Resources

Learn more about taking a strategic approach to achieve regulatory approval in medical device markets around the world.

Meet the human factors engineering (HFE) expectations, regulations and standards of a global marketplace.

Watch our Emergo by UL subject matter expert as they outline the latest updates about US FDA electronic Submission Template and Resource (eSTAR).

This presentation, presented in Portuguese, reviews the resources of the European Commission.

Develop a greater understanding of the importance of incorporating human factors engineering (HFE) into post-market surveillance activities.

Our white paper explains the FDA’s risk-based classification system for medical devices.

In this webinar, our Emergo by UL expert outlines the latest updates on how the IVDR impacts intended purpose and classification.

Read this white paper to learn about FDA requirements for clinical evidence.

Regardez maintenant : le logiciel en tant que dispositif médical (SaMD) : considérations réglementaires UE/USA

In this webinar, our Emergo by UL subject matter expert outlines the latest updates about preparing for IVDR certification regulation updates.

Learn about EUDAMED database compliance requirements for medical device and in-vitro diagnostics (IVD) companies in Europe.

In this webinar, our Emergo by UL subject matter expert outlines the latest EU market regulatory updates.

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