C
CalibrationOS
Sign InGet Started
← All Industries

Calibration Management for Medical Devices

ISO 13485FDA 21 CFR Part 82021 CFR Part 11

Medical device manufacturers operate under intense regulatory scrutiny where calibration failures can directly impact patient safety and trigger FDA enforcement actions. Calibration records must be maintained for the lifetime of the device — often 10 to 30 years for implantable products — and calibration software itself must be validated per 21 CFR Part 11 and GAMP 5 guidelines.

Calibration Challenges in Medical Devices

  • Maintaining calibration records for the lifetime of medical devices, which can span decades for implantable products
  • Validating calibration management software per 21 CFR Part 11 and GAMP 5 with IQ/OQ/PQ protocols
  • Performing rapid out-of-tolerance impact assessments that link to device serial numbers and distribution records for potential field actions
  • Managing calibration across cleanroom and controlled environments with restricted instrument movement protocols
  • Satisfying both FDA and EU MDR/IVDR calibration documentation requirements for dual-market products

How CalibrationOS Solves These Challenges

Lifetime Record Retention

CalibrationOS implements configurable retention policies that preserve calibration records for the required device lifetime, with tamper-evident storage and guaranteed retrieval for regulatory inspections years after device production.

21 CFR Part 11 Compliance

Built-in audit trails, electronic signatures with meaning capture, role-based access controls, and validation-ready architecture satisfy FDA electronic records requirements without additional third-party tools.

Device Lot Traceability

Out-of-tolerance impact assessments automatically link affected calibration events to device serial numbers, lot numbers, and distribution records, supporting field safety corrective action decisions.

Validation Documentation Package

CalibrationOS provides IQ/OQ/PQ protocols, requirements traceability matrix, risk assessment, and pre-written test scripts following GAMP 5 guidelines to streamline customer-side validation efforts.

FAQ

How long does CalibrationOS retain medical device calibration records?

CalibrationOS supports configurable retention periods aligned with device lifetime requirements. For implantable devices, records can be retained for 30+ years with guaranteed integrity and retrievability. Retention policies can be set per device family or regulatory market.

Does CalibrationOS come with FDA validation documentation?

Yes, CalibrationOS includes a comprehensive validation package with IQ/OQ/PQ protocols, requirements traceability matrix, risk assessment per GAMP 5, and pre-written test scripts. This package typically reduces customer validation effort by 60-70% compared to validating from scratch.

Can CalibrationOS link out-of-tolerance instruments to affected medical devices?

Yes, when an instrument fails calibration, CalibrationOS identifies all devices inspected or tested with that instrument since its last passing calibration. The platform generates impact assessment reports with device serial numbers, lot numbers, and distribution data to support CAPA and potential field action decisions.

How does CalibrationOS support EU MDR compliance for calibration?

CalibrationOS addresses EU MDR Annex I requirements for measurement traceability and equipment qualification. The platform supports dual-market documentation, generating calibration records that satisfy both FDA 21 CFR Part 820 and EU MDR technical documentation requirements simultaneously.

Ready for Medical Devices Calibration Compliance?

Start free with CalibrationOS — no credit card required.

Get Started Free