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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.
Our consulting team in Tokyo delivers local expertise and support for companies seeking PMDA approval in Japan.
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 assists medical device companies with Foreign Manufacturing Establishment Registration (FMER) in Japan, including application compilation and regulatory guidance.
Emergo by UL offers qualified in-country representative and regulatory representation for over 500 medical device companies worldwide.
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 assists medical device companies with medical device classification, data management, and JMDN codes during clinical trials in Japan.
Emergo assists medical device companies with the PMDA medical device registration and approval process in Japan including Todokede submissions, Ninsho certification and Shonin approvals.
ANSWERED ON THIS PAGE:
What are the requirements for the Medical Device Single Audit Program (MDSAP)?
Which countries are participating in the MDSAP?
How can we achieve MDSAP certification?
Emergo can assist medical device companies with QMS compliance including Japan Ordinance 169 and the pharmaceuticals and medical devices Act (PMD Act).
Emergo assists medical device companies with registration for In-vitro diagnostics (IVDs) with expert knowledge, consulting and document preparation.
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