Technical Manager or Guarantee Technician
What are the responsibilities of the Technical Manager?
What are the responsibilities of the Technical Manager?
The Technical Manager is a mandatory figure to obtain the Operating License granted by the AEMPS. Therefore, all manufacturers, importers, sterilizers and groupers of Medical Devices and In Vitro Diagnostic Medical Devices in Spain must have one as part of the CE Marking process.Similarly, manufacturers of custom Medical Devices need a Technical Manager or guarantee technician to authorize their facilities as accredited manufacturers.The regulations allow SMEs to outsource this service by hiring a qualified Technical Manager. The AEMPS requires this figure to have an appropriate university degree according to the products they supervise. At deviCE Sistemas (Vitoria-Gasteiz), we offer this service with specialized biomedical engineers in manufacturing and import processes of medical and in vitro diagnostic devices, ensuring direct supervision at each stage of the process.Additionally, the AEMPS establishes that the availability of the Technical Manager must be accredited through a formal contract, reflecting sufficient dedication for the proper fulfillment of their functions.
Are there incompatibilities to be a Technical Manager?
At deviCE Sistemas we can assume the functions and responsibilities of the Technical Manager, which include (among others):Direct supervision of manufacturing, importation, grouping, and/or sterilization activities.Verification of regulatory compliance of manufactured, imported, grouped, or sterilized products.Management and control of the documentation archive of marketed or serviced products.Incident evaluation and coordination of the surveillance system, with communication to health authorities.Liaison with health authorities and presentation of the required documentation.Preparation and supervision of commercialization or servicing communications of class IIa, IIb, and III medical devices, as well as in vitro diagnostic products included in Annex II and for self-diagnosis.Preparation and presentation of documentation for the registration of medical device managers in the market, including:Class ICustom-madeCE marked groupingsSterilization of CE marked groupingsSterilization of non-sterile products for subsequent useIn vitro diagnosticsApplication for health authorization for clinical investigations.