Industry
Calibration for Medical Device Manufacturers
Medical device quality managers need a calibration supplier whose evidence survives a notified-body audit and an FDA inspection — not just a sticker and a pass. Our A2LA-accredited certificates document as-found/as-left data, measurement uncertainty, and unbroken NIST traceability, which is exactly what a supplier-qualification file and a measurement-control procedure need to reference.
Standards & regimes we support
- ISO 13485
- FDA 21 CFR Part 820
- Notified-body audits
- ISO 14971 (risk)
Evidence that holds up under inspection
ISO 13485 and FDA 21 CFR Part 820 both require that equipment used to verify product conformity is calibrated against traceable standards at planned intervals, that calibration status is controlled, and that out-of-tolerance findings trigger an assessment of previously measured product. None of that is possible from a certificate that only says PASS.
Our certificates give you the underlying data — as-found condition on arrival, as-left after any adjustment, uncertainty at each point, and the standards used with their traceability. That is what makes an impact assessment defensible if an instrument comes back out of tolerance, and it is the first thing a thorough auditor asks to see.
From inspection tools to environmental chambers
Medical device manufacturing spans a wide metrology load: dimensional inspection tools on the production floor, torque tools on device assembly, balances and pipettes in the lab, and the environmental monitoring behind cleanrooms, sterilization, and controlled storage. We cover all of it across nine in-house disciplines.
For controlled storage and stability, chamber mapping is the evidence that product was held within specification everywhere it sat — not just at the controller sensor. Because moving a chamber is impractical, that work is typically performed where the chamber lives, using calibrated, traceable reference sensors.
- Dimensional inspection tools (calipers, micrometers, gauges)
- Torque screwdrivers and wrenches for device assembly
- Analytical balances and pipettes
- Data loggers and environmental monitoring instruments
- Environmental / stability chamber mapping
- Electrical test instruments
Supplier qualification, handled
We supply standard supplier-qualification packets on request — current A2LA scope of accreditation (certificate 4296.01), certificate of insurance, and quality-manual excerpts. Send your own template and we will complete it rather than making your team reformat ours.
Services medical device customers use most
Medical Device calibration FAQs
Do you provide supplier-qualification documentation?
Yes — A2LA scope of accreditation (certificate 4296.01), certificate of insurance, and quality-manual excerpts. Send your procurement template and we will fill it out and return it.
What does ISO 13485 require for calibration?
Broadly: traceable calibration at planned intervals for equipment used to verify product, controlled calibration status, records, and an assessment of prior measurements when equipment is found out of tolerance. Our ISO 13485 guide walks through it in detail.
Can you map our stability chambers on-site?
Chamber mapping is normally performed where the chamber sits, with calibrated traceable sensors distributed through the working volume. Contact us with chamber sizes and locations to discuss coverage.
Other industries we serve
Calibration built for medical device.
Send your equipment list and the compliance regimes your customers reference — we'll come back with scope confirmation, pricing, and turnaround.