Medical device manufacturing

Consonance

Poland

Service ID:

EP172S3
Service description
Consonance is an ISO 13485-certified medical device manufacturer offering end-to-end support across the full production lifecycle. We manage all stages of manufacturing, including component and supplier selection, design for manufacturing, pilot builds, and full-scale device production. Our in-house capabilities include functional and production prototypes, trial series, and monthly output of up to 5,000 fully assembled units. All operations take place within a controlled quality system and include assembly, testing, quality control, and packaging to ensure consistent device performance and full traceability. We provide complete supply chain management, covering material and component evaluation, sourcing, and the oversight of suppliers and subcontractors for specialized components. Our team maintains established processes for supplier qualification and ongoing performance monitoring. Consonance has experience producing devices in classes I, IIa, and IIb, with strong expertise in complex, electronics-driven products. Our manufacturing facility is equipped with advanced production tools, including 3D printing, CNC machining, solder paste printing, pick-and-place assembly, reflow soldering, automated test systems, and professional packaging equipment. This integrated infrastructure supports efficient, scalable, and compliant manufacturing tailored to the technical and regulatory requirements of each project.
Sector
Biotechnology
Health and medical care
Technology Readiness Level
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 Audit is €20,000. Based on the research results, we estimate a fixed-price budget to achieve the expected industrialization stage.

Disclaimer related to service

Starts with a Technical Audit 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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