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Emergo by UL's new human factors tool - provides training, tools, and resources.
Our software tools offer digital regulatory monitoring for medical device compliance and access to human factors engineering tools.
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TalkingPoints is a round-up of news, insights, and resources about human factors and usability for medical devices, IVDs, combination products, and more.
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Our global consulting team works from 20+ offices on six continents.
We provide submission preparation and classification consulting to help companies navigate COFEPRIS requirements.
We work with clients to solve their biggest challenges in regulatory affairs, quality assurance, and device risk mitigation.
Emergo helps medical device companies secure Certificate of Free Sale (CFS) for medical device exports to countries around the world.
Emergo can assist you with classification of medical devices in Mexico to meet COFEPRIS regulatory requirements.
Emergo by UL can help you with COFEPRIS medical device registration and approval to sell your product on the Mexican market.
ISO 13485:2016 is coming! Let Emergo help you transition from ISO 13485:2003 or ISO 13485:2012. Local offices throughout the US, Canada, Europe and Asia.
ANSWERED ON THIS PAGE:
What does ISO 14971 require?
How do I implement ISO 14971?
How do I apply the risk management system and concepts to my product?
Emergo by UL can act as an independent, local authorized regulatory representative for medical device and IVD manufacturers seeking global market access.
Emergo can help implement medical device vigilance reporting systems for adverse event reporting, recalls and post-market monitoring as required by Mexican COFEPRIS requirements.
Emergo by UL offers COFEPRIS Registration Holder Representation services for medical device companies seeking to sell their product in Mexico.
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