With 35 years of experience in the medical device sector, we are passionate about enhancing patient lives through cutting-edge solutions.



Our mission is to be your strategic partner in medical device/ SaMD development, guiding you through every phase of your project—from conceptualization and rapid prototyping to successful market launch.



Our commitment to excellence is reflected in our deep understanding of regulatory requirements, ensuring that all projects meet the highest quality standards.



Together, we can achieve significant progress in healthcare.



Certifications:

ISO 13485 certified,

QMS following FDA 21 CFR Part 820 and MDR

ISO/IEC62304, 60601-1, 62366,14971,



Services:

Product Lifecycle Management

Mechanical, Eletrical, and Software Engineering

Integration of complexity through Systems Engineering

Testing and Quality Engineering

Concept Design/Concept Feasibility

Design Control, Design Change, Design for Cost, Design for Manufacturing

Risk Management

Cybersecurity Management

Cost/Process Optimization