Who we are

Regulix360 was founded by a regulatory and quality leader with 15+ years of experience in medical device, diagnostics, cosmetics, and aerospace — across startups, scale-ups, and global corporations.

Our team holds RAPS RAC-Device, ASQ CQM/OE, and CQA certifications, and lead auditor credentials to MDSAP, EU MDR, ISO 13485, ISO 17025, ISO 14971, AS9100D, ISO 9001, and NQA-1. We are active in the quality and regulatory community, volunteering with local organizations including Regulatory Affairs Professional Society (RAPS) and the American Society of Quality Medical Device Division (ASQ MDD).

Regulix360 works with companies that need more than a checkbox approach to compliance. We take on engagements where the stakes are real such as FDA warning letters, failed audits, first-time submissions, QMS builds from the ground up, and EU MDR transitions. And we deliver results that hold up under scrutiny.

We work across medical device, diagnostics, cosmetics, and aerospace, and we bring the same standards to every engagement regardless of company size.

Industry experts you can rely on.

Certifications

RAC-Device · CQM/OE · CQA · Lead Auditor

Standards & Frameworks

ISO 13485 · MDSAP · EU MDR · IVDR · AS9100D · ISO 17025 · ISO 14971 · NQA-1

Submissions

510(k) · De Novo · PMA · IDE · Q-Sub · CE Mark · Technical Files

Industries

Medical Device · Diagnostics · Cosmetics · Aerospace

What makes us different.

  • We've been in your shoes

    Our team has held VP and Director-level roles inside medical device and aerospace companies. We understand the pressure, the timelines, and what regulators actually look for.

  • We work across the full lifecycle

    From first QMS build through post-market compliance, FDA submissions, and global registrations, we cover everything so you don't have to manage multiple consultants.

  • We deliver results that hold up

    Zero findings across multiple certification audits. ISO 13485, AS9100D, ISO 9001, and MDSAP achieved in 3 months. We don't just get you through the audit, we build systems that stay compliant.

  • Startups to global corporations

    We've worked with 3-person startups and 100+ employee operations. We scale our approach to fit your stage, budget, and regulatory needs.

Ready to work together?

Complete the form and we'll be in touch within one business day to discuss your situation and recommend the right solution — no obligation.