Delivering Excellence in Male Fertility Testing and DNA Fragmentation Analysis

ExamenLab is dedicated to providing male fertility tests with the utmost accuracy and reliability, backed by an accreditation and certification program that underscores our commitment to patient care and diagnostic excellence.

At ExamenLab, our commitment to quality is central to everything we do. Our quality framework ensures that all of our products and services meet the highest international standards, providing confidence to both healthcare professionals and patients. With a strong focus on precision, reliability, and regulatory compliance, ExamenLab upholds a robust system of quality management across all areas of operation.

ISO Certifications

ISO 13485:  Certified for the Design and Development of DNA Fragmentation Tests for Male Fertility

ExamenLab is proud to hold ISO 13485 certification, an internationally recognised standard for quality management systems in the medical device industry, for the design, development and manufacture of in vitro diagnostic (IVD) DNA-based assays for sperm cell analysis (specifically the Exact® and Extend® tests). Key features of ISO 13485 compliance include: –

• Rigorous quality management practices
• Risk management throughout the product lifecycle
• Control over product design, development, and production
• Continuous improvement of product quality and safety

This certification ensures best practice through the entirety of the IVD test’s life cycle, from initial design to the results patients receive.

Access our BSI ISO 13485 certificate here (MD 723205) and please see ExamenLab Ltd testing table below for insight into which tests are covered under this accreditation.

ISO 15189: Accredited for the Delivery of Male Fertility Testing Services

In addition to our ISO 13485 certification, ExamenLab holds ISO 15189 accreditation, which specifically applies to the delivery of some of our medical laboratory services. ISO 15189 accreditation is an internationally recognised standard that verifies the competence, integrity and impartiality of our laboratory and underpins confidence in the quality of the services we supply. Key features of ISO 15189 accreditation include:

• Assurance of the technical competence of our laboratory staff
• Reliable and accurate test results
• Stringent quality control measures throughout the testing process
• External peer-to-peer comparison to assess accuracy and reliability of test results

Details of the current ISO 15189 accreditation status for each of our testing services is supplied below. ExamenLab is working towards full accreditation for its portfolio of medical tests offered.

Access our UKAS ISO 15189 accreditation here (25925) and please see ExamenLab Ltd testing table below for insight into which tests are covered under this accreditation.