We were recently invited by the orthopedic market intelligence firm ORTHOWORLD® to describe our experiences with clinical...
There is much interest in engaging patients in the medical device development process, at all stages of...
FDA Warning Letters are devastating – a Quality Manager’s worst nightmare – a major shock to any...
Although the implementation of EU MDR has been postponed for up to one year, it will be...
There are several safety concerns (risks) for patients who require a minimally invasive procedure. One of the...
Devices already legally on the market under the European Union’s (EU) Medical Devices Directive (MDD) or the...
The ability to visualize a minimally invasive medical device or product during use is an important consideration...
Electronic Clinical Outcome Assessment (eCOA) is a method of capturing outcomes data electronically in clinical trials. eCOA...
New and refined technologies have allowed for novel data collection strategies in clinical trials. “Virtual” visits allow...
RAPS 2020 Convergence is going virtual this September! We’re sorry that we won’t be able to meet...
The EFS (Early Feasibility Study) process is a regulatory pathway created by FDA to facilitate the study...
There are several safety concerns for patients with metallic implants who require MRI, including magnetic forces, torques,...
OUR COMMITMENT
We are committed to consistently performing services with high quality, that deliver exceptional results, and add value to the client’s business.
For client surveys sent in the last two quarters, we received ratings of 4.98/5 points (9).