The performance and safety of medical devices depend heavily on consistent accuracy, which is why the process of equipment calibration is a critical component of quality control and regulatory compliance for medical device manufacturers. Calibration is the process of configuring an instrument to provide a result within an acceptable range, ensuring the equipment's measurements are accurate and reliable. For medical devices and medical device manufacturing, this is not just a matter of efficiency but one of safety and regulatory compliance.
What is Calibration?
Over time, the precision of equipment can drift due to environmental factors, daily wear and tear, or aging. Calibration corrects this drift, ensuring the device continues to operate as expected. The calibration process compares the measurement values delivered by a device under test with the measurement values of a standard of known accuracy.
In simpler terms, it involves fine-tuning equipment so that it performs within acceptable parameters, reducing errors in measurement.
In a medical device manufacturing environment, calibration applies to various tools and instruments, including temperature controls, pressure gauges, weighing systems, and even sophisticated diagnostic machinery. And because these tools are used throughout the manufacturing process, calibration ensures that any device that takes measurements (e.g. temperature sensors, weighing systems) or uses measurement values in its process (e.g. CNC machines, 3D printers) meet both performance expectations and regulatory standards.
Why Calibration is Critical in the Medical Device Industry
The medical device industry is one of the most tightly regulated sectors. ISO standards, such as ISO 13485, emphasize the importance of ensuring that all manufacturing equipment is consistently maintained and calibrated to prevent inaccuracies. In addition, 21 CFR Part 820 - Good Manufacturing Practices, clearly states that measurement equipment shall have calibration information displayed. Not doing so could result in devices that are unsafe for patient use or ineffective in their intended function.
Here are some key reasons why calibration is crucial in this industry:
Patient Safety
Of primary importance is patient safety. Improperly calibrated equipment can lead to faulty devices, which may result in incorrect diagnoses, improper treatment, or device failure. For example, a slight deviation in a heart monitor could have life-threatening consequences.
Regulatory Compliance
Because calibration directly affects product quality and patient safety, calibration is a key requirement in ISO standards and FDA regulations. Failure to maintain proper calibration records can lead to penalties, fines, and even shutdowns of manufacturing operations.
Product Quality
In order to manufacture high quality medical devices, manufacturing processes require consistent and precise measurements. An effective calibration process ensures that medical devices are produced according to designed and intended specifications. Effective calibration reduces waste, rework, and recall risk.
Cost Savings
And by consistently meeting product quality specifications, properly calibrated equipment reduces the likelihood of errors or non-conformities, which can lead to costly production delays, material waste, or product recalls.
The Role of Regulatory Agencies
The National Institute of Standards and Technology (NIST), a US government agency, plays a key role in setting measurement standards across various industries, including manufacturing, healthcare, and information technology. NIST develops and promotes measurement standards used in calibration.
NIST’s guidelines and standards help ensure consistency, accuracy, and quality in both products and processes, making it a key player in scientific and industrial innovation. NIST’s guidelines ensure that measurements are accurate and consistent, helping manufacturers meet regulatory requirements and maintain product quality. With an industrywide standard, collaboration and compatibility between components (and suppliers) is maintained.
The Role of Calibration Labels
An important aspect of equipment calibration is labeling and status identification. When a device has been calibrated, it’s critical to mark it as calibrated or, conversely, as in need of calibration. Calibration labels effectively communicate the calibration status and other important information related to the equipment. These labels serve several important functions:
Clear Identification
Calibration labels allow workers and auditors to quickly see whether equipment is calibrated, when it was last calibrated, and when the next calibration is due. This prevents the accidental use of uncalibrated tools that could introduce errors into the manufacturing process.
In addition, many calibration labels include a field for equipment ID number, ensuring that a technician is calibrating the correct piece of equipment and is able to accurately log that information.
Audit Trail
Medical device manufacturers are often subject to internal and external audits to verify compliance with ISO standards and other regulatory requirements. Calibration labels provide a quick reference for auditors and help validate calibration traceability records, helping companies maintain compliance.
Traceability records also help in case a company needs to review the calibration history of a piece of equipment in order to determine the root cause of failure.
Consistency and Standardization
Using clearly marked calibration labels ensures that all personnel are on the same page regarding the status of equipment. This reduces the risk of human error and enhances the overall reliability of the manufacturing process.
Warning Communication
Calibration labels can communicate a warning or precaution to workers and technicians. Some devices or pieces of equipment need to be calibrated before each use. Others have voided calibration if a seal is broken. A properly designed label can effectively communicate messages to workers to follow before using a piece of equipment.
Calibration Labels from GMP Labeling
At GMP Labeling, we understand the critical role that calibration plays in the medical device industry. Our calibration labels are designed to help manufacturers meet regulatory requirements and maintain strict quality control standards. Our labels are durable, easy to apply, and customizable to suit specific requirements, ensuring they remain legible even in demanding environments.
Explore our full range of calibration labels and ensure that your equipment is always properly marked, contributing to safer, more efficient, and compliant operations.
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