System Level Qualification
- ISO13485: Compliance with these certifications underlines our commitment to ensuring reliable quality management systems in the field of medical devices (ISO13485).
- Certification Expertise: Our team specializes in obtaining certifications like UL, FCC, or CE approvals, essential for demonstrating compliance with international safety and performance standards.
In-House Testing
We combine in-house capabilities with external expertise to provide comprehensive testing and certification services.
- EMC Certification: We carry out pre-certification of electromagnetic compatibility (EMC) in-house, ensuring that potential problems are identified and rectified at an early stage. The final certification is carried out by proven external laboratories.
- Temperature and Climate Testings: Our in-house facilities are ideally equipped to carry out temperature and humidity tests, which are crucial for assessing the shelf life and reliability of products under different environmental conditions.
Documentation and Compliance
Ensuring full compliance with industry standards and regulations is a top priority within our service to our clients.
- Creation of required Documentation: To ensure a smooth and efficient certification process for our customers, we prepare and manage all required documentation.
- Cooperative approach with external labs: In close cooperation with external laboratories, we extend our qualification services to include special tests or certifications for specific market and product requirements.
Our qualification services are an integral part of our R&D portfolio. Through reliable certification support, in-house testing capabilities and thorough documentation, we ensure that our customers' products not only meet but exceed the required standards. Our commitment to quality and compliance, driven by the needs of our diverse customer base, is fueled by passion and the goal of making our customers' visions possible.
