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We create quality excellence in healthcare on every continent.

We are quality makers – a team of experienced experts in healthcare and health-tech quality. Our quality services for the healthcare and medical technology industries cover external quality assessments, regulatory consulting, clinical research, audits and certifications, and training. Our expertise and knowledge benefit customers from medical device and in vitro diagnostic manufacturers to startups as well as healthcare units to clinical laboratories.

Are you familiar with our training selection?

We offer an even wider range of training services on quality management, patient safety and medical device regulation. Whether you're a quality expert, laboratory professional, development manager or radiology professional, we have the training that's right for you.

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Clinically Relevant External Quality Assessment EQAS

All medical laboratories and point-of-care testing sites are recommended to verify their measurement quality through external quality assessment. Furthermore, external quality assessment is a basic requirement in all quality systems associated with laboratory operations. Labquality's EQA schemes fully comply with ISO/EN 15189 requirements.

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QA/RA Services for Medical Device Manufacturers

Labquality’s experts provide assistance in building and managing quality management systems.

Latest news

03/27/2023

Labquality to expand clinical trial services to pharmaceuticals and biotech

Labquality corporation acquires Clinical Consulting corporation, a Polish company that specializes in clinical trial services for pharmaceuticals, biotech, and medical device companies.
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03/15/2023

Registration for new pilot rounds now open

Register now for our planned pilot rounds free of charge.
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03/13/2023

Welcome to our new website!

Our new and modern website offers a user-friendly experience for our customers.
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03/03/2023

Extension of the MDR transition period – do not stop working towards the certification!

The European Parliament recently approved the extension of the MDR transition period. What does this mean for medical device manufacturers?
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03/02/2023

Data management in clinical investigations – Part 3: Data traceability

Data traceability is a foundational principle for clinical investigations aiming to demonstrate the performance and safety of medical devices.
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