Medical Devices
Accredited certificates with as-found / as-left data — supporting our customers' FDA and 21 CFR Part 820 quality programs.
Calibration for medical devices
Medical-device manufacturers and clinical facilities rely on accurate, traceable instrumentation — and on documentation that holds up in an FDA inspection. FCI provides calibration aligned to ISO 13485 supplier-quality expectations and FDA 21 CFR Part 820 quality systems, with clear, defensible as-found and as-left data on every certificate.
As-found / as-left documentation is a standard FCI deliverable, not an upgrade. When an instrument is found out of tolerance, the as-found record lets you assess the impact on product made since the last calibration — exactly what an FDA or ISO 13485 auditor expects to see. This is one of FCI's core competitive standards.
Why FCI for this sector
- ISO 13485 / FDA 21 CFR Part 820 alignment
- As-found / as-left data on every certificate
- FDA / GMP documentation support
- Biomedical & lab-instrument calibration
Medical Devices calibration questions
Do your certificates support ISO 13485 and 21 CFR Part 820?
Yes. ISO 13485 and FDA 21 CFR Part 820 require traceable, documented calibration, and our accredited certificates supply it, with as-found and as-left data on every certificate.
What do you calibrate for medical device makers?
Biomedical and laboratory instruments plus the dimensional, electrical, thermal, mechanical and pressure equipment used in production and test, with FDA and GMP documentation support.
What is on every certificate?
Every certificate is issued under our ISO/IEC 17025:2017 accreditation (IAS CL-112) and records as-found and as-left readings at each test point, with measured values, tolerances and expanded uncertainty at 95% confidence (k=2).
How fast is a quote?
Returning customers get a written quote within one business day. New customers and new equipment go through ISO/IEC 17025 contract review in three to five business days. We calibrate in our accredited Phoenix lab in Ahwatukee and on site at your facility. On-site calibration runs Monday to Friday, 7:00 AM to 3:00 PM, by appointment.