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We believe that education and support across the IVD industry can only improve the success of patients having access to life changing diagnostic devices. Our team of Quality and Regulatory IVD experts have extensive experience within their respective fields.

Key Terms in Diagnostics

In Vitro Diagnostic (IVD) Devices
Devices or reagents used for testing specimens from the human body outside the body to diagnose or monitor health conditions.

CE Marking
A certification indicating compliance with European Union (EU) regulations for IVD devices and other products.

Regulatory Affairs
The field focused on ensuring diagnostic products meet regulatory requirements set by authorities such as the FDA, EMA, or local agencies.

Clinical Performance
A measurement of how effectively a diagnostic test or device performs in clinical settings.

Sensitivity
The ability of a diagnostic test to correctly identify those with the disease (true positive rate).

Specificity
The ability of a diagnostic test to correctly identify those without the disease (true negative rate).

Accuracy
The degree to which the result of a diagnostic test agrees with the true value or gold standard.

Precision
The consistency or repeatability of a diagnostic test’s results when performed under similar conditions.

Biomarkers
Biological molecules or indicators used in diagnostics to assess health conditions or diseases.

LDT (Laboratory Developed Test)
A type of IVD that is developed, validated, and used within a specific laboratory.

Risk Management
The process of identifying, evaluating, and mitigating risks related to diagnostic devices, ensuring patient safety.

Traceability
The ability to trace the origins, history, and status of a diagnostic product, ensuring product quality and safety.

Post-Market Surveillance (PMS)
Ongoing monitoring of diagnostic devices after they are marketed, to ensure continued safety and performance.

Clinical Evaluation
A systematic process of evaluating clinical data to confirm the performance and safety of a diagnostic device.

ISO 15189
A standard for medical laboratories, detailing requirements for quality and competence in diagnostic testing.

Harmonised Standards
Standards adopted by multiple countries or regions, making it easier to market IVD devices internationally.

Companion Diagnostic
A diagnostic test that is used alongside a specific therapy to help determine the most appropriate treatment for patients.

Regulatory Submission
The process of submitting data and documentation to regulatory authorities to get approval for a diagnostic device.

FDA 510(k) Clearance
A premarket submission to the FDA demonstrating that an IVD device is substantially equivalent to one already on the market.

Clinical Trial
Research studies conducted to evaluate the safety and effectiveness of diagnostic devices in humans.

ISO Standards Relevant to Diagnostics

ISO 13485:2016 – Quality Management Systems for Medical Devices
This standard specifies requirements for a quality management system (QMS) for the design and manufacture of IVD devices.

ISO 15189:2012 – Medical Laboratories – Requirements for Quality and Competence
Specifies requirements for the competence and quality management of medical laboratories, including those providing diagnostic testing services.

ISO 14971:2019 – Risk Management for Medical Devices
Describes the process for managing risks associated with IVD devices, helping ensure patient safety and device performance.

ISO 17511:2003 – In Vitro Diagnostic Medical Devices – Measurement of Quantities in Biological Samples
Provides guidelines for measuring quantities in biological samples, which is essential for diagnostic test systems.

ISO 11607:2006 – Packaging for Terminally Sterilized Medical Devices
Defines the packaging requirements for IVD devices that need to be sterilized, ensuring they remain sterile and safe until use.

ISO 15197:2013 – In Vitro Diagnostic Test Systems – Requirements for Blood Glucose Monitoring Systems
Specifies performance requirements for blood glucose monitoring devices, focusing on accuracy and reliability.

ISO 62366:2015 – Usability Engineering for Medical Devices
Provides guidelines for ensuring that diagnostic devices are safe and effective for use by healthcare professionals and patients.

ISO 20417:2021 – Information Supplied by the Manufacturer
Establishes requirements for labelling and providing information about IVD devices to ensure proper use and compliance with regulations.

ISO 10993-1:2018 – Biological Evaluation of Medical Devices
Defines the requirements for evaluating the biocompatibility of materials used in IVD devices, ensuring they do not cause harm to patients.

ISO 14001:2015 – Environmental Management Systems
Specifies requirements for managing the environmental impact of diagnostic device manufacturing processes.

ISO 13488:1996 – General Requirements for Laboratory Performance of Diagnostic Systems
Specifies the requirements for laboratory use and performance of diagnostic systems, ensuring consistent and accurate results.

ISO 18113-1:2009 – In Vitro Diagnostic Medical Devices – Information Supplied by the Manufacturer – Part 1: Labels
Covers the labelling requirements for IVD devices, ensuring that key information is communicated to end-users.

ISO 23907:2019 – Medical Devices – Packaging for Terminally Sterilised Medical Devices
Provides requirements for packaging IVD devices, ensuring they remain sterile and safe throughout their lifecycle.

ISO 9001:2015 – Quality Management Systems
A general standard for quality management, applicable to organisations manufacturing diagnostic products.

ISO 17025:2017 – General Requirements for the Competence of Testing and Calibration Laboratories
Specifies the requirements for the competence of laboratories involved in testing diagnostic devices or conducting clinical diagnostic testing.

ISO 17043:2010 – Conformity Assessment – General Requirements for Proficiency Testing
Specifies the requirements for proficiency testing in diagnostic laboratories, ensuring the accuracy and reliability of test results.

ISO 22674:2003 – In Vitro Diagnostic Devices – Requirements for Immunoassay Systems
Specifies the performance requirements for immunoassay-based diagnostic systems.

ISO 18113-2:2011 – In Vitro Diagnostic Devices – Information Supplied by the Manufacturer – Part 2: Instructions for Use
Provides guidelines for creating instructions for use that accompany IVD devices, ensuring that end-users understand how to operate the devices properly.

ISO 15190:2003 – Laboratory Medicine – Requirements for Safety
Details safety requirements for laboratory environments where diagnostic testing takes place, ensuring safe practices for handling IVDs.

ISO 11737:2018 – Sterilisation of Medical Devices – Microbiological Methods
Specifies microbiological methods for sterilising IVD devices, ensuring that all microbial life is eradicated to prevent infection.