About Structura MedTech
Vision
To be a trusted MedTech partner on the European market, bridging regulatory and clinical processes, quality systems, and digital execution - enabling safer, smarter, and faster access to innovative medical technologies.
Mission
Structura MedTech Partner unites clinical, regulatory, and system development expertise to design and implement regulatory-grade Quality Management Systems (QMS) and evidence strategies for medical devices.
We translate complex regulatory expectations into operational frameworks and cloud-based tools that make compliance efficient, traceable, and sustainable.
Principles of Operation
Connecting evidence, governance, and technology into unified systems that align with real-world business and clinical needs.
Basing every structure and process on validated regulatory, clinical, and quality principles - preparing for MDR, IVDR, and FDA review.
Documentation for clarity - linking data, documentation, and decision-making across all lifecycle stages.
Acting with professional independence in every assigned role. Quality and Regulatory functions operate to ensure that decisions are based solely on evidence, standards, and regulatory compliance, free from commercial or operational influence.
The Guide in Every Decision
Knowledge enables sound decisions and drives the ability to act with clarity and purpose.
Commitment fuels progress - it inspires curiosity, perseverance, and the will to learn.
Adaptation turns learning into better results, creating continuous improvement and lasting impact.
Founders
Founder
Born 1971. Committed to connecting early research with business need and setting the related evidence strategies since 2005. Experience from roles as: establish and leading early research, setting evidence strategies, secure generation of evidence to meet business need and building teams at different levels.
Founder
Born 1966. Committed to quality management since 1995. Experience from roles as: responsible for management systems and certifications, consultant, mentor, supervisor, project manager and CEO.
