Resources

Vietnam Regulatory Approval Process for Medical and IVD Devices

This chart illustrates the DMEC approval process for medical devices in Vietnam and is available for download in the Regulatory Affairs Management Suite (RAMS).

Thailand Regulatory Approval Process for Medical and IVD Devices

The Thai FDA medical device approval process explained: This process chart illustrates the approval process for medical devices in Thailand and is available for download in the Regulatory Affairs Management Suite (RAMS).

Documents and adhesive notes on wall in an office

Effective Discovery and Design Methods – A Foundation for Success

Learn how to approach early research and design to quickly build a strong foundation of usability for new development efforts.

Manager reviewing reports by laying them out on a table

ISO 10993-1 and Biocompatibility

Learn more on how to conduct a biological evaluation ISO 10993-1.

Scientists and business people talking in a conference room

Understanding Europe’s In Vitro Diagnostic Medical Devices Regulation

Learn more about EU In Vitro Diagnostic Medical Device Regulations.

Early Communication with the FDA

Learn more about tips and other information to help you feel comfortable when corresponding with the FDA.

Doctor reading a tablet while working on a laptop

Clarifying the Complexity of Human Factor Engineering

Expectations among regulatory bodies are growing just as HFE methods become more and more complex. How will you meet the requirements involved with marketing a medical device?

Close up of a person making notes on a printed out report on a clipboard

2023 South Korea Regulatory Overview

In this webinar, our Emergo by UL subject matter expert outlines the latest updates on medical device regulatory requirements in South Korea.

Close up of a hand holding an instruction booklet

Knowledge Task Testing to Validate Instructions and Warnings

Learn about the FDA’s expectations for knowledge tasks and how to plan for and conduct knowledge tasks during usability testing.

Group of colleagues having a meeting while one presents on a board

Japan Regulatory Requirements – PMDA Pre-submission Consultation Program

In this webinar, our Emergo by UL expert outlines the latest updates on regulatory requirements in Japan.

Performance Evaluation – When, What and How to Prepare for EU IVDR (Presented in Portuguese)

Este webinar explica o conceito de Avaliação de Desempenho apresentado pelo IVDR 2017/746 e aspectos fundamentais a considerar para seu produto.

Child using an inhaler with the help of a doctor

5 Tips to Ease Nervous Participants During Product Evaluations

Learn how to improve feedback and reduce the nervousness in participants during medical device user research studies.