Service and manufacturing expertise for neurostimulation systems
Devices for medical technology applications are in a strictly regulated market and are therefore subject to stringent requirements. HEITEC manufactures the complete neurostimulator for one of its customers - an innovative company specialising in the research and development of electromagnetic stimulators.
Brief technical description
- Customised housing
- Pulse energy: 160 Ws
- Magnetic field: 1 Tesla (depending on coil)
- W x H x D: 490 x 240 x 570 mm
- Weight: 38 kg
Fanless operation
Realisation
The complete system integration is carried out according to the customer's specifications, i.e. the included boards are assembled, the complex electronics are integrated into the housing and the functionality is fully tested so that complete systems can be delivered including operating instructions in the appropriate national language. The design is user-friendly, robust and includes potential upgrade options.
Transcranial magnetic stimulation (TMS) involves the targeted application of pulsating magnetic fields the size of a person's thumb. The stimulation systems essentially consist of two main components: The magnetic stimulator and a treatment coil, which is used to transfer energy. Different coil types with different pulse rates cover specific areas of application, while the basic principle and system itself remain the same - a single basic system can therefore be customised for any area in no time at all. In order to guarantee the customer the greatest possible flexibility, HEITEC has therefore decided to prefabricate 80% of the devices, which can then be quickly finalised in a second step depending on the application. Volatile market movements or a surprisingly high demand can thus be met as quickly as possible. The customer started out as a start-up and has since developed into a global player - also with the help of HEITEC.
As a provider with several locations in southern Germany, HEITEC offers the corresponding customer proximity and has been dealing with the consistent, efficient implementation of restrictive specifications in the development and production of medical devices based on the EN ISO 13485, EN ISO14971 and EN 60601-1 standards for decades. These also apply to quality and risk management, safety, including the key performance characteristics and processes for the entire life cycle of medical electrical devices.
Customer benefits
- Realisation of the customer-specific housing in the customer's corporate design
- Reliable mastery of the EN ISO 13485, EN ISO14971 and EN 60601-1 standards
- Development and production of medical technology components and systems from a single source
- Support for the customer's product life cycle
- Flexible production of different system variants
- Long-term availability and product stability
