Hello! I’m Maia Kirk, a Regulatory Affairs Executive Leader specializing in Class II/ I II medical devices and IVDs, with deep experience across FDA, EU MDR, IVDR, and Global Frameworks:

• Product Development / Design Control

• Risk Management

• IEC / ISO Compliance

• Regulatory Submissions

• Gap Assessments

• Regulatory Remediation

• QMS Modernization

• Global Expansion Strategy

I built MKRS to help organizations cut through the noise, reduce risk, and accelerate market access; removing bottlenecks, confusion, and compliance drama.

My philosophy is simple:
✨Regulation should empower innovation, not suffocate it.

Furthermore, when you work with me, you are guaranteed:

✨ Fast execution

✨ A sharp, strategic perspective

✨ Clear, timely communications

✨ Unwavering transparency

✨ And ultimately, regulatory documents so polished they spark joy!