Three ways to increase your BIMO audit readiness

Three ways to increase your BIMO audit readiness

Jul 15, 2022 | News

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...
Registry Study vs Clinical Trial

Registry Study vs Clinical Trial

Jul 6, 2022 | Events

Device manufacturers have multiple choices when it comes to post-market clinical follow-up (PMCF) activities. Two such choices are ‘patient registries’ and ‘investigator-initiated trials’, but what’s the difference? Both sound like...
IVDR – What Is A PER?

IVDR – What Is A PER?

Jun 29, 2022 | News

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

Jun 20, 2022 | News

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...
EU MDR and How We Can Help

EU MDR and How We Can Help

Jun 15, 2022 | Events

Working feverishly on your EU MDR documentation in preparation for May 24, 2024 final implementation? Well, the MDCG has just offered you some insights into how to get there. Work harder. Need help? We would love to jump in! We are a full-service consulting firm,...