Medical device manufacturing

Consonance

Poland

Service ID:

EP172S3
Service description
Consonance is an ISO 13485-certified medical device manufacturing company. We can assist you in your project by managing the entire production process of your device, from component and supplier selection to design for manufacturing and the actual production of your device. Our in-house production capabilities include mass production of up to 5,000 device units per month (final assembly, testing, quality control, packaging), production of trial series development and production of functional prototypes and production prototypes of medical devices, supply chain management, material and component selection and sourcing selection, auditing and management of suppliers and subcontractors for specialised components. We have a track record in the production of medical devices for classes I, IIa, and IIb. We have an in-house manufacturing facility equipped with a 3D printer, a CNC machine, a solder paste printer, a pick & place machine, a reflow soldering oven, automated test equipment, a foil wrapping machine, and other production devices.
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

Technical Audit covering requirements analysis, regulatory compliance analysis, risk assessment, technical solution concept and manufacturing recommendations including BOM. Stage duration: up to 10 weeks. Price is 15 k Euros. Based on the research results, we estimate a fixed-price manufacturing budget to deliver the number of units required by the business plan.

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Access to Infrastructure & R&D Support

Application Period:
N/A, as the service is upon demand and open on a continuous basis.
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