Regulatory compliance
Ension maintains compliance with FDA design controls (as articulated in 21 CFR 820.30) as well as ISO 13485. This includes the use of in-depth risk and reliability analysis, management, and mitigation.
Ension maintains compliance with FDA design controls (as articulated in 21 CFR 820.30) as well as ISO 13485. This includes the use of in-depth risk and reliability analysis, management, and mitigation.
