At Regulix360, we specialize in providing comprehensive quality and regulatory compliance solutions for medical device and aerospace industries. We help companies navigate complex regulations, streamline processes, and achieve compliance with efficiency and confidence. With over 15 years of experience, we have worked with startups to mid-sized companies, delivering tailored Quality Management Systems (QMS), regulatory consulting, and compliance support to ensure seamless certification and market access.

Industry Experts You Can Rely On

Our team of seasoned professionals brings deep expertise across multiple industry standards and regulatory frameworks, including:

✔ ISO 13485 – Medical Devices QMS Compliance
✔ ISO 9001 & AS9100 – Aerospace & General Quality Standards
✔ FDA 21 CFR – U.S. Regulatory Compliance for Medical Devices
✔ MDD/MDR – European Union Medical Device Regulations
✔ In Vitro Diagnostics (IVD) – Compliance for In Vitro Diagnostics
✔ Cosmetics & OTC Products – Regulatory & Quality Assurance
✔ NADCAP Accreditation – Chem Processing, Materials Testing, Non-Destructive Testing (NDT)

With hands-on experience across these critical areas, we help you mitigate risks, improve efficiency, and achieve long-term compliance success.

A Tailored, 360-Degree Compliance Solution

At Regulix360, we understand that no two businesses are alike. That’s why we offer an end-to-end 360 solution—whether you’re building a QMS from the ground up, developing a regulatory strategy, optimizing existing processes, or preparing for audits and certifications, we develop customized, cost-effective solutions to fit your specific needs.

Let’s connect and discuss how we can help your business succeed!