For medical device manufacturers
Calibration software for medical device manufacturing under ISO 13485 and FDA 21 CFR 820
In medical device manufacturing, a single measurement can decide whether a product is safe to ship, so your calibration records have to satisfy a notified body and an FDA investigator alike. ISO 13485 clause 7.6 and FDA's Quality Management System Regulation (QMSR) under 21 CFR 820 both require you to control measuring equipment, keep it traceable, and prove that a drifted instrument did not send suspect product into the field. Axiospec gives device manufacturers documented, attributable calibration records, a tamper-evident audit ledger, and reverse traceability from any instrument to the measurements and product it touched, so those records exist by default instead of getting rebuilt the week before an audit.
Calibration challenges in Medical Device Manufacturing
Electronic record integrity under 21 CFR Part 11
Your calibration records are quality records, and more of them are electronic every year. FDA 21 CFR Part 11 expects electronic records and signatures to be attributable, time-stamped, and protected from undetected change. A calibration log kept in a shared spreadsheet cannot show who signed a result, or prove a value was never altered after the fact.
Proving prior product was not affected
When a gage is found out of tolerance, ISO 13485 clause 7.6 and FDA 21 CFR 820 both require you to assess the validity of earlier measurements and act on any affected product. Reconstructing which lots a drifted instrument touched from paper and disconnected files is slow, and it is the first thing an investigator asks to see.
Ready for a notified body or FDA inspection at any time
An audit or an unannounced FDA inspection can arrive with little notice, and device makers often carry ISO 13485, the FDA Quality Management System Regulation (QMSR), and ISO 9001 at once. Pulling complete, current calibration status and certificates for hundreds of instruments on demand is hard when the data lives in more than one place.
Defensible intervals and acceptance decisions
Accepting or rejecting product against a tolerance depends on the uncertainty and test uncertainty ratio of the gage doing the measuring. Many device shops still set calibration intervals and acceptance limits by habit rather than from the instrument's own reliability and uncertainty data.
How Axiospec helps Medical Device Manufacturing teams
A tamper-evident record for every calibration
Every calibration is written to a hash-chained audit ledger with bound e-signatures and optional two-person maker and checker sign-off. Records are attributable and time-stamped by default, which supports the record integrity that 21 CFR Part 11 and medical-device quality systems expect.
Reverse traceability when an instrument drifts
When a gage is found out of tolerance, reverse-trace from that instrument to the measurements and product it touched. You can assess and document the validity of prior results in minutes instead of rebuilding it from paper, exactly what ISO 13485 clause 7.6 and FDA 21 CFR 820 ask for.
As-found and as-left readings, signed and certified
Log as-found and as-left readings and Axiospec posts an automatic pass or fail against tolerance. Each event produces a PDF certificate and records the reference standard behind it, evidencing traceability to national or international measurement standards.
Inspection-ready at a glance
A Due Calendar shows what is due, due soon, and overdue, and an Audit-Readiness Scorecard tracks a live 0 to 100 score across your equipment file. When an assessor arrives, current status and certificates for every instrument are one search away.
Metrology behind your measurement decisions
Per-instrument Metrology Insights give you a reliability-based interval, a test uncertainty ratio, and conformance and false-accept risk. Uncertainty budgets and AIAG Gage R&R sit alongside the calibration record, so intervals and acceptance limits come from data, not habit.
Multi-site rollup, easy migration, and mobile logging
Roll up multiple plants and contract manufacturers into one view, and import your current gages from CSV, Excel, GAGEpack, or GAGEtrak, with free white-glove migration if you would rather hand it over. Log calibrations from the floor with the native iOS and Android apps, QR-code scanning, and voice logging.
See Axiospec on real calibration data
Open a working calibration record and click through it. No signup, no credit card.
Medical Device Manufacturing calibration software: common questions
Does FDA 21 CFR 820 require calibration software?
No. FDA 21 CFR 820 requires you to control, calibrate, and keep records for inspection, measuring, and test equipment, and 21 CFR Part 11 governs electronic records and signatures, but neither names a specific tool. As of 2026 the FDA's Quality Management System Regulation aligns 21 CFR 820 closely with ISO 13485 on equipment control. Software is how most manufacturers keep those records attributable and recoverable. Axiospec provides that system; conformance is determined by FDA and your notified body or registrar.
Is Axiospec 21 CFR Part 11 compliant?
Part 11 compliance is a determination made about your whole validated system and how you use it, not a badge a vendor hands over. Axiospec provides features that support Part 11 record integrity: e-signatures bound to each calibration, a tamper-evident hash-chained ledger, and time-stamped attribution on every entry. Whether your implementation meets Part 11 is decided by you and FDA, including your own validation.
Can Axiospec import our existing medical device gage records?
Yes. You can self-serve import from CSV, Excel, GAGEpack, or GAGEtrak, and the team offers free white-glove migration if you would rather hand it over. Your calibration history comes in as real ledger entries, so traceability and attribution are preserved from the start rather than rebuilt by hand. You can try the whole flow in the live demo with no signup and no credit card before you move any data.
Is Axiospec a good fit for a small medical device manufacturer?
Yes. The free plan is the full platform capped at 50 active assets with unlimited users and no per-seat charge, which fits many small device shops and startups without a paid tier. You get the tamper-evident ledger, PDF certificates, reference-standard traceability, and the Due Calendar from day one, and you can move to a paid plan from $59 per month when you need more assets, or Professional and above for the REST API. Axiospec produces clean, traceable, audit-ready records; it does not certify compliance, which FDA and your notified body or registrar determine.
Axiospec is a documentation and workflow tool. It helps Medical Device Manufacturing teams produce clean, traceable, audit-ready calibration records; certification and conformance depend on your own processes, scope, and assessor.
Audit-ready from day one
Unlimited users, self-serve import in an afternoon, and a tamper-evident record for every instrument.
Free plan, no credit card · Unlimited users · Nothing to install