Overview
What Is Medical Equipment Calibration?
Medical equipment calibration is the process of comparing a medical instrument’s measurements against a known national standard and adjusting it so its readings fall within the manufacturer’s specified tolerance. Performed under ISO/IEC 17025:2017 accreditation, it produces documented, NIST-traceable evidence that supports compliance with FDA 21 CFR Part 820, ISO 13485 quality management systems, and The Joint Commission requirements.
Medical Equipment vs. Biomedical Equipment Calibration: Is There a Difference?
Medical equipment calibration and biomedical equipment calibration describe the same accredited process applied in two different settings, and Micro Precision provides both under one ISO/IEC 17025:2017-accredited program. “Medical equipment calibration” typically refers to clinical instruments used directly in patient care, such as patient monitors, infusion pumps, and diagnostic imaging equipment. “Biomedical equipment calibration” usually refers to instrumentation used in biomedical research, university labs, and pharmaceutical development, such as centrifuges, spectrophotometers, and analytical balances. The distinction is about where the equipment is used, not the standard it is held to.
Types of Medical & Biomedical Equipment We Calibrate
- Patient monitors and vital sign monitors
- Infusion pumps and syringe drivers
- Anesthesia machines and gas analyzers
- Electrocardiograph (ECG/EKG) machines
- Defibrillators and automated external defibrillators (AEDs)
- Diagnostic imaging equipment (X-ray, ultrasound dosimetry)
- Clinical and research laboratory analyzers and centrifuges
- Incubators, ovens, and temperature-controlled storage
- Spectrophotometers and colorimeters
- Surgical power tools and electrosurgical units
- Pipettes, analytical balances, and volumetric glassware
- Pressure gauges and transducers used in clinical settings
The Micro Precision Advantage
Healthcare and biomedical organizations choose Micro Precision because our calibration programs are built around the operational realities of clinical and research environments, backed by accreditation, traceability, and more than 50 years of calibration experience:
Biomedical Equipment Calibration for Research & Development
Biomedical research drives the next generation of lifesaving treatments, and the validity of that research depends entirely on precise, reliable instrumentation. Whether you are conducting research in a university laboratory, developing therapeutics at a pharmaceutical company, or validating the performance of new medical devices, Micro Precision delivers accredited calibration with NIST-traceable documentation your team and your auditors can rely on.
Precision You Can Trust
- Reproducibility — accredited reference standards and controlled procedures support reproducible, defensible research results.
- Protocol Continuity — scheduling that works around your research timeline, in-lab or on-site.
- Efficiency — in-laboratory and on-site solutions minimize disruption to your schedule.
- Compliance — full traceability records consistent with FDA, ISO 13485, and ISO/IEC 17025 expectations.
Medical & Biomedical Calibration Service Levels
Micro Precision offers three calibration service levels for medical and biomedical equipment, from basic traceable calibration to fully accredited ISO/IEC 17025:2017 and ANSI/NCSL Z540.3 documentation, so you can match the level of documentation to your compliance requirement.
| Type of Service | Traceable | Traceable with Data | Accredited (ISO:IEC 17025:2017, Z540.3) |
|---|---|---|---|
| Calibrated to manufacturers specifications traceable to SI Units | |||
| ISO 9000 Compliant | |||
| Calibration certificates, data, maintained on secure web based tool (CDM) | |||
| Detailed calibration certificates and calibration stickers | |||
| Instrument adjustment (if found out of tolerance) | |||
| ANSI/NCSL Z540-1 compliant | |||
| Calibration Data | |||
| Logo from Accreditation body, Expanded Measurement Uncertainty | |||
| ANSI/NCSL Z540.3 compliant |
FAQs
Medical equipment calibration is the process of verifying and adjusting a medical instrument’s measurements against a traceable national standard to ensure accuracy within the manufacturer’s specified tolerance. It is required by FDA 21 CFR Part 820, ISO 13485, and The Joint Commission to ensure that clinical measurements are reliable, patient safety is maintained, and quality management documentation meets regulatory audit requirements.
Medical equipment calibration and biomedical equipment calibration are the same accredited process applied to different settings. Medical equipment calibration generally covers clinical instruments used in direct patient care, such as patient monitors and infusion pumps. Biomedical equipment calibration generally covers instruments used in biomedical research and laboratory settings, such as centrifuges and analytical balances. Micro Precision provides both under one ISO/IEC 17025:2017-accredited program.
We calibrate instruments for organizations including, but not limited to: Healthcare Providers, Biotech Research and Development Companies, Pharmaceutical Businesses, Academic Research Institutions, Healthcare Facilities, Medical Equipment Service Providers, and hospital systems nationwide.
We calibrate a variety of medical and biomedical instruments including: patient monitors, vital sign monitors, infusion pumps, anesthesia machines, ECG/EKG machines, defibrillators, diagnostic imaging equipment, clinical laboratory analyzers, centrifuges, incubators, spectrophotometers, surgical power tools, electrosurgical units, pipettes, and pressure gauges used in healthcare and research settings.
Micro Precision offers three medical and biomedical calibration service levels: Traceable, Traceable with Data, and Fully Accredited (ISO/IEC 17025:2017 and ANSI/NCSL Z540.3). See the “Medical & Biomedical Calibration Service Levels” section above for a full comparison of what each level includes.
Calibration frequency for medical equipment is determined by the manufacturer’s recommended calibration interval, your organization’s quality management system requirements, regulatory guidelines (FDA 21 CFR Part 820, ISO 13485), and the instrument’s historical performance data. High-use or high-risk instruments may require more frequent calibration intervals than lower-risk equipment. Micro Precision’s CDM software automatically tracks calibration due dates for your entire instrument inventory.
Yes. Micro Precision offers both on-site and in-laboratory medical equipment calibration services. Our field technicians travel to your facility to calibrate instruments in place, minimizing clinical downtime. For instruments that can be safely transported, our accredited in-laboratory calibration service provides the highest level of accuracy and documentation.
Yes. Micro Precision is accredited under ISO/IEC 17025:2017 and compliant with ANSI/NCSL Z540.3. All calibrations are NIST-traceable, supporting FDA 21 CFR Part 820 and ISO 13485 quality system requirements.
Medical & Biomedical Equipment Calibration Services
Micro Precision delivers ISO/IEC 17025:2017-accredited, NIST-traceable calibration for medical and biomedical equipment nationwide, with in-lab and on-site options.
Industries We Serve
Micro Precision is an industry-driven calibration service provider that has been trusted and partnered with businesses and organizations for more than 50 years.
Our Services
Elevate your projects to the next level with our bespoke calibration solutions for medical and biomedical equipment.
Calibration
Micro Precision is a global leader in equipment calibration. We service a wide range of applications and industries, and we offer on-site and laboratory calibration services.
Global Solutions
Our global support team offers a range of additional services that enhances your experience. This includes technical support, asset management and more.
CDM Software
Managing your equipment calibration status is made easy with our customer data management software.
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Service Area
If you have any inquiries, recommendations, or simply wish to connect with us, we’d love to hear from you! Please don’t hesitate to reach out to us at
22835 Industrial Place Grass Valley CA 95949
or you can contact us via phone at
(530) 268-1860
or email us at contact@microprecision.com
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