PROJECTS | Medical Technology
Technology know-how and knowledge of laws, standards and regulations. Micropool mainly implements projects in laboratory automation, analytics and diagnostics (in vitro diagnostic). Our emphasis in the medical technology lies in the development of sensors, measuring and diagnostic instruments.
Micropool is certified according to the newest standard ISO 13485 and is familiar with the special requirements applicable in medical technology:
- – guarantee of product security
- – fulfillment of the legal demands, standards and regulations
- – risk management and risk analysis according to ISO 14971
- – traceability in production
- – process and product validating and documentation
- – filing of all relevant documents
Successfully Implemented Medical Projects
Realization
Special challenge
- – high reliability
- – risk analysis (FMEA)
- – user friendly design and man-machine interface
- – easy to operate
- – low cost design
Realization
Special challenge
- – Hardware with low current consumption
- – customized display (LCD)
- – low cost design for large-scale production (4 m pcs/year)
- – risk management according to ISO 14971, test plan, verification,
validation - – documentation for certification process
Realization
Special challenge
- – high measuring accuracy
- – low power design
- – safety against data abuse and fraudulent manipulation
- – low cost, disposable product
- – ramp up production in Asia
Realization
Special challenge
- – development activities according to client‘s development process
- – functional security (reliability) to be in compliance with
programmable, medical instruments - – risk management (FMEA, verification, validation)
- – documentation according to applicable regulations
Realization
Special challenge
- – user interface for simple usability
- – customized display (LCD)
- – design in accordance to EMC-regulations
- – supplier evaluation and production, assembling and function tests
- – documentation for certification process