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 a drifted reference standard to every calibration it stood behind, so those records exist by default instead of getting rebuilt the week before an audit.
Calibration challenges in Medical Device Manufacturing
Electronic record integrity
Your calibration records are quality records, and more of them are electronic every year. ISO 13485 clause 4.2.5 expects records to stay legible and retrievable, with every change identifiable. 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, attributed and time-stamped. You can require an e-signature on each calibration and turn on two-person maker and checker approval. Both are off until you switch them on.
Reverse traceability when an instrument drifts
When a reference standard is found out of tolerance, list every recorded calibration that used it. That list is the starting point for your clause 7.6 assessment of prior results and any affected product. Which lots each calibration touched stays in your own production records.
As-found and as-left readings, signed and certified
Log as-found and as-left readings and Axiospec posts an automatic out-of-tolerance check 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 across your equipment file, with reminders so nothing goes overdue quietly. 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.
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?
No. Axiospec does not offer a 21 CFR Part 11 validation package, and we do not claim Part 11 compliance. Whether your records meet Part 11 is decided by you and FDA. If Part 11 applies to your calibration records, read our software validation summary first. It lists what the product does and the gaps.
-
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 instruments 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 instruments, 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
Each instrument gets a tamper-evident calibration record.
Got a gage list? Send it over and we load it for you, usually in a couple of business days. Free on every plan.
Free plan, no credit card · Unlimited users · Nothing to install