Adequate patient enrollment and retention are absolutely essential to the success of a clinical trial. A study...
Have you been issued an FDA Form 483 or Warning Letter? We can relate to how stressful...
The idea of the Early Feasibility Studies (EFS) program was first published in 2011 as a FDA...
Our multi-disciplinary team has extensive experience in medical device research and development, including but not limited to...
The requirements associated with medical device safety testing continue to increase, which has raised the bar for...
We have recently expanded our capabilities to include MRI safety evaluation of electrically active devices to our...
Dear valued clients, With the rising global concern around COVID-19, we wish to let you know that...
The European Medical Device Regulation (MDR) is a new set of regulations that will become effective May...
Our multi-disciplinary team has extensive experience in medical device simulation and testing, including but not limited to...
Compared to the Medical Device Directive (MDD) 93/42/EEC, the Medical Device Regulation (MDR) No. 2017/745 introduces a...
Understanding the classification of your medical device before CE marking is a critical step as it affects...
To maintain compliance with heightened requirements under the Medical Device Directive (i.e., recent Notified Body implementation of...
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).