For more than 20 years, MicronPA has been a partner to the medical and healthcare industries. We work with manufacturers and testing labs to ensure medical instruments are properly calibrated to the demanding specifications required by today’s professionals.

We have the years of experience and the expertise to provide the precision and accuracy you need in your devices. Our extensive experience in running calibration programs for highly regulated industries means we can help you remain in compliance with ISO standards. Our medical equipment calibration helps you provide your clients with the high-quality products they need to ensure patient health and safety.

We provide both laboratory and on-site testing as well as a range of consulting, inspection and validation services. We are accredited by the American Association for Laboratory Accreditation (A2LA) and specialize in helping our medical industry clients meet their specific regulatory and reporting requirements. For more information about our services, keep reading or contact our lab directly.

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Our Medical Device Dimensional Validation & Testing Capabilities

With over 30 years of engineering skills available to support customer requests, we offer First Article Inspection for dimensional quality during all phases of product and process requirements.

  • Applied Statistical Data Analysis for projects which warrant such procedures
  • DOE methods applied for investigative purposes as required for support
  • Statistical Monte-Carlo Simulation of limited customer variable databases
  • Qualification and validation of customer assets and equipment

  • Plastic and metal part design and fabrication
  • Life Reliability Studies for customer assets and equipment
  • Repeatability and Reliability (R&R) Studies
  • Abrasion, Torque and Force Testing

Our Process for Calibrating Medical Device Equipment

When you work with MicronPA, you can enjoy the benefits of turning to an excellent accredited calibration firm. Professional calibration of sensitive instruments is essential for sound medical processes. Your devices must be properly calibrated to meet industry regulations and requirements.

We complete these services with accuracy and reliability. Your manufacturing facility can have peace of mind knowing our processes are accredited by industry-leading organizations to assure our clients that we perform accurate, traceable work:

  • R205 Specific Requirements
  • ANSI/NCSL Z540-1-1994
  • ANSI/NCSL Z540.3-2006
  • ISO/IEC 17025:2017

In addition to performing calibration services, MicronPA is committed to proving the results of our calibrations through comprehensive certifications that are easy for our customers to access.

We prioritize a fully documented analysis of your medical device’s calibration and note what adjustments we made. We also share verification by one of our trusted, certified technicians. Our secure web certificates make data management and calibration documentation even easier for your facility. We offer both digital and hard copies so you always have access to the information you need. Our customer portal allows you to complete the following:

  • Print your calibration certificates.
  • Review instrument history.
  • Get automated email reminders for future services.
  • Generate organizational lists.

At MicronPA, we offer you excellent calibration services to keep your medical manufacturing facility operating at the highest standards.

Some Common NIST-Traceable Medical Devices We Test & Calibrate

MicronPA offers calibration services for clients across the medical industry. We are an ISO 17025-accredited calibration company and can complete instrument calibration on-site at your location or in our certified laboratories in York, PA and Virginia Beach, VA. A highly trained auditor from A2LA closely analyzes and approves our processes. We value offering greater convenience and efficiency for your organization. All of our procedures for calibration are based on ANSI, ASME, ASTM or NAVAIR procedures so you know that we offer reliable results.

MicronPA understands the medical industry needs dependable, accurate measurements to ensure the greatest quality of care. Our team tests and calibrates the following NIST-traceable medical devices:

  1. Autoclaves: Autoclave calibration involves using the most up-to-date calibration equipment and software for temperature data logging. It ensures accuracy within a very tight degree range, and you’ll have results shortly after completion of the autoclave cycle, so you’ll know whether your machine is meeting your target specifications.
  2. Moisture analyzers: We provide moisture analyzer calibration for most major instrument manufacturers. Our professional experts and superior calibration equipment mean we can provide precise, accurate calibration and quick turnaround times.
  3. Microscope calibration: Microscope calibration helps these instruments meet industry standards and regulatory requirements. It typically includes alignment, lens inspection, lens cleaning and general service and maintenance.
  4. Ovens: We can use numerous tools, including dataloggers, digital thermocouple temperature measuring systems and platinum resistance thermometers (PRTs), to help you ensure the accuracy of your laboratory incubators and ovens.
  5. pH meters: pH meter calibration uses pH solution standards at various pH levels. It ensures the accuracy of the pH meter and its probe and verifies that the two work together harmoniously.
  6. Pipettes: Pipette calibration involves working with fixed, adjustable or selectable pipettes at a range of tiny, microliter-level volumes. Our pipette calibration equipment and procedures are ISO-compliant and will stand up to the medical industry’s stringent regulatory requirements.
  7. Scales and balances: Scale and balance calibration involves cleaning and re-leveling the instrument, as well as taking before and after readings and measuring repeatability, preload linearity and corner load linearity. We recommend on-site calibration to avoid the inaccuracies that can result from jostling during shipping.
  8. Thermometer calibration: We perform thermometer and thermometer system calibration at a wide range of temperatures and with superior accuracy and precision. We can provide various services such as digital thermometer calibration, liquid-in-glass (LIG) thermometer calibration, infrared thermometer calibration, thermocouple calibration and chart recorder calibration.
  9. Vaccine cold storage: Maintaining correct temperatures for vaccine cold storage is critical for ensuring the vaccines’ efficacy. Calibration for vaccine cold storage includes meticulous attention to temperature monitoring devices, dataloggers, laboratory refrigerators and freezers. We can work with a wide range of temperatures to ensure effective vaccine storage even at the coldest temperature requirements.
  10. Viscometers: NIST-traceable viscometer calibration uses silicone standards to help your facility meet regulatory specifications and ensure high quality in its viscometer products for medical facilities.

