Pharmaceuticals / BioTech

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Medical Device Vigilance Reporting in Mexico

Emergo can help implement medical device vigilance reporting systems for adverse event reporting, recalls and post-market monitoring as required by Mexican COFEPRIS requirements.

Medical Device Single Audit Program (MDSAP) Internal and Gap Audits

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OPUS™

Emergo by UL’s new cloud-based human factors engineering (HFE) platform, Optimal Product Usability Suite (OPUS), leverages training, tools, templates and regulatory guidance to help you stay ahead in your HFE activities.

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Medical Device Vigilance Reporting for ANVISA in Brazil

Emergo can assist medical device manufacturers selling in Brazil with vigilance systems for post-market monitoring and adverse event reporting.

Medical Device Vigilance Reporting in Australia

As your Australian sponsor, Emergo can help ensure that medical device vigilance (MDV) reports are made to the Therapeutic Goods Association (TGA).

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FDA eMDR Adverse Event Reporting for Medical Device Companies

Medical device manufacturers selling products in the United States must comply with post-market reporting requirements outlined by the US Food and Drug Administration (FDA) and submit adverse events electronically to the FDA for review.

Gap Assessment and CE Transition Strategy for Medical Device Manufacturers

MDR Gap Assessments and CE Transition Strategies

Emergo by UL's EU MDD to MDR 2017/745 gap analysis and strategy recommendations can help you make a smooth transition and avoid unforeseen challenges.

Expand Globally with Regulatory Reports

Explore new markets with regulatory insights categorized by country, device type, and device class.

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

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

May 14, 2023

Retroactive Interference in Training Decay Periods

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

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