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Labquality

About us

Welcome to Labquality – the house of quality.

We are quality makers – a team of experienced experts in healthcare and health tech quality. 

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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 start-ups as well as healthcare units to clinical laboratories.

Currently, we serve customers all over the globe in over 60 countries. Our team consists of 80 skilled professionals, and our offices are in Finland (Helsinki, Tampere, and Oulu) and Germany (Kassel). Our company is part of COR Group.

It's all about quality!

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EXTERNAL QUALITY ASSESSMENT SERVICES (EQAS)

We offer clinically relevant external quality assessment schemes (EQAS) for medical laboratories and point-of-care testing sites to monitor and improve their performance and quality. Our external quality assessment (EQA) service program includes approximately 250 products, covering all specialties of laboratory medicine.

MEDICAL DEVICE CONSULTING SERVICES

We offer global regulatory and quality services for medical devices and in vitro diagnostics. Our team of experts serves medical device and IVD manufacturers by providing comprehensive regulatory consulting and quality affairs services for compliance with any national regulations.

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CRO SERVICES

Labquality provides a comprehensive offering and expertise for the clinical investigations of medical devices. We offer extensive clinical investigations support for the entire life cycle of a product from the early stages of product development to post-market surveillance. Our clinical investigations services are conducted according to the ISO 14155:2020 standard, EU MDR, and national requirements.

TRAINING SERVICES

We offer professional training services on quality management, laboratory medicine and regulatory affairs including seminars, online courses, and tailored training programs.

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We create quality excellence in healthcare on every continent. 

That's our vision.

We are Quality Makers.
We break quality barriers for you. 

That’s how we see our mission. 

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LABQUALITY'S CERTIFICATIONS AND ACCREDITATIONS

  • ISO 9001 certified management system
  • ISO 17043 for quality assessment schemes
  • FINAS, S023, SFS-EN ISO/IEC 17021-1:2015 certification body

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