Shellie Knights-Mitchell, PhD Founder and Principal Consultant

BLAZSMed wasn't built by accident. It was built with intention by someone who has spent her entire career at the intersection of science, precision, and purpose.

I'm Shellie Knights-Mitchell, a biomedical engineer turned regulatory writer with more than five years of specialized EU MDR clinical evidence experience. Before founding BLAZSMed, I served as Lead Medical Writer, where I authored clinical evaluation documentation across a portfolio of complex medical devices, learning firsthand what Notified Bodies look for and what makes clinical evidence actually hold up under scrutiny.

My foundation is a PhD in Biomedical Engineering from the University of Arizona, where I developed the research discipline and scientific literacy that now shapes every document I produce. I don't just write about clinical evidence, I understand it.

But credentials only tell part of the story. I started BLAZSMed because I knew there was a better way to serve manufacturers navigating EU MDR compliance, with deeper expertise, more personal attention, and a genuine commitment to getting it right.

When you work with BLAZSMed, you work directly with me. No hand-offs, no junior writers. Just focused, expert work on your compliance documentation, so you can focus on building the device.

That's not a feature. That's the point.