Service and manufacturing competence for neurostimulation systems

REQUIREMENTS AND IMPLEMENTATION

Devices for medical applications are in a strictly regulated market and are therefore subject to strict requirements. HEITEC manufactures the complete neurostimulator for one of its customers - an innovative company specializing in the research, development and manufacturing of electromagnetic stimulators. According to the customer’s specifications, the complete system integration is carried out, i.e. the boards are assembled, the complex electronics are integrated into the housing and the functionality is completely tested, so that complete systems can be delivered including an operating manual in the appropriate national language. The design is user-friendly, robust and includes potential upgrade options.

In transcranial magnetic stimulation (TMS), pulsating magnetic fields with the size of a thumb are applied in a targeted manner. The stimulation systems essentially consist of two main components: The magnetic stimulator and a treatment coil for energy transfer. Different types of coils with different pulse rates each cover special areas of application. While the basic principle and system remain the same - a single basic system can therefore be adapted individually for each area in next to no time. In order to guarantee the customer the greatest possible flexibility, HEITEC has therefore decided to prefabricate 80% of the devices, which, depending on the application, can then be quickly finalized in a second step. Volatile market movements or surprisingly high demand can thus be met as quickly as possible. The customer started as a start-up and has meanwhile developed into a global player. HEITEC has accompanied him all along the way.

As a supplier with multiple locations in Southern Germany, HEITEC offers the appropriate customer proximity and has been dealing with the consistent, efficient implementation of restrictive requirements in the development and manufacture of medical devices based on the standards EN ISO 13485, EN ISO14971 and EN 60601-1 for decades. These also apply to quality and risk management, safety, including the essential performance characteristics, and the life cycle processes of medical electrical equipment.

TECHNICAL SUMMARY

• Customer-specific housing
• Pulse energy: 160 Ws
• Magnetic fi eld: 1 Tesla (depending on coil)
• W x H x D: 490 x 240 x 570 mm
• Weight: 38 kg
• Fanless operation

CUSTOMER BENEFIT

• Realization of the customer-specific housing in the customer’s corporate design
• Safe governance of standards EN ISO 13485, EN ISO14971 and EN 60601-1
• Design and manufacturing of medical technology components and systems from a single source
• Support of the customer’s product life cycle

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