Medical
Our commitment to the healthcare industry
- Medical product R&D compliant to ISO 13485, from prototyping and design to production, testing, installation, and servicing.
- System architecture definition, including product requirements.
- Risk analysis based on ISO 14971, including identification, analysis, evaluation, and control of potential hazards throughout the entire product lifecycle. Emphasis on DFMEA, FTA, HAZOP, and test protocols.
- EMC/EMI plan development and execution in compliance to IEC 60601/ IEC 61326.
- Documentation, feasibility reports and development plan, and records to support DHF and FDA filing.
- Wireless coexistence planning and testing in accordance to TIR69 & C63.27.
- Developed test applications to test medical devices and patient monitors.
- Strict adherence to FDA regulations.
