Emergo Group Videos and Pre-Recorded Webinars

How to Obtain Medical Device Approval in Latin America

Length: 55 minutes
South American medical device markets such as Argentina, Colombia and Costa Rica are getting more and more attention from foreign manufacturers. [Information current as of February 2012] (Includes link to download slides)

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Medical Device Approval and Compliance in Brazil

Length: 55 minutes
Per capita healthcare expenditures in Brazil are growing steadily and present a valuable opportunity for medical device companies. Learn how you can start selling your products in the Brazilian market in this free one hour webinar. [Information current as of March 2012] (Includes link to download slides)

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How To Get A Medical Device Approved for Sale in Canada

Length: 1 hour
With 35,000,000 people and a well organized healthcare system, Canada is an excellent market for medical devices. We'll explain the Canadian approval process step by step. [Information current as of February 2013] (Includes link to download slides)

The Medical Device Reimbursement Process in Canada

Length: 1 hour
Canada has experienced constant growth driven by universal access to health care, an aging population, and increase in chronic disease rates. We'll cover the process of Medical Device Reimbursement Canada in this one hour webinar. [Information current as of February 2012] (Includes link to download slides)

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The Medical Device Approval Process in China

Length: 36 minutes
The medical device market in China attracts many foreign manufacturers, but the CFDA (formerly the State Food and Drug Administration, or SFDA) approval process can be challenging. We cover major requirements involved in Chinese medical device approval, quality management system compliance, and more. [Information current as of March 2013] (Includes link to download slides)

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How to Obtain Medical Device Approval in Latin America

Length: 55 minutes
South American medical device markets such as Argentina, Colombia and Costa Rica are getting more and more attention from foreign manufacturers. [Information current as of February 2012] (Includes link to download slides)

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How to Obtain Medical Device Approval in Latin America

Length: 55 minutes
South American medical device markets such as Argentina, Colombia and Costa Rica are getting more and more attention from foreign manufacturers. [Information current as of February 2012] (Includes link to download slides)

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Medical Device Approval in Saudi Arabia and Egypt

Length: 58 minutes
The Middle East presents new opportunities for foreign medical device manufacturers. We will cover: registration costs and timelines, and importing and distribution issues, and more. [Information current as of January 2013] (Includes link to download slides)

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The European CE Marking process for medical devices

Length: 11 minutes
Explains the European CE Marking process and how to get a medical device approved for sale in the EU. Explains device classification, Technical File preparation, ISO 13485 quality system implementation, role of the EU Authorized Representative and Notified Body audits. Flow charts make the process easy to understand.

Conducting Medical Device Clinical Studies in Europe

Length: 1 hour
We provide an overview of European clinical study requirements and what you need to know to conduct a successful clinical study in the most cost effective and efficient manner. [Information current as of January 2012] (Includes link to download slides)

CE Marking: The Medical Device Approval Process in Europe

Length: 58 minutes
Europe has adopted a harmonized regulatory system called CE Marking. We'll explain the European CE Marking approval process step-by-step in this one hour webinar. [Information current as of August 2012] (Includes link to download slides)

Medical Device Distributors in Europe: Finding, Evaluating and Managing

Length: 45 minutes
The CE Marking process is harmonized; the process of finding and qualifying distributors is not. We explain evaluating and selecting the right distributors for your devices in European countries. [Information current as of Apr. 2012] (Includes slides)

How to Select and Make the Best Use of Your Notified Body

Length: 58 minutes
Selecting a Notified Body is crucial for device manufacturers seeking CE Marking in the EU. We cover the role your Notified Body plays in device registration and QMS implementation, and how to evaluate the firms offering this service to determine who is right for you. [Information current as of Sept. 2012] (Includes link to download slides)

Proposed Changes to Medical Device Legislation in Europe

Length: 60 minutes
cover recently announced changes planned for the medical device regulatory system in Europe. Once implemented, these changes will impact all medical device manufacturers and their partners doing business in Europe. [Information current as of November. 2012] (Includes link to download slides)

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Fast Access Markets: Singapore, Hong Kong and Other Emerging Markets to Consider

