There is a wide range of diagnostics and medical devices being manufactured and developed, but all of these devices such as blood sugar meters or x-ray machines, need to be validated. Patients’ lives depend on it. PSC Biotech will ensure that your facility or equipment performs according to FDA requirements as indicated in 21 CFR 820. We employ a systematic approach in validating and auditing the systems you need to meet the regulations.
If you would like more information, get in contact with us directly here.