Other NIST-Traceable Devices We Test and Calibrate

Below are several other devices for which we can provide state-of-the-art medical equipment calibration for medical device manufacturers:

  • Biological Safety Cabinet
  • Centrifuges
  • Conductivity Meter
  • Datalogger
  • Defibrillator Analyzer
  • Dialysis Reference Meter
  • Differential Pressure Gauge
  • ECG Simulator
  • EKG Electrode Impedance
  • Electrical Safety Analyzer Calibration
  • Electrosurgical Analyzer
  • Environmental Chamber & Monitoring Devices

Our Calibration Specialties

Our investment in sophisticated equipment and training for our staff allows us to provide several different medical equipment calibration and testing services.

Count on us for:

1. Mechanical Gage Calibration

We know your medical organization’s gage calibration needs are unique to your operations. Our customized services ensure you get the highest quality calibration paired with detailed certificates. The MicronPA team will measure pressure, angle, mass, volume, torque and force for the most accurate and efficient adjustments.

2. Electrical Gage Calibration

Equipped with a Wavetek 1281, an 8½ digit Selfcal multimeter and a Fluke 5520A/SC600 calibrator with a 50-turn current coil clamp meter accessory, our highly skilled technicians have the advanced tools for electronic calibrations. MicronPA performs highly precise calibrations aligned with ANSI, ASME, ASTM and more industry standards.

3. Dimensional Validation and Testing

We perform dimensional validation and testing for medical devices to support precise engineering and manufacturing. Our team can provide first-article inspections, capability studies and gage repeatability & reproducibility studies. Our capabilities include 2D and 3D, contact and non-contact dimensional inspections and scanning for product certification and verification.

Dimensional inspection is important for medical device manufacturers because it enables you to determine whether even the smallest part of the device could be causing issues with its operation. It is particularly important in first-article inspections, which allow you to find and address problems in your first production run, preventing your facility from manufacturing more flawed products. Our dimensional inspection services are ideal for castings, machined parts, prototypes, injection moldings, jigs and fixtures and 3D-printed parts, among other applications for medical devices.

4. Computed Tomography (CT) Inspection

One of our popular dimensional inspection services is CT scanning and inspection, which provides full inspection capability of the internal geometry of your devices without touching or disassembling any parts. CT scanning and inspection processes are non-destructive, comprehensive and versatile, and they make it easy to compare earlier and later versions of a component or device. We offer part-to-CAD CT scanning and inspection, part-to-part CT scanning and inspection, reverse engineering, wall thickness analysis and internal part integrity analysis to ensure regulatory compliance for your manufactured devices.

We are an A2LA-accredited facility that holds up-to-date ISO/IEC 17025:2017 and ANSI/NCSL Z540-1:1994 certifications. We perform all calibrations and inspections in accordance with ANSI, ASME, ASTM and NAVAIR protocol. Many of our staff have a background in the medical industry; as a result, we can provide dedicated service that reflects the realities of your field.

Our Medical Device Calibration Clients

Our clients include medical device manufacturers, corporate testing and development labs and other organizations. Based in York, PA, we are within a few hours’ drive of many major Mid-Atlantic cities. As a result, we can provide fast on-site service that works around your schedule. If it isn’t possible for our mobile facility to calibrate your equipment, we can arrange safe shipment to our lab and complete the work within five days.

Our clients include J & J, BD and Dentsply Sirona — a prominent manufacturer of dental equipment and related products. Whatever the specifics of your organization, we’ll help you put together a calibration schedule that keeps your sensitive gauges and other instruments working their best at all times.

Request an Estimate for Full Service Medical Calibration Services

Working with MicronPA will save you time and money while ensuring your instruments are properly calibrated and your products are compliant with the applicable standards. We are a leading medical device calibration company for Central PA manufacturers and labs throughout the Mid-Atlantic region. Count on our team for fast, professional service, excellent value and a commitment to technical excellence.

Request on-site service by contacting our lab directly. One of our representatives would be happy to answer all your questions and provide a detailed quote to meet all your medical device testing requirements. Call or email MicronPA to get started today.