Length: 52 minutes
In this video we cover markets such as Singapore, Hong Kong and Israel, where manufacturers can take advantage of speedier time to market and expand their sales footprint. [Information current as of May 2012] (Includes link to download slides)

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The Medical Device Registration process in India

Length: 53 minutes
With nearly 1.2 billion people, medical device manufacturers are excited about the potential this market offers. Yet, India's regulatory process for medical devices is in a state of flux. We cover the regulatory process as it exists today along with changes expected soon. [Information current December 2012] (Includes link to download slides)

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The Medical Device Approval Process in Japan

Length: 57 minutes
Japan is the second largest medical device market (by country), representing about 10% of the world total. Learn why and how to access the Japanese market in this video. [Information current as of April 2013] (Includes link to download slides)

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How To Obtain Medical Device Approval in Mexico

Length: 58 minutes
Explains the medical device registration process in Mexico. Covers device classification, COFEPRIS regulations, Mexican Registration Holder, import requirements and more. [Information current as of October 2012] (Includes link to download slides)

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Recent Medical Device Regulatory Changes in Russia

Length: 55 minutes
Effective January 1, 2013, the Russian Federation introduced some regulatory changes which will affect medical device approval. [Information current as of March 2012] (Includes link to download slides)

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Medical Device Approval in Saudi Arabia and Egypt

Length: 58 minutes
The Middle East presents new opportunities for foreign medical device manufacturers. We will cover: registration costs and timelines, and importing and distribution issues, and more. [Information current as of January 2013] (Includes link to download slides)

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Fast Access Markets: Singapore, Hong Kong and Other Emerging Markets to Consider

Length: 52 minutes
In this video we cover markets such as Singapore, Hong Kong and Israel, where manufacturers can take advantage of speedier time to market and expand their sales footprint. [Information current as of May 2012] (Includes link to download slides)

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Medical Device Registration in South Korea and Taiwan

Length: 52 minutes
Medical device markets in South Korea and Taiwan are robust enough to warrant careful consideration from foreign manufacturers looking to expand their business in Asia. [Information current as of September 2012] (Includes link to download slides)

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Medical Device Registration in South Korea and Taiwan

Length: 52 minutes
Medical device markets in South Korea and Taiwan are robust enough to warrant careful consideration from foreign manufacturers looking to expand their business in Asia. [Information current as of September 2012] (Includes link to download slides)

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US FDA regulatory process for medical devices

Length: 7 minutes
Provides a short, high level overview of the US FDA medical device regulatory approval process. Talks about device classification, 510(k) applications, GMP quality system compliance, FDA registration and more.

Medical Mobile Apps: Is Yours Subject to FDA Oversight?

Length: 56 minutes
FDA regulation of mobile apps and the claims that turn an app into a regulated medical device; apps that are accessories to existing 510(k) cleared medical devices; compliance requirements for software developers; quality system requirements; and more. [Information current as of November 2011] (Includes link to download slides)

FDA 510(k): Medical Device Registration Process in the USA

Length: 57 minutes
We provide an overview of the process of obtaining clearance from the US FDA, breaking it down into understandable steps and explaining each one. [Information current as of October 2012] (Includes link to download slides)

Steps to Comply with US FDA QSR

Length: 57 minutes
In order to register your medical device for sale in the US, you must implement a quality management system compliant with FDA Quality System Regulations. [Information current as of November 2012] (Includes link to download slides)

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Steps to Implementing ISO 13485

Length: 58 minutes
Implementing a quality system compliant with ISO 13485 goes a long way toward meeting QMS obligations in major markets such as the European Union, Canada and Japan. This video covers the major steps needed to meet ISO 13485 requirements. [Information current as of May 2012] (Includes link to download slides)

Global Distribution Strategies for Medical Devices

Length: 58 minutes
Once you’ve secured registration for your medical device in your chosen markets, how will you actually go about selling your product? Learn how to develop distribution plans for multiple markets, as well as how to determine which distributors best fit your commercialization plans. [Information current as of May 2013] (Includes link to download slides)

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