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Resource Library for Medical Device Professionals

Resource Library for Medical Device Professionals

40 total results. Use the filters to narrow down the results.
Australia

What To Expect From Your Regulatory Representative

Are you planning to export your device to other medical device markets? Most countries require you to have a physical presence in that market. If you do not have an office there, you can appoint an independent representative to meet this need.

Brazil

Introduction to Brazil's Medical Device Approval Process

This video about the Brazil medical device market gives an overview of the regulatory framework and registration process basics.

Brazil

In Depth: Brazil Medical Device Approval and Compliance

This video series about the Brazil medical device market shows you the process and identifies the key concepts to know before you begin.

Brazil

What To Expect From Your Regulatory Representative

Are you planning to export your device to other medical device markets? Most countries require you to have a physical presence in that market. If you do not have an office there, you can appoint an independent representative to meet this need.

Canada

Introduction to Canada's medical device registration process

This video about the Canada medical device market gives an overview of the regulatory framework and registration process basics.

Canada

ISO 13485:2016: Six Key Differences for Medical Device Companies

This short video covers the 6 biggest changes in the new ISO 13485:2016.

China

China Medical Device Market Overview

China has one of the world's largest medical device markets. Medical device manufacturers see sales opportunities in China, but the regulatory process can be challenging. Interested in learning how to tap into this market? Th

Colombia

Introduction to Colombia's Medical Device Approval Process

This video about the Colombia medical device market gives an overview of the regulatory framework and registration process basics.

Europe

Introduction to Clinical Evaluation Reports (CER) for Europe

This video explores CERs, including what they are, why you need one, the research process, and contents and formatting.

Europe

Introduction to European CE Marking for medical devices

This video about provides an overview of the regulatory framework and registration process basics for devices.

Europe

ISO 13485:2016: Six Key Differences for Medical Device Companies

This short video covers the 6 biggest changes in the new ISO 13485:2016.

Europe

What To Expect From Your Regulatory Representative

Are you planning to export your device to other medical device markets? Most countries require you to have a physical presence in that market. If you do not have an office there, you can appoint an independent representative to meet this need.

Europe

Introduction to ISO 13485 compliance for Europe

In this video, learn more about the background of EN ISO 13485, and the steps you can take to obtain ISO 13485 certification in Europe.

Europe

In-Depth: Europe CE Marking Medical Device Approval and Compliance

This video series about the European medical device market shows you the process and identifies the key concepts to know before you begin.

Israel

Introduction to the Israel AMAR Medical Device Registration Process

This short video covers how to register your medical device with AMAR in Israel.

Japan

In Depth: Japan Medical Device Approval and Compliance

This video series about Japan's medical device market shows you the process and identifies the key concepts to know before you begin.

Japan

Introduction to Japan's Medical Device Approval Process

This video about Japan's medical device market gives an overview of the regulatory framework and registration process basics.

Japan

What To Expect From Your Regulatory Representative

Are you planning to export your device to other medical device markets? Most countries require you to have a physical presence in that market. If you do not have an office there, you can appoint an independent representative to meet this need.

Malaysia

Introduction to Malaysia's medical device approval process

This video about Mexico's medical device market gives an overview of the regulatory framework and registration process basics.

Mexico

In Depth: Mexico Medical Device Approval and Compliance

This video series about Mexico's medical device market shows you the process and identifies the key concepts to know before you begin.

Mexico

Introduction to Mexico's medical device approval process

This video about Mexico's medical device market gives an overview of the regulatory framework and registration process basics.

Mexico

What To Expect From Your Regulatory Representative

Are you planning to export your device to other medical device markets? Most countries require you to have a physical presence in that market. If you do not have an office there, you can appoint an independent representative to meet this need.

Russia

Introduction to Russia's Medical Device Approval Process

Russia is a promising market for medical devices, but the regulatory process can be challenging. Learn what's involved in this short video.

Saudi Arabia

Introduction to Saudi Arabia's Medical Device Approval Process

This video about Saudi Arabia's medical device market gives an overview of the regulatory framework and registration process basics.

Singapore

Introduction to Singapore's Medical Device Registration Process

This video about Singapore's medical device market gives an overview of the regulatory framework and registration process basics.

South Korea

Introduction to South Korea Medical Device Approval Process

This four minute video provides an overview of South Korea's medical device registration process.

South Korea

In Depth: South Korea Medical Device Approval and Compliance

This video series about South Korea's medical device market shows you the process and identifies the key concepts to know before you begin.

South Korea

What To Expect From Your Regulatory Representative

Are you planning to export your device to other medical device markets? Most countries require you to have a physical presence in that market. If you do not have an office there, you can appoint an independent representative to meet this need.

Taiwan

Introduction to Taiwan's Medical Device Approval Process

This video about Taiwan's medical device market gives an overview of the regulatory framework and registration process basics.

Taiwan

In Depth: Taiwan Medical Device Approval and Compliance

This video about the Taiwan medical device market shows you the process and identifies the key concepts to know before you begin.

United States

Introduction to the UDI System in the USA

This video describes key aspects of the FDA UDI system, why it is necessary, benefits, and when and how device manufacturers need to comply.

United States

Introduction to US FDA Medical Device Regulatory Process

This video about the United States medical device market gives an overview of the regulatory framework and registration process basics.

United States

In Depth: US FDA Medical Device Registration and Compliance

This video series about the United States' medical device market shows you the process and identifies the key concepts to know before you begin.

United States

In Depth: The US FDA 510(k) Clearance Process

In this 8-minute video, we discuss the steps you should take to prepare and submit a 510(k) to the US FDA.