Research and Markets: Global Medical Device Regulations Conference: 14th, 15th of May 2015, Florida

DUBLIN--()--Research and Markets (http://www.researchandmarkets.com/research/nccx73/global_medical) has announced the addition of the "Global Medical Device Regulations - US, EU, Canada, Argentina, Australia, Brazil, India, Japan, Mexico, Russia, South Korea, Taiwan" conference to their offering.

This workshop is intended to provide guidance on medical device classification and registration requirements in these countries.

During this workshop (1st day), medical device regulations of twelve countries will be discussed.

On the second day, we will discuss ISO 13485, ISO 14155, ISO 14971, GHTF documents, and MEDDEV guidance documents, etc. for quality and adverse event reporting including group discussions facilitating interpretation, understanding, and implementation of medical device regulations.

Why Should You Attend:

Understanding global medical device regulations and requirement and adequate implementation of applicable medical device regulations can significantly expedite the regulatory processes, bringing innovative medical products to the global market faster and saving enormous amount of your unnecessary time, efforts and investment.

At this workshop, you will get familiar with medical device regulations of twelve (12) countries concerning medical devices, active implantable medical devices and in vitro diagnostic medical devices for adequate implementation and successful registration.

Background:

At this workshop, Dr. David Lim will walk you through to get familiar with the medical device regulations in the following 12 countries:

- United States

- EU

- Canada

- Argentina

- Australia

- Brazil

- India

- Japan

- Mexico

- Russia

- South Korea

- Taiwan

The following areas will be discussed during workshop:

- Medical device regulations in US, EU, Canada, Argentina, Australia, Brazil, India, Japan, Mexico, Russia, South Korea, Taiwan

- In EU, the following four Directives will be discussed.

- - DIRECTIVE 93/42/EEC Concerning Medical Devices (MDD)

- - DIRECTIVE 90/385/EEC Concerning Active Implantable Medical Devices (AIMDD)

- - DIRECTIVE 98/79/EC Concerning in vitro diagnostic medical devices (IVDD)

- - DIRECTIVE 2007/47/EC Amending MDD and AIMDD

- ISO 13485

- ISO 14155

- ISO 14971

- GHTF documents

- MEDDEV guidance documents

- - Clinical investigation

- - Adverse event reporting

Areas Covered In The Session:

- Medical device regulations in US, EU, Canada, Argentina, Australia, Brazil, India, Japan, Mexico, Russia, South Korea, Taiwan

- In EU, the following four Directives will be discussed.

- - DIRECTIVE 93/42/EEC Concerning Medical Devices (MDD)

- - DIRECTIVE 90/385/EEC Concerning Active Implantable Medical Devices (AIMDD)

- - DIRECTIVE 98/79/EC Concerning in vitro diagnostic medical devices (IVDD)

- - DIRECTIVE 2007/47/EC Amending MDD and AIMDD

- ISO 13485

- ISO 14155

- ISO 14971

- GHTF documents

- MEDDEV guidance documents

- - Clinical investigation

- - Adverse event reporting

For more information visit http://www.researchandmarkets.com/research/nccx73/global_medical

Contacts

Research and Markets
Laura Wood, Senior Manager
press@researchandmarkets.com
For E.S.T Office Hours Call 1-917-300-0470
For U.S./CAN Toll Free Call 1-800-526-8630
For GMT Office Hours Call +353-1-416-8900
U.S. Fax: 646-607-1907
Fax (outside U.S.): +353-1-481-1716
Sector: Medical Devices

Contacts

Research and Markets
Laura Wood, Senior Manager
press@researchandmarkets.com
For E.S.T Office Hours Call 1-917-300-0470
For U.S./CAN Toll Free Call 1-800-526-8630
For GMT Office Hours Call +353-1-416-8900
U.S. Fax: 646-607-1907
Fax (outside U.S.): +353-1-481-1716
Sector: Medical Devices