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A comprehensive list of medical device regulations in South Korea with links to the original documents.
Learn about the regulatory structure in South Korea and major medical device regulations.
This chart illustrates the steps in Taiwan's TFDA medical device approval process and includes a timeline of expected approval.
This video about Taiwan's medical device market gives an overview of the regulatory framework and registration process basics.
This white paper discusses how to register your medical device with the TFDA in Taiwan.
Interested in selling your medical device or IVD in Taiwan? Emergo offers a wide range of regulatory, representation, QA and other services for companies looking to enter this market.
This video about the Taiwan medical device market shows you the process and identifies the key concepts to know before you begin.
Use this interactive table to estimate how long it takes to gain approval in popular markets worldwide, along with associated costs.
Learn about the regulatory structure in Taiwan and major medical device regulations.
A comprehensive list of medical device regulations in Taiwan with links to the original documents.
In this white paper, we discuss how to determine if your wearable product is considered a regulated medical device by the US FDA.
Use this calculator to see how many calendar days it usually takes the US FDA to clear medical devices with the same Product Code.
This video about the United States medical device market gives an overview of the regulatory framework and registration process basics.
This video describes key aspects of the FDA UDI system, why it is necessary, benefits, and when and how device manufacturers need to comply.
This video series about the United States' medical device market shows you the process and identifies the key concepts to know before you begin.
Correct classification of a medical device is critical for identifying its proper regulatory route in the United States.
This chart illustrates the steps in the US FDA's medical device approval process and includes a timeline of expected approval.
Learn about the Unique Device Identification (UDI) regulation, how to obtain a UDI number, compliance deadlines, and more.
A set of standards published by UL to address medical device cybersecurity issues will soon be adopted. In this one hour webinar, we discuss various aspects of medical device cybersecurity and how the new UL 2900 standards map to FDA guidance.
US FDA 510(k)s have unique content and format requirements. Get an overview of preparing and submitting a 510(k).
A comprehensive list of medical device regulations in United States with links to the original documents.
In this 8-minute video, we discuss the steps you should take to prepare and submit a 510(k) to the US FDA.
Post-market surveillance is a regulatory requirement the US and Europe and helps you ensure your device's safety and effectiveness.
In a 510(k) submission, what testing is required by the FDA to clear the device? While testing requirements are easy to determine for some devices, other devices require intensive research.
Are you ready to launch your mobile medical app in the United States? Depending on the functionality of your app, you might need clearance from the US FDA.
Discover guidelines, tips, and other useful information about corresponding with the FDA about the clearance of your medical device.
In this video, we discuss what medical device companies should do (and what not to do) before, during, and after a random FDA audit.
When preparing a 510(k) submission for a device labeled as sterile, you should carefully consider which sterilization method to use because it will affect the FDA’s expectation.
Learn about usability engineering studies, including FDA requirements, standards, and how to conduct a usability study.
This white paper provides a high-level overview of the US FDA 21 CFR Part 820 and the implementation process, including timelines and strategies.
Interested in selling your medical device or IVD in the United States? Emergo offers a wide range of regulatory, representation, QA and other services for companies looking to enter this market.
This whitepaper discusses how to bring a novel device to the US market, including common pathways, exemptions, and the de novo process.