In Vitro Diagnostics

Introduction

Is your IVD getting re-classified under the new classification rules?

Are you ready for the extended requirements to your Analytical Performance Report and your Post Market Performance Follow-up? We can help your company transition to the new IVDR.

Regulatory Clarification

Determination of IVD class according to the new classification rules and identification of conformity assessment route and degree of notified body involvement.

Chemical and Analytical Support

With our experience in analytical chemistry and validation we can help you establish and document the analytical performance of your device according to the requirements in IVDR.

EU IVDR

Have you gathered sufficient clinical evidence for the performance of your IVD? We can assist you in writing or updating your Analytical Performance Report and your Performance Evaluation Report.

We can help you establish an excellent system for your Post Market Surveillance and write your Post Market Follow-up plan according to regulatory expectations.

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Pharma4ever A/S

Agervej 4, 4340 Tølløse

Denmark

info@pharma4ever.com
+45 42 70 20 90
CVR: 36436573