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  • In-House IVD Readiness Check

    Expert strategies for ensuring compliance and continuity of 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

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)

Contact and Billing Information

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Available weekdays for consulting: Monday - Wednesday

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