DeviCE Sistemas

Technical Manager or technical guarantor

Procedures AEMPS.

Technical Manager or technical guarantor

The Technical Manager is a necessary figure to obtain the Operating Licence granted by AEMPS, and therefore, all manufacturers, importers, sterilisers and groupers of Medical Devices and In Vitro Diagnostic Medical Devices in Spain need it as part of the CE Marking process for Medical Devices.

In addition, manufacturers of customised medical devices require a Technical Manager or technical guarantor to obtain authorisation for facilities as manufacturers of customised medical devices.
The regulations allow SMEs to outsource this service by contracting the figure of a technical manager to supervise their processes to specialists. deviCE Sistemas offers this service with biomedical engineers who are experts in manufacturing processes or importing Medical Devices and Medical Devices for In Vitro Diagnostics, by directly supervising the activities of each process.

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