance. The shift from MDD to MDR has a few variations, but they stay consistent with these five phases.
Gap Analysis is step 1
First, return to your Gap Analysis. Do you have to redesign your product? Is there additional testing required? Or do you have to just provide more documentation? The process is the same – but it is a question of how to make that happen.
Risk Analysis
Next, revisit your Risk Analysis. Are there potential design changes to be made? If you have to do new clinical trials, are there any unexpected results to consider as a contingency? It may cause you to rethink the plan to include the corrections. Are there new risks to mitigate, or are those risks justifiable in light of the modifications to the product?
Work with regulation bodies for correct industries
One significant change is more cultural than procedural: How you work with your Notified Body. Notified Bodies were always considered an advocate to the industry. Now there is more emphasis than they confirm that regulations are being fulfilled – more auditing and policing. They have more clout. And while in the past, they may have worked with you to get your product to market, this is no longer expected to be the case. Just as you are being held more accountable, they are also being held more accountable and they will be very busy.
Back to the main theme: this is just another project; an important one, to be sure. Put good people on it and project manage the heck out of it.
Contact The Waddell Group Today
We provide strategic level project leaders for the medical device industry. Beyond essential project management skills, our highly experienced consultants know how to lead teams, manage in times of crisis, and influence change. We offer expertise, intellectual property, and proven methodology. If your in need of a team to project manage your medical device contact us or give us a call at 952.221.3333 and get started today