Calibration for medical device manufacturers - a complete guide

Calibration for medical device manufacturers ensures that monitoring, measuring and test equipment produces reliable results when verifying product quality, performance and safety. Under ISO 13485:2016, manufacturers must control relevant monitoring and measuring equipment, including calibrating or verifying it where necessary to ensure valid results. A robust calibration programme therefore helps manufacturers maintain measurement accuracy, demonstrate regulatory compliance and provide confidence that decisions about medical device conformity are based on reliable data.

From electrical test equipment to pressure gauges, temperature sensors and dimensional measuring tools, medical device manufacturing can depend on numerous measurements. Understanding how these instruments should be calibrated, documented and managed is therefore an important part of an effective medical device quality management system (QMS).

Why is calibration particularly important in medical device manufacturing?

Calibration gives medical device manufacturers confidence that the measurements used to determine product conformity are accurate and reliable. An inaccurate instrument can introduce uncertainty into inspection, testing and manufacturing processes, potentially affecting product quality and safety.

ISO describes ISO 13485 as the internationally recognised quality management system standard for the design and manufacture of medical devices. It is specifically intended to help organisations consistently meet customer and regulatory requirements for medical device safety and effectiveness.

Calibration forms part of this wider quality framework by providing confidence in the measurements upon which quality decisions depend.

What are the main medical device calibration requirements?

ISO 13485:2016 is one of the principal standards affecting the control of measuring equipment within medical device manufacturing.

Clause 7.6 addresses the control of monitoring and measuring equipment. Where equipment is necessary to provide evidence that products meet specified requirements, manufacturers need appropriate processes to ensure monitoring and measurement can be carried out consistently with those requirements.

Where necessary to ensure valid results, this includes calibration, verification or both at specified intervals or before use. Manufacturers also need appropriate records and controls for equipment that is found not to conform to requirements.

Importantly, calibration is therefore not simply about obtaining a certificate once a year. Manufacturers need a controlled system for managing their equipment and the resulting measurement information.

What equipment needs to be calibrated?

Any monitoring or measuring equipment whose accuracy is necessary to demonstrate that specified product requirements have been met may require appropriate calibration or verification controls. Rather than assuming every instrument needs the same treatment, manufacturers should establish which measurements influence product conformity and determine suitable controls and calibration intervals accordingly. The exact equipment will depend on the device and manufacturing process, but common examples can include:

What does IEC 62353 mean for medical electrical equipment?

IEC 62353 covers recurrent testing and testing after repair of medical electrical equipment and systems, including safety assessments during servicing, maintenance and inspection.

For organisations carrying out these activities, the reliability of the test equipment used to make electrical safety measurements is consequently important.

IEC 62353 should not, however, be treated as a general calibration standard for test instruments. Instead, manufacturers should consider calibration of electrical safety analysers and other measuring equipment as part of their wider system for ensuring dependable measurement results.

Why is measurement traceability important?

Metrological traceability creates a documented link between a measurement result and recognised reference standards through an unbroken chain of calibrations.

For medical device manufacturers, traceability helps make measurement results defensible. Instead of simply stating that an instrument is accurate, appropriate calibration records provide evidence of how its measurements relate back to recognised standards.

This becomes particularly valuable during audits, investigations and product quality decisions where manufacturers may need to demonstrate why a measurement result can be trusted.

Why use a UKAS-accredited calibration laboratory?

Using a UKAS-accredited calibration laboratory provides independent assurance of the laboratory's competence for the specific calibration activities included within its accredited scope.

UKAS accredits calibration laboratories against ISO/IEC 17025:2017, the international standard covering the competence, impartiality and consistent operation of testing and calibration laboratories. UKAS also highlights measurement traceability to national standards, appropriate equipment, trained personnel and accurate reporting among the factors underpinning laboratory competence.

However, ISO/IEC 17025 accreditation and ISO 13485 compliance are not interchangeable. ISO 13485 concerns the medical device organisation's QMS, while ISO/IEC 17025 concerns laboratory competence. Manufacturers should also confirm that the particular calibration they require falls within the provider's accredited scope.

Improve your calibration programme with DM

An effective medical device calibration programme should identify critical measuring equipment, define appropriate calibration controls and maintain records that allow measurement traceability and equipment status to be demonstrated.

Quality Managers should regularly review their equipment register, calibration intervals, certificates and procedures for handling out-of-tolerance results. Doing so turns calibration from a periodic administrative task into an integral part of quality assurance.

At DM Calibration, our UKAS-accredited calibration services support organisations requiring reliable, traceable measurements across a wide range of electrical and mechanical parameters. By combining specialist laboratory capabilities with on-site calibration services, we can help medical device manufacturers reduce equipment downtime while maintaining the measurement controls their quality processes demand. Download our guide below to find out more.