Registry Study vs Clinical Trial

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...
EU MDR and How We Can Help

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

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

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?

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...
Conference and Event Lineup

Conference and Event Lineup

Bannick LLC starts off with our first 2022 industry event at the #MedicalAlley Annual Dinner tomorrow evening, May 12, 2022, at the US Bank Stadium in Minneapolis, MN.Be sure to stop by our booth and visit with Karen Bannick McQuoid, CEO and Stefanie Koenig, Director...