Prototyping & PoC service

Medical device engineering

Provided by Consonance · Poland

Service description

Consonance delivers end-to-end medical device engineering services that integrate electronic, mechanical, and embedded system design within a single, cohesive MedTech development program. Our multidisciplinary team includes electronic engineers, embedded software developers, biomedical specialists, and mechanical engineers with proven experience across therapeutic and diagnostic technologies. We operate under ISO 13485 certification for medical device design, prototyping, and engineering, providing a controlled and compliant development environment from concept through verification. Our in-house regulatory team supports every stage of the process, aligning technical decisions with applicable regulatory requirements and standards. This combination of engineering rigor and regulatory expertise ensures that your device is developed efficiently, safely, and in full conformity with global MedTech expectations.

Starts with a Technical Feasibility Study covering requirements analysis, regulatory compliance analysis and certification strategy, risk assessment, technical solution concept, budget and manufacturing recommendations. Stage duration: up to 10 weeks.

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