Medical Device Development
Design for Regulatory Compliance
Medical devices must be safe, effective, and meet strict regulatory standards. Landi’s here to help translate clinical needs into compliant, manufacturable designs by integrating risk management, biocompatibility considerations, and FDA/ISO requirements from the start. Whether you're preparing for 510(k) submission or CE marking, expert guidance ensures your design aligns with regulatory expectations—without costly redesigns down the line.
Prototyping & Design Transfer for Manufacturing
Bridging the gap between concept and production requires more than just a working prototype. Our engineering team refine early designs for real-world manufacturing, considering factors like assembly feasibility, sterilization, and material selection. They also support the design transfer process, creating documentation, test plans, and DMRs (Device Master Records) to ensure a smooth handoff to manufacturing partners and contract manufacturers (CMOs).