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Solveig Linko

7PUBLICATIONS
35CO-AUTHORS
Quality assurance, chemometrics, traceability and metrological chemistryRequirements engineeringMedical biotechnology diagnostics (incl. biosensors)Software quality, processes and metricsManufacturing safety and quality
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Journal

Publications (7)

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|Jun 19, 2026
Guidance in the application of quality management in the field of chromatography in routine medical laboratories - EFLM Committee: Accreditation and ISO/CEN Standards point of view.

|May 29, 2025
Regulating the future of laboratory medicine: European regulatory landscape of AI-driven medical device software in laboratory medicine.

Hikmet Can Çubukçu, Guilaine Boursier, Solveig Linko

|Jan 03, 2025
EN ISO 15189 revision: EFLM Committee Accreditation and ISO/CEN standards (C: A/ISO) analysis and general remarks on the changes.

Solveig Linko, Guilaine Boursier, Francisco A Bernabeu-Andreu

|Nov 18, 2023
APS calculator: a data-driven tool for setting outcome-based analytical performance specifications for measurement uncertainty using specific clinical requirements and population data.

Hikmet Can Çubukçu, Florent Vanstapel, Marc Thelen

|Jan 30, 2023
ISO 15189 is a sufficient instrument to guarantee high-quality manufacture of laboratory developed tests for in-house-use conform requirements of the European <i>In-Vitro</i>-Diagnostics Regulation.

Florent J L A Vanstapel, Matthias Orth, Thomas Streichert

|Nov 13, 2019
Validation and verification of examination procedures in medical laboratories: opinion of the EFLM Working Group Accreditation and ISO/CEN standards (WG-A/ISO) on dealing with ISO 15189:2012 demands for method verification and validation.

Roseri Roelofsen-de Beer, Jos Wielders, Guilaine Boursier

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Frequent Collaborators

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Marc Thelen

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Pika Meško Brguljan

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Guilaine Boursier

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Florent Vanstapel

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Francisco Bernabeu-Andreu

4 joint publications

Hikmet Can Çubukçu

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Duilio Brugnoni

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Neda Milinkovic

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Ines Vukasović

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Christos Kroupis

Frequent Collaborators

6 joint publications

Marc Thelen

6 joint publications

Pika Meško Brguljan

6 joint publications

Guilaine Boursier

5 joint publications

Florent Vanstapel