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Commitment to quality - Certificates

The excellence at the service of diagnostic

We are committed to provide high quality medical diagnostic tests and ultimate services to customers worldwide. We will go further than our competitors to make the difference. 

Our ambition is to provide first-in-class diagnostic products for patient health assessment. The values and processes of our organization are fully tuned to optimize products quality. Furthermore, our commercial, technical and scientific teams are attentive to implicit and explicit needs of our current and future customers. We want to excel on customer orientation, flexibility and services.

We have a solid experience for more than 30 years in the development and manufacturing of clinical in-vitro diagnostic products and use the same rigorous and reliable processes for manufacturing and quality control of research products.

On the road to excellence, we do not just guard and assure quality of our products and services, but we promote Continuous Improvement at all levels of the company. As part of that, we also evaluate, challenge and follow up on the quality of the products and services of our suppliers.

In order to design, manufacture and provide compliant, effective and safe products for diagnostic markets worldwide,

we maintain a Quality Management System fully in accordance with the following requirements:

  • ISO 9001:2015;
  • ISO 13485:2016;
  • IVD Directive 98/79 EC (European Union);
  • SOR/98-282 (Canada);
  • 21 CFR Part 803,  21 CFR Part 806, 21 CFR Part 807 and 21 CFR Part 820 (US);
  • TG(MD)R Sch 1 and 3 (Australia);
  • MHLW MO169 and 128 (Japan). 
  • Law No. 16433 - Act on in vitro diagnostic medical devices (South Korea).

Our Quality Management System is designed to continuously improve customer satisfaction, the quality of our products as well as the effectiveness and the efficiency of our processes. The QMS is reassessed during Management Reviews and  Executive Quality Committees (EQC).

To fulfill our commitment to Quality, we are staffed by a competent, professional and continuously trained workforce.

Our objectives for the coming years are to maintain the ISO9001: 2015, ISO13485:2016 and Medical Device Single Audit Program (MDSAP) certification as well as to comply with the IVD 2017/746.

Established in Louvain-La-Neuve (Belgium) on 29th April 2021.

QUALITY POLICY

 - French version -  - English version

QUALITY CERTIFICATES

Certificate of approval ISO 9001: 2015

- Certificate of approval ISO 13485: 2016

- Certificate MDSAP-0079246

EXTERNAL CONTROL CERTIFICATES

BIORADBIORAD 2021- 25OH ELISA  | BIORAD 2021

DEQAS:   DEQAS 1.25 OH 2019-2020 | DEQAS 25 OH 2020-2021

INSTAND: INSTAND 102021-Pancreas Gastrointestinal Tract INSTAND 102021-Tumor Markers | INSTAND 102021-Hormones Virilization

UK NEQAS: UK NEQAS registration certification 2021-2022

RfB: Certificat RIA 2021 - Certificat ELISA 2020

PREVIOUS CERTIFICATES : on request

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