Three ways to increase your BIMO audit readiness

Three ways to increase your BIMO audit readiness

Clinical Managers – Do you have an upcoming FDA audit? Is your study documentation a mess? Not sure if your monitoring is adequate? Worried FDA might knock on your door sooner rather than later? Bannick has the experience and know-how to improve your team’s audit...
IVDR – What Is A PER?

IVDR – What Is A PER?

Overwhelmed by all the challenges presented by the IVDR, such as new risk classification rules, expanded clinical evidence requirements or need for notified body approval where none was required previously? Experience with the implementation of MDR for medical devices...
How to Focus on Clinical Risk Management

How to Focus on Clinical Risk Management

Clinical research requires careful attention to risk in every aspect. We’re all familiar with terms such as “Significant Risk Device,” “risks outweigh the benefits,” and “benefit-risk,” especially as risk relates to patients. This is...
Do you need a clinical audit?

Do you need a clinical audit?

Each year, FDA publishes their bioresearch monitoring (BIMO) inspection metrics from the previous year. Like clockwork, inspectional findings issued by the agency contain similar themes: failure to follow the investigational plan, inadequate monitoring, and issues...
Is Your Quality Management System Compliant?

Is Your Quality Management System Compliant?

As a medical device company, your Quality Management System is the backbone that ensures that your medical devices remain safe, effective and compliant with all applicable regulations. At Bannick, we help medical device companies align their Quality Management System...
Top 25 Women Leaders in Medical Devices of 2022

Top 25 Women Leaders in Medical Devices of 2022

Our founder and CEO, Karen McQuoid, has been chosen as one of the Top 25 Women Leaders in Medical Devices of 2022! The Healthcare Technology Report is pleased to announce The Top 25 Women Leaders in Medical Devices of 2022. With the medical device industry advancing...