Pharmaceuticals / BioTech

Our expertise

Medical Device and IVD Registration and Approval in Hong Kong

Emergo by UL can support you by gaining regulatory approval to sell medical devices and IVDs in the Hong Kong Market. This includes full support with the compilation of the registration dossier and acting as your representative.

Medical Device and IVD Registration and Approval in Thailand

Medical device and IVD registration with the Thai Food and Drug Administration (FDA). Get our local support for approval.

Get Full Access to OPUS™

Purchase individual, team, or enterprise subscriptions to scale your organization’s medical HFE expertise. Purchase a subscription on our HFE software platform, OPUS™.

OPUS™ Tools

Enhance your productivity with our premium and complimentary tools. Access complimentary and premium-level HFE tools on our software platform, OPUS™ – Optimal Product Usability Suite™.

OPUS™ eLearning

Develop a strong foundation on key HFE topics or earn a complete course certificate in Applying HFE to Medical Technology. Sign up for courses or earn your course certificates on our HFE software platform, OPUS™ – Optimal Product Usability Suite™.

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Singapore Vigilance Reporting for Medical Devices

Emergo by UL can help you implement a vigilance system for adverse event reporting, recalls and post-market monitoring as required by the HSA.

Hong Kong Medical Device Regulatory Strategy Report

Let Emergo assist you in evaluating the Hong Kong medical device regulatory framework as it applies to your device(s).

Meeting in front of a large information device about universal detection of genes in a specific biological sample.

South Korea Medical Device Vigilance Reporting

ANSWERED ON THIS PAGE:

When are vigilance reports required in South Korea?
What is considered a severe adverse event by Korean authorities?
What are the steps in the Korean vigilance process?

Latest Pharmaceuticals / BioTech news

The latest industry insights from our global team.

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May 16, 2023

Emergo HFR&D at the 2023 HFES International Symposium on Human Factors and Ergonomics in Health Care

Part 2 of our report on key human factors engineering themes at the 2023 HFES conference

May 14, 2023

Retroactive Interference in Training Decay Periods

How human factors engineering professionals can employ retroactive interference techniques to improve training outcomes

May 14, 2023

Understanding Different Users in Different Countries: Clinical Practice and Healthcare Systems

How medical device use and development are affected by differences in healthcare systems and clinical practices in different markets

Final rules for combination products, patient reports for medical device evaluation

Apr 19, 2023

Conducting Sharps Injury Prevention Tests

Injury prevention features and testing for injection devices

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