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...
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...