31 total results. Show all resources.
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.

7 min
Nov 22, 2016
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.

4 minutes
Sep 26, 2014
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.

14 min
Jan 8, 2015
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.

4 minutes
Mar 27, 2014
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.

5 minutes
Jun 27, 2017
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

4 min
Mar 27, 2014
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.

4 minutes
Oct 23, 2015
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.

29 minutes
Nov 9, 2015
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.

4 minutes
Sep 21, 2011
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.

4 minutes
Mar 15, 2016
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.

21 minutes
Feb 8, 2012
Israel

Introduction to the Israel AMAR Medical Device Registration Process

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

6 minutes
Dec 13, 2017
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.

17 minutes
Apr 4, 2012
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.

4 minutes
Jul 24, 2014
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.

4 minutes
Aug 27, 2015
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.

16 minutes
Jun 19, 2015
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.

4 minutes
Jul 24, 2015
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.

6 minutes
May 5, 2017
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.

4 minutes
May 27, 2015
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.

4 minutes
Feb 9, 2015
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.

15 minutes
Apr 7, 2015
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.

4 minutes
Sep 26, 2015
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.

4 minutes
Apr 24, 2015
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.

10 minutes
Feb 16, 2017
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.

8 minutes
Apr 23, 2018
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.

5 min
Nov 23, 2015
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.

24 minutes
Jan 25, 2012
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.

4 minutes
Sep 21, 2015
United States

Overview of the USA FDA Classification Process

This short video covers FDA classification, how to use the classification database, and useful tips for classifying your medical device.

7 min
Jan 12, 2016
United States

In Depth: 21 CFR Part 820 - FDA Quality System Regulation

In this video, we’ll take a look at 21 CFR Part 820, including an overview, key players, important sections, and how to maintain compliance.

11 min
May 18, 2016
United States

How to Prepare for an FDA Inspection

In this video, we discuss what medical device companies should do (and what not to do) before, during, and after a random FDA audit.

4 minutes
Aug 9, 2016