Medical device engineering

Consonance

Poland

Service ID:

EP172S2
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.
Sector
Biotechnology
Health and medical care
Technology Readiness Level
TRL 3 – Experimental proof of concept
TRL 4 – Technology validated in lab
TRL 5 – Technology validated in relevant environment
TRL 6 – Technology demonstrated in relevant environment
TRL 7 – System prototype demonstration in operational environment
TRL 8 – System complete and qualified
TRL 9 – Actual system proven in operational environment
Financial requirements

The price of a mandatory Technical Feasibility Study is €20,000. Based on the research results, we estimate a R&D fixed-price budget to achieve expected TLR and project milestones.

Disclaimer related to service

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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