We offer a comprehensive, end-to-end solution for Quality Management Systems (QMS), regulatory compliance, and process optimization tailored to the needs of medical device and aerospace companies. Our services cover everything from initial QMS development, manufacturing process optimization, certification or accreditation, regulatory approvals and submissions, and audits.
Whether you’re a startup building a foundation or an established company optimizing compliance, we provide customized, cost-effective solutions to streamline operations, meet industry standards, and accelerate market entry. With Regulix360, compliance is simple, and quality is assured.
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Regulix Consulting
Regulix Consulting offers specialized consulting services for medical device and aerospace companies, helping you navigate complex quality and regulatory requirements with ease. From compliance audits to regulatory submissions, risk management, and manufacturing readiness, we provide tailored, cost-effective solutions to ensure your success.
Regulix Consulting also specializes in building Quality Management Systems (QMS) from the ground up, tailored to meet medical device and aerospace industry standards. Whether you're a startup establishing your first QMS or an existing company optimizing compliance, we provide custom-built systems and full implementation support to ensure seamless certification and accreditation to ISO 13485, AS9100, or ISO 9001.
Regulix QMS
Get up and running quickly with Regulix QMS ready-to-use QMS templates, designed to meet ISO 13485, AS9100, ISO 9001, and FDA requirements. Our pre-built, customizable templates cover SOPs, work instructions, forms, and policies, making it easy for startups and growing companies to establish a compliant Quality Management System without the hassle of starting from scratch. Save time, reduce costs, and achieve seamless certification with our proven frameworks.
With Regulix QMS, your QMS is scalable, compliant, and built for long-term success.
Regulix eQMS
Regulix eQMS can design and implement custom electronic Quality Management Systems (eQMS) tailored to the unique needs of medical device and aerospace companies. Our scalable, cloud-based solutions streamline document control, change control, CAPA, NCMRs, audits, training, and compliance tracking, ensuring your QMS is efficient, paperless, and fully compliant with industry standards like ISO 13485, AS9100, ISO 9001, and FDA regulations.
Whether you're building a QMS from the ground up or transitioning from a manual system, our eQMS platforms provide automation, helping you reduce costs, and improve efficiency.
Ready to Streamline Your Quality and Regulatory Processes?
Book a call with Regulix360 to discuss your specific needs and find the best solution for your business.
About Us
At Regulix360, we specialize in quality and regulatory compliance solutions for the aerospace and medical device industries, helping companies navigate complex requirements with efficiency and confidence. With over 15 years of experience working with startups to mid-sized companies, providing tailored Quality Management Systems (QMS), regulatory consulting, and compliance support to ensure seamless certification and market access.
Our experience includes experts in ISO 13485, ISO 9001, FDA 21CFR, MDD/MDR, In Vitro Diagnostics (IVD), Medical Devices, Cosmetics & OTC. ISO 9001/AS9100 and NADCAP Accreditation (Chem Processing, Materials Testing, Non-Destructive Testing).
Whether you're building a QMS from the ground up, optimizing existing processes, or preparing for audits and certifications, we offer customized, cost-effective solutions to meet your specific needs.
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