News & Events
News & Events
What’s Happening
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...
Registry Study vs Clinical Trial
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 large-scale studies after all....
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
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 important of course, but what...
EU MDR and How We Can Help
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,...
MedTech MVP Conference 2022
Our CEO, Karen Bannick McQuoid, MA, RAC, FRAPS is attending the Medtech MVP conference in Minneapolis, MN June 14-15. She is looking forward to hearing some great discussions on neuromodulation (Jill Schiaparelli , MBA, Avation Medical) and medtech clinical trials...
IVDR – putting all the pieces together
And just like that, a year has passed and we witnessed the IVDR roll-out. At the outset, IVDR may appear to be a simple guidance for IVD products, however, there are subtle nuances that help decide the regulatory strategy for these devices. Important takeaways from...
IVDR is now live, are you ready?
The May 2022 “Date of Application” for in vitro diagnostic medical devices Regulation (EU) 2017/746 (IVDR) has come and gone! Do you have a good grasp of the IVDR jigsaw for CE certification? Don’t juggle all the puzzle pieces without a strategic plan for compliance...
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...