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.
Complete Templates and Documentation
Receive all of our Template Word Docs to structure your submission. Our included Documentation and Instructions set are comprehensive and easy to follow.
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 clincal 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
Start With Certainty
Stuck on EU MDR Clinical Evaluations?
Stuck on EU MDR Post Market Surveilance?
Frequently Asked Questions
Will this package teach me how to conduct the Systematic Literature Review?
Yes! Much more than templates. Our guide package includes complete instructions detailing out every aspect of the review. You will not need any other instruction to conduct, write, and complete your Literature Review.
Does this include access to your CiteMed Systematic Literature Review Dashboard?
Only the Inclusive package does. This process and templates are designed to be conducted entirely on your own and no use of our software is required. If you would like to speed things up further, contact us to test drive our software.
Will you answer questions and support us during our review?
Visit my linkedin to get some clarity on broad questions you may have. If you need detailed, expert support see our inclusive packages where we offer 1 to 1 advice with a clinical evaluation expert.
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