Initial Situation
A certain company from the healthcare technology sector approached TPS Elektronik with a critical compliance challenge. Their diagnostic equipment, originally developed more than ten years ago, had not been properly tested for electrical safety and could no longer meet updated national and international EMC standards.
The previous supplier had discontinued production, and the customer was left with only an outdated prototype and incomplete documentation. During initial validation, the device failed several electrical safety tests and did not qualify for CE certification.
The company needed a reliable partner to carry out complete medical device electrical safety testing, redesign its control electronics, and issue a valid electrical safety test certificate to allow re-entry into regulated markets.
The main challenges included:
- Outdated internal circuitry that no longer met electrical safety testing for medical devices requirements.
- Lack of reliable electrical safety test equipment to perform high-voltage and leakage current tests.
- No prior experience in testing electrical safety according to IEC 60601 and related national and international EMC standards.
- Missing documentation and non-compliant product labeling.
The TPS Solution
TPS Elektronik developed a complete modernization and compliance strategy for the customer’s medical device:
Redesign and System Analysis
- Conducted a detailed risk assessment and functional redesign of the power supply and insulation system.
- Upgraded the entire electronics design to ensure full compatibility with electrical safety testing medical devices requirements.
- Integrated fail-safe mechanisms and double insulation layers for patient safety.
Electrical Safety Testing and Verification
- Performed comprehensive electrical safety tests according to IEC and EN medical standards.
- Carried out complete testing electrical safety procedures, including insulation resistance, leakage current, dielectric strength, and ground continuity measurements.
- Used calibrated electrical safety test equipment to validate every production unit.
- Generated an official electrical safety test certificate, confirming the product’s compliance with global regulatory standards.
Medical Device Compliance and Documentation
- Provided in-depth medical device electrical safety testing support, guiding the customer through the CE approval process.
- Developed standard operating procedures for ongoing electrical safety testing for medical devices in serial production.
- Ensured full alignment with national and international EMC standards, including immunity and emission tests.
Training and Knowledge Transfer
- Trained the customer’s technical team on how to perform testing electrical safety using their own electrical safety test equipment.
- Delivered documentation templates for traceability and product lifecycle management.
Results
The cooperation between TPS Elektronik and the customer produced measurable and lasting results:
- Compliance achieved: The redesigned device successfully passed all electrical safety tests and EMC requirements.
- Certification obtained: The product received an electrical safety test certificate valid for European and international markets.
- Production reliability: Routine testing electrical safety was integrated into manufacturing for ongoing compliance.
- Improved quality: Updated components and insulation systems reduced leakage current by over 40%.
- Future readiness: The company can now independently perform electrical safety testing for medical devices using modern electrical safety test equipment.
Conclusion
This project highlights TPS Elektronik’s expertise in electrical safety testing medical devices and compliance engineering. By combining redesign, verification, and training, TPS Elektronik delivered a full-scale solution that enabled the customer to regain certification and re-enter the market.
From initial diagnostics to final electrical safety test certificate, the project covered all aspects of medical device electrical safety testing, testing electrical safety, and electrical safety testing for medical devices in alignment with national and international EMC standards.
Through this successful partnership, the customer achieved a modern, compliant, and reliable product — reaffirming TPS Elektronik’s role as a trusted partner for electrical safety and EMC compliance in the medical device industry.
