We Are Quality Makers

We break quality barriers for you.

External Quality Assessment Services

Our clinically relevant EQA programs and quality controls are recognized internationally.

Quality Excellence in MedTech

Our team of experts provides MedTech organizations with high-quality services related to medical device regulations, quality management, and market authorizations.

Labquality Days 2024

The scientific program has been published and registration is now open!

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, pharmaceutical and medical technology industries cover external quality assessments, regulatory consulting, clinical investigations and trials, audits and certifications, and training. Our expertise and knowledge benefit medical device and in vitro diagnostic manufacturers, pharmaceutical companies, healthcare units, and 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.

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.

Who needs EQAS?

QA/RA Services for Medical Device Manufacturers

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

Latest news

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News

20/09/23 12:09

Meet us at BCLF 2023

Labquality’s international sales team will be available for meetings at the XXX Meeting of the Balkan Clinical Laboratory Federation on 27-30 September 2023 in Montenegro.

Data management in clinical investigations - Part 4: Statistical considerations for pivotal investigations

Article

06/09/23 09:00

Data management in clinical investigations - Part 4: Statistical considerations for pivotal investigations

Medical device manufacturers planning their first pivotal premarket investigations for CE-marking benefit greatly from early collaboration with statistics professionals and an understanding of statistical principles. We offer data management, biostatistics and data protection services as part of the wider CRO clinical investigations offering.