Start Your MDR Project With Confidence
Anyone who has been in Regulatory Affairs for awhile knows that there is what the Regs say, and then what actually works in audits.
Over the past few years of successful MDR submissions, we have mastered both, and want to share what we’ve learned with manufacturers who are starting their MDR journey.
Save yourself some time and uncertainty by using the same (constantly updated) documents our writing team has used to collectively author and submit 300+ tech files.
Craft the perfect Systematic Review
Learn how to build and define search terms for your device.
How to choose data bases and classify articles
How to determine exactly which Databases need to be searched for the best results with your device. And get an exact decision-tree for how to read, classify, and interpret your search results.
Our Process Gets Approved
We have never had our process scrutinized or rejected by a Notified Body for concerns of thoroughness, quality, or adherence to current regulations.
All things clinical evaluation and surveillance
Our consulting clients have often found this to be the muddiest part of the MDR. Our templates take all of the guess work out and stop you wading in mud
