SEM offers comprehensive medical device contract manufacturing services. With extensive experience in designing and manufacturing medical devices, our manufacturing facility is complaint with ISO 13485. As part of our continuous improvement philosophy, SEM has always looked for new challenges and ways to improve process and capabilities.
Medical Device Quality and Regulatory Compliance
Since producing medical devices require refinement and validation of critical processes, documentation, traceability and strict regulatory compliance, SEM has put in place a robust quality management program that ensures full compliance with the FDA’s Quality System Regulations, Europe’s Medical Device Directives and other regulatory agency requirements.
The ISO 13485 qualifications and audits have helped SEM strengthen our capabilities in addressing the stringent design, engineering and manufacturing requirements needed for our medical, as well as non-medical customers.