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• In-House IVD Readiness Check

  Expert strategies for ensuring compliance and continuity of in-house IVDs in routine practice

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In-House IVD Readiness Check

CHF 1790.-

The IVDR has introduced consistent and harmonized regulation of in-house IVDs (also known as LDTs, Laboratory Developed Tests) on a European level. Consequently, in-house IVD manufacturers shall demonstrate compliance with additional requirements regarding their quality management system and technical documentation.

Our IVD experts offer practical solutions to help you translate the new IVDR requirements into compliant documentation, ensuring acceptance by the authorities and enabling the continued use of your in-house IVDs in routine practice.

Our Readiness Check Includes:

3 Videos (in English)

In-House IVDs Key Concepts and Regulation

Introduction to QMS and Risk Management Requirements

Outline of Technical Documentation Requirements and Structure

2 Hours of Consulting

Our IVD experts will address your concerns and help you develop practical solutions to meet regulatory requirements.

Checklist

Our checklist aims to allow the laboratory to self-assess its readiness for meeting the requirements of Article 5(5) of Regulation (EU) 2017 / 746 (IVDR) and additional national requirements in EU member states and Switzerland.

Certificate of Attendance

After your consultation, you will receive a certificate of attendance. This certificate serves as official proof of your training in In-House IVD Readiness and can be presented to notified bodies and your employer.

Our Regulatory Experts

Our experts are excited to meet you in person and demonstrate the strategies for ensuring compliance of in-house IVDs in routine practice.

Alicja Ritz, PhD

Senior Regulatory Affairs Manager, IVD Expert

Valentin Chapuis

Senior Quality & Engineering Support

In-House IVD Readiness Check

This package includes online access to three videos on in-house IVD readiness, two hours of consulting, a checklist and a certificate of attendance.

CHF 1790.- (excl. VAT)

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