Introduction

Medical device development presents unique challenges – balancing clinical requirements, manufacturing constraints, and regulatory considerations. BRD Lucchini helps founders and companies navigate this complex landscape, transforming concepts into production-ready designs that perform reliably and support compliance.
Our focus remains on the technical and engineering aspects of medical product development, complementing regulatory affairs specialists with thorough design controls and comprehensive documentation.

What sets us apart is applying medical-grade development processes across all industries, bringing systematic risk assessment, thorough verification, and manufacturing awareness to every project from initial concept through to production implementation.

What We Help With

Concept Feasibility

Transforming clinical needs into technically viable medical device concepts with clear development pathways.

Mechanical & Mechatronic Design

Creating integrated mechanical and electronic systems that balance clinical efficacy with manufacturing reality.

Risk Assessment and Systems Thinking

Identifying and mitigating potential failure modes before they impact safety, performance, or regulatory approval.

Prototyping & 3D Printing

Accelerating development through rapid physical validation that reduces risk before production investment.

Manufacturing Support

Bridging the gap between design and production to ensure consistent quality and efficient manufacturing.

Design Documentation for Compliance

Building robust technical files that support regulatory submissions and demonstrate design control.

Our Development Process

Medical device projects follow a structured approach that ensures both technical excellence and regulatory compliance. We work collaboratively with clients to establish clear requirements at the outset, conduct thorough verification testing throughout development, and build comprehensive documentation that supports regulatory submissions.

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Who We Work With

Our medical device engineering services support entrepreneurs with innovative healthcare concepts, established medical companies expanding their product portfolio, and research institutions translating laboratory innovations into commercial applications. We work with clients at various stages, from early proof-of-concept through to production preparation, providing either end-to-end development support or targeted assistance with specific technical challenges.
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Contact Us

To discuss your medical device project, contact our engineering team.
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