Structura — Structured Solutions for Complex Projects
Structura provides strategic project consulting and management services, specializing in the medical device field. Whether launching a new product, scaling operations, or navigating complex challenges, Structura helps you stay on track and deliver real results.
About Us
Structura is a strategic project consulting practice with a strong engineering foundation and specialized expertise in the medical device industry. With experience across R&D, Quality, Regulatory Affairs, and Operations, Structura supports organizations in planning and executing complex projects with precision. By combining a structured approach with deep cross-functional insight, clients receive tailored support to deliver results efficiently, compliantly, and on time.
Services
Medical Device Project Consulting
Structura offers expert guidance on projects involving innovative technologies, with a focus on creativity, simplicity, and full compliance with EU MDR, MDSAP, ISO 13485, and FDA 21 CFR 820.30 regulations.
Pre-Submission Consulting
Preparation and review of critical documentation, including: Risk assessments, Laboratory testing results, Biocompatibility certifications, pre-clinical & clinical trial reports, Clinical evaluations, Verification & Validation (V&V) packages
Regulatory & Quality Compliance
Comprehensive support for building and maintaining Quality Management Systems aligned with ISO 13485, MDSAP, and FDA 21 CFR Part 820 requirements.
Process & Documentation Support
Tailored strategies to streamline documentation, optimize processes, and align teams for regulatory readiness and successful submissions.
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Contact Us
Let’s Talk About Your Next Project
Have a question or want to discuss how Structura can support your next medical device initiative? Reach out to us, and we’ll get back to you shortly.
Ready to Tackle Your Next Project with Confidence?
At Structura, we specialize in managing complex medical device projects with precision, compliance, and results that matter.
Let’s move your project forward.
Insights
Discover expert articles, regulatory updates, and proven strategies to help you navigate the evolving landscape of the medical device industry.