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Calibration Requirements and Equipment Controls for
Medical Devices

Avoid common pitfalls related to calibration requirements and equipment controls.

Both the FDA and ISO 13485 require medical device manufacturers to calibrate equipment. Medical device manufacturing depends on accurate testing and inspection results, from the initial design and development of a device to the shipment of a safe, effective product. Companies must also test the materials they use to manufacture a device to ensure that they are appropriate for the specific product.

In addition, companies must perform other manufacturing activities to a high degree of reliability, including design and process validation activities, assessment of material biocompatibility, packaging studies, sterilization validation, and electrical performance testing.

Properly calibrated measuring and monitoring equipment is required to perform all of these tests accurately. For this reason, haphazard or inconsistent calibration activities are a red flag to regulatory bodies.

This practical course will show you how to interpret and apply the calibration requirements and equipment controls for medical device manufacturers, and it will help you understand what compliance means for your organization. You will learn how to avoid common issues related to calibration and equipment controls, so your organization can rely on accurate test results.

Upcoming Dates and Locations

Please Contact Us if you need additional information or if you don't see a date that works for you. To register by phone, call 1.888.532.6360  |  On-Site training available, learn more »

 
There are currently no public dates scheduled. All our courses are available to be held at a location of your choice. Please contact us for more information.

Objectives

At the end of this course, participants will be able to:

  • Understand the applicable calibration standards for medical devices, including FDA’s Quality System Regulation (QSR), ISO 13485, ISO 9001, and ISO 17025.
  • Identify and interpret the relationship and differences between the applicable calibration standards and guidance.
  • Interpret and apply the technical requirements to your organization.
  • Understand the importance of an effective calibration program and industry best practices for medical device manufacturers.

Topics

  • Overview of standards
    • FDA’s QSR
    • ISO 13485
    • ISO 17025
    • ISO 9001
  • Importance of an effective calibration program
  • Warning letter/483 issues related to calibration program deficiencies
  • Terminology
  • Calibration requirements
  • Inspection, measuring, and test equipment controls
  • Protection and maintenance of measuring equipment and instruments
  • Equipment controls
  • Integration of measurements into the quality system
  • Audit of the calibration program and audit readiness

Who Should Attend

This course is aimed at members of your organization who need an in-depth understanding of calibration requirements and equipment controls for medical devices, including quality assurance, quality control, quality engineering, QMS auditors, manufacturing engineering, production engineering, research and development engineering, calibration, and technical support professionals.

Number of Days: 2
CEUs: 1.5
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Bring any of our classes to your location - Oriel STAT A MATRIX on-site training is the perfect solution for training groups of five or more employees or launching a companywide training effort. It's cost-effective, completely customizable, and absolutely hassle-free. For more information, call 1.888.532.6360 or Contact Us.

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