emka MEDICAL can offer services for regulatory and development of medical devices.
By history we are involved in sensor system development and manufacturing for healthcare. We started with pressure sensors and flow measurements, later also going for impedance measurements to measure for example specific components of whole blood. We have extensive experience in the fields of sensors and electronics for medical devices, injection molding, sterile products and production and all regulatory and quality management aspects relating to these. Due to the complexity of sensing systems for physiological parameters, emka MEDICAL has extended its scope in the quality management certificates from pressure sensors and related accessories to:
- Data logger for recording of physiological parameters
- Telemetry units for transferring of physiological parameters
From this established scope emka MEDICAL can offer hands-on regulatory services and development services to relevant projects for commercial applications, also for mobile health. We welcome such requests. The complexity of the potential projects needs a first careful evaluation before we can propose CE conformity pathways and referred quotations. As well after certification responsibilities need to be defined.