Medical Device Seminar Series
October 1, 2009 - FDA Premarket Notification [501(k)] and Premarket Approval (PMA) Workshop for Canadian ManufacturersTwo specialists from the U.S. Food and Drug Administration (FDA)’s Center for Devices and Radiological Health (CDRH), Rod Perez and Carole C. Carey, presented information that gives companies the critical knowledge and tools to reduce and/or eliminate their financial risk on entering the U.S. market. This workshop addressed these requirements in-depth, targeting manufacturers of medical devices and technologies and supporting institutional stakeholders.
How does the US FDA Regulate Medical Devices? - Carole C. Carey
What are the Regulatory Requirements for Importing Medical Devices into the US? - Carole C. Carey
The 510(k) Premarket Notification Process - Rod Perez
What is an IDE? Is Clinical Data Conducted Outside the US Acceptable? - Carole C. Carey
What is the Format and Content for a Premarket Approval (PMA) Submission? - Carole C. Carey
Establishment Registration and Device Listing - Rod Perez
Medical Device Reporting and Tracking - Rod Perez
October 16, 2008 - FDA and Regulatory Updates
This special workshop focused on recent FDA regulatory updates. Two experienced specialists, Martha Feldman and Bruce Haggar, deliver the most current updates ranging from pre-marketing regulatory affairs, and 510(K) submission, to combined products (drug/biotech-device; device-device) and quality system regulation. If your company is currently selling products in the U.S. or considering bringing the products into the U.S. market, this is a workshop not to be missed.
Martha Feldman
510(K)
Clinical Trial Overview
Device Bench Study
Ethics and Regulations
IDE
Independent Charts
Medical Device Program
Meetings with FDA
Monitioring Clinical Trials
Monitoring Clinical Trails Part II
PMA
Postmarketing Requirements
References
Sponsor and Investigator Obigations
Bruce Haggar
GMP Qualigy System Regulations
CAPA Best Practices
Current FDA Trends
September 29, 2008 - Overview of Chinese Healthcare Market
This seminar featured the latest facts, figures and success stories about the world's fastest growing healthcare market presented by a team of experts flying in from China. Attendees were given an overview of China's life sciences sector, Chinese medical regulations, Intellectual Property Protection, and Tax Law.
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June 9, 2008 - EU Regulatory Environment 2008, Medical Devices & CE Marking in 2008
Dr. Evangeline Loh from Emergo Group presented the most recent updates of EU regulatory affairs including Medical Devices and CE Marking 2008, Directive 2007/47/EC Modifications to the Medical Devices Directive, as well as Vigilance.
Medical Devices and CE Marking in 2008
Directive 2007/47/EC Modifications to the Medical Devices Directive
Vigilance
Click here to view useful links related to this workshop.
October 29, 2007 - Health Canada Regulations on Medical Devices
This one-day seminar detailed the most recent Health Canada regulations on medical devices, and provided companies with everything they needed to know about bringing a device to market in Canada. The speakers were directly from Health Canada and covered a wide-ranged topics from classification rules, device/establishment licensing to medical device recalls.
Click on the following links to review seminar presentation materials:
Pre-market Information-Class III and IV
Licence Amendments
Investigational Testing Requirements
Canadian Rule Based Classification System (IVDD)
Medical Devices Licensing Requirements
Medical Devices Regulations Overview
Canadian Rule Based Classification System (non-IVDD)
Inspectorate Programme for Medical Devices
Recall Medical Devices
Medical Device Regulatory Inspection Program
Medical Device Regulatory Inspection Results/Examples
Medical Device Export Certificates
Medical Device Establishment Licensing
September 10, 2007 - Regulatory Affairs - From the FDA to ISO & CE-Marking
This seminar focused on medical device regulatory affairs topics including FDA product approvals, CE-marking and ISO certification. The speakers selected have broad experience in meeting regulatory requirements for medical devices. They shared their extensive knowledge and experiences with the audience and provided opportunities for questions and discussion related to the topics. This seminar targeted individuals responsible for regulatory affairs and quality systems in start-up companies as well as small to medium size companies that are looking to market their products in the US, Canada and Europe.
Click on the following links to review seminar presentation materials:
Medical Devices for the U.S.
Medical Devices for the E.U.
ISO 13485 Certification