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Regulatory Training

The structured and evaluated training programme offered by PlatoX® Academy translates regulatory requirements into practical, applicable learning content that can be seamlessly integrated into everyday laboratory work.

Expertise with certainty

Our expert training programme provides professionals with the critical knowledge and skills they need to effectively and confidently navigate complex compliance requirements in today's ever-evolving regulatory environment.

Training and certification

Take on a leadership role in your laboratory and become a sought-after expert on regulatory requirements. Whether you are a biomedical analyst or laboratory assistant, PlatoX® Academy will help you build confidence, professional expertise and a strong network.

The PlatoX® Academy was developed in close cooperation with Biomed Austria, the professional association of biomedical analysts in Austria. Thanks to the combined expertise of practitioners and professional representatives, the Academy offers practical, evaluated training programmes that provide laboratory professionals with targeted support in implementing complex regulatory requirements such as IVDR, ISO 5649 and GSPRs.

In coordination with Biomed Austria

What we offer

Achieve regulatory excellence

Überblick über die regulatorischen Anforderungen im Laborumfeld, insbesondere im Hinblick auf die IVDR in der EU.

Regulatorischen Anforderungen für In-House IVDs (LDTs) unter Berücksichtigung der IVDR und ISO 5649.

Regulatorische Kompetenz im Labor: Von CE-Kennzeichnung bis In-house-Testung
Einführung in die Regulatorik und in die Welt von In-house IVDs: Bedeutung und Anwendung in der Diagnostik
Von der Zweckbestimmung zum Verwendungszweck: Die Basis für regulatorische Konformität und klinische Relevanz (INTENDED PURPOSE)

Zweckbestimmung im Rahmen der IVDR und wie sie sämtliche regulatorischen Anforderungen beeinflusst.

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