The field of radiology is constantly changing and evolving overtime. One MedTech innovator who's leading that charge is Schelte Post. He’s a quality manager at MR Coils, a company that has successfully developed specialized and innovative Magnetic Resonance Coils for MRI systems.
In this episode of MedTech True Quality Stories, Schelte Post shares the fascinating story of MR Coils’ journey in discovering powerful new MRI visible biomarkers, a non-invasive technology can be developed for dynamically mapping biochemical processes in the whole human body.
Through their innovative work in detecting metabolic biomarkers, MR Coils is advancing MRI technology as we know it today.
Some of the highlights of the show include:
● At MR Coils, Schelte enjoys using his background in quality and process improvement to help improve quality of life and make a difference.
● MR Coils has grown quickly. Schelte describes the company’s journey due to less competition and innovation for accessory parts for MRI scanners.
● Initially, MR Coils underestimated the amount of regulations, standards, and effort needed for compliance and to put a medical device in the marketplace.
● The biggest challenges the company has faced include setting up a design history file for each prototype and making sure changes are processed properly.
● MR Coils recently achieved the milestone of ISO 13485:2016 certification with the help of QMS software from Greenlight Guru. The company had some prior QMS experience to help prepare for an audit.
● Company’s mindset and culture of quality improves every day. Processes have been enhanced, and everyone knows what’s expected to manage risk.
● Audit: Practice what you preach and have evidence to back it up. Always have a healthy level of fear and anxiety, but be prepared and do business as usual.