top of page
Medical Device Product Design & Development
Innovating From Prototype to Manufacturing and Regulatory Approval
Bringing a medical device to market is complex—but with the right partner, it becomes a focused, compliant, and efficient process. Our engineering team supports you at every stage, from early concept through manufacturing at our ISO 13485 facility. Whether you're building your first prototype or preparing for a 510(k), we help you move faster, reduce risk, and stay aligned with FDA expectations.
Solutions We Offer
Technology assessment & clinical problem framing to define device purpose and intended use
Technical feasibility analysis including system architecture exploration
Regulatory strategy consulting to determine device classification and FDA submission pathway
Design verification to ensure design outputs meet all product and software requirements
IEC 60601, PEMS, and applicable standards testing support per FDA regulations
Design validation services including usability studies and human factors analysis
Rapid prototyping and requirements definition for mechanical, electrical, and software subsystems
User-centered design development including early-stage industrial and UI/UX design
Risk analysis and FMEA inputs in compliance with ISO 14971 and 21 CFR 820.30
510(k), De Novo, and PMA submission support including technical file preparation and FDA communication
Design transfer documentation, IQ/OQ/PQ, and DMR creation for production readiness
Onsite contract manufacturing at our ISO 13485 facility integrating with internal/external QMS
Complaint handling system support per 21 CFR 803 and 820.198
Post market surveillance including CAPA and ongoing risk management
Product improvement and change control support for post-market iterations or updates
Device Discovery & Concept
Verification & Validation
Regulatory Submission & Manufacturing Transfer
Post Market Surveillance
Design Prototyping & Refinement
bottom of page