Regulatory-Grade Quality Management
Your Partner in MedTech Excellence
We connect QMS, compliance, regulatory intelligence, and clinical evidence into one digital framework for MedTech success.
Why Choose Structura MedTech
Quality Management Systems (QMS) and Clinical Evidence Strategies for MedTech Companies
We design and operationalize regulatory-grade Quality Management Systems (QMS) aligned with EU MDR 2017/745 and ISO 13485:2016, prepared to be optimized for Medical Device Software including (MDSW) including Software as Medical Device (SaMD) and AI-enabled products.
We don't treat compliance as an obligation—it's a strategic asset. We build Regulatory & Clinical Evidence Strategies that connect scientific validation to reimbursement and market adoption.
Clear Regulatory Pathways
We map out exactly what you need for FDA, MDR, or other regulatory submissions—no guesswork, no surprises.
Practical Implementation
We build QMS systems that integrate with your workflow, not disrupt it. Agile, scalable, and actually usable.
Software & AI Expertise
We specialize in software-based medical devices. SaMD, AI/ML, digital therapeutics—we speak your language.
Four Pillars to Market Access
Quality Management Systems (QMS) that Scale
We build modular, scalable QMS solutions aligned with MDR, IVDR, FDA and ISO 13485 — built for MDSW, SaMD, and AI-based products with full audit readiness.
Compliance as a Competitive Advantage
We make compliance a driver of efficiency and trust — integrating risk, CAPA, and governance to achieve faster execution and lasting operational excellence.
Market Driven Regulatory Intelligence
We align MDR, IVDR, and FDA strategies with business objectives — using early authority engagement and data-driven planning to accelerate approval and market entry.
Market Driven Evidence Strategy
We design clinical evidence strategies that align with MDR/IVDR/FDA and enhance companies' reimbursement, market access, and clinical acceptance potential.
Ready to Transform Your Quality Management?
Let's discuss how we can help you build a regulatory-grade QMS that supports your medical device development and market success.