Medical Device & Aerospace Regulatory Compliance — Done Right.
Regulix360 helps medical device startups, small organizations, and aerospace companies build quality systems, navigate FDA and global regulations, and get to market without delays, audit failures, or costly rework.
Compliance shouldn't slow you down.
Most companies come to us after a failed audit, an FDA warning letter, or a submission rejection. We help you get ahead of those problems, and fix them fast when they happen. Whether you're building a QMS from scratch, preparing for an ISO 13485, MDSAP, AS9100D, or ISO 9001 audit, submitting a 510(k), or navigating EU MDR/IVDR, we've done it before and we know what works.
15+
Years — each consultant brings 15+ years of experience
0
Findings on certification audits
3 mo
ISO 13485, MDSAP, AS9100D, ISO 9001 built from the ground up
4
Industries — Medical Device, Diagnostics, Cosmetics & Aerospace
Three ways we work with you
Expert regulatory and quality consulting for medical device, diagnostics, cosmetics, and aerospace. From QMS builds and FDA submissions to audit support and EU MDR/IVDR compliance.
Ready-to-use QMS templates built for ISO 13485, AS9100, ISO 9001, and FDA QMSR requirements. Pre-built SOPs, work instructions, forms, and policies. Get compliant faster without starting from scratch.
Custom electronic Quality Management Systems designed for medical device and aerospace companies. Streamline document control, CAPA, NCMRs, audits, and training — paperless and fully compliant.
QMS Build & Implementation
ISO 13485, QMSR, MDSAP, MDR/IVDR, ISO 17025, AS9100D
Audit Support & Remediation
FDA warning letters, Notified body, Internal audits, Supplier Audits
FDA & MDR/IVDR Submissions
510(k), De Novo, PMA, IDE, Q-Sub, Technical File, CE Mark
Management Rep, FDA Agent & PRRC
Regulatory representative services
EU MDR/IVDR Compliance
CE Mark, Technical files, PRRC services
Aerospace QMS Compliance
NADCAP, AS9100D, ISO 13485, ISO 17025, Prime contractor audits
Not sure where to start?
Book a free 30-minute call or email us. We'll assess where you are, identify your biggest compliance risks, and tell you exactly what needs to happen next — no obligation.