Emergo Group Videos and Pre-Recorded Webinars

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)

How To Get Your 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 device manufacturers. We'll explain the Canadian approval process step by step. [Information current as of December 2011] (Includes link to download slides)

The Medical Device Reimbursement Process in Canada

Length: 55 minutes
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)

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 February 2012] (Includes link to download slides)

Medical Device Distributors in Europe: Finding, Evaluating and Managing

Length: 45 minutes
While the CE Marking regulatory process is harmonized, the process of finding and qualifying distributors is certainly not. We'll tell you how to find, evaluate and select the right distributors for your devices in countries throughout Europe. [Information current as of April 2012] (Includes link to download slides)

The Medical Device Registration process in India

Length: 57 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 will explain the regulatory process as it exists today along with changes expected soon. [Information current as of March 2012] (Includes link to download slides)

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 2012] (Includes link to download slides)

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 December 2011] (Includes link to download slides)

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 January 2012] (Includes link to download slides)