-
FDA grants MED Institute MDDT (Medical Device Development Tool) qualification
West Lafayette, IN: MED Institute obtained FDA qualification of their MDDT (Medical Device Development Tool) for virtual...
-
FDA grants MED Institute Accreditation Scheme for Conformity Assessment (ASCA)
FOR IMMEDIATE RELEASE: August 18, 2021 Colleen Tennyson MED Institute 855.463.1633 ctennyson@medinstitute.com MED Institute Receives Accreditation through...
-
The Value of an ISO/IEC 17025:2017 Accreditation
In 2004, we decided to institute an ISO/IEC 17025 quality management system designed specifically for calibration and...
-
Patient Engagement in Clinical Trials: Patient, Industry, and Clinical Investigator Perspectives
The Medical Device Innovation Consortium (MDIC) Science for Patient Input initiative has been working to promote patient-centered...
-
How does an Early Feasibility Study differ from a Pivotal Study?
An Early Feasibility Study (EFS) is performed early in the device development process to evaluate the device...
-
Hybrid Clinical Trials in the Age of COVID-19 and Beyond
We were recently invited by the orthopedic market intelligence firm ORTHOWORLD® to describe our experiences with clinical...
-
Remediation, Regulatory Compliance, and Company Culture
FDA Warning Letters are devastating – a Quality Manager’s worst nightmare – a major shock to any...
-
EU MDR Extension
Although the implementation of EU MDR has been postponed for up to one year, it will be...
-
Top 3 Challenges for Particulate Matter Evaluation
There are several safety concerns (risks) for patients who require a minimally invasive procedure. One of the...
-
Exploring the EU MDR’s Impact on ‘Legacy’ Medical Devices
Devices already legally on the market under the European Union’s (EU) Medical Devices Directive (MDD) or the...
-
Electronic Clinical Outcome Assessment (eCOA)
Electronic Clinical Outcome Assessment (eCOA) is a method of capturing outcomes data electronically in clinical trials. eCOA...
-
RAPS 2020 Convergence
RAPS 2020 Convergence is going virtual this September! We’re sorry that we won’t be able to meet...
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 2024, we received ratings of 4.98/5 points (13).