EU Medical Device Regulations - Comprehensive Compliance Training Course

Are you planning to export or import medical devices in the EU?

Medical devices cannot be shipped to Europe unless they are in full compliance with the European Medical Device Directive (MDD). The compliance requirements vary, depending on the classification of the device. It's not just the CE marking requirements that manufacturers and exporters have to worry about, but also the way the MDD is linked to the EU Clinical Trial Directive and ISO Certification on commercializing products. This package of three comprehensive webinar recording CDs will help medical device companies gain insight into EU regulations.

How It Works:

Each webinar CD has a series of modules. Our speakers have delivered the modules using PowerPoint slides.

This training is convenient to attend individually or in groups. You don't have to travel from your office. This means you can afford to have your whole team attend. As the webinar recording CDs are licensed to be used multiple times in a location, you can schedule the training as many times for as many groups/batches as you wish. Your team members will learn the material together; everybody will get the same information.

Webinar Topics:

The following webinars are included in this comprehensive training package:

• EU Medical Device Changing Regulatory Landscape; 2010 Changes Now and What Current Re-writes Hold for 2011-12
• CE Marking: Obtaining and Maintaining EU Compliance Under the Medical Device Directive
• Medical Devices: EU Directives, Guidance Documents, CE Marking Process and ISO Certification Programs

Who will Benefit:

These webinar recording CDs will be beneficial to the following:

Top management; Regulatory management; Quality Management; Sales and Marketing Management; Quality Engineers; Personnel involved in development and implementation of the QMS; Clinical research and medical operations; Project Managers; Product Development personnel; Manufacturing personnel; Researchers managing Medical Device R&D and Development; Quality Assurance such as GMP, GCP Auditors; Clinical trial supply personnel; CRO personnel; All personnel who need to understand the procedures and impact of placing Medical Devices on the Market in the EU (25 expanded countries)

Webinars included in the Package:

EU Medical Device Changing Regulatory Landscape; 2010 Changes Now and What Current Re-writes Hold for 2011-12 (73 Minutes)

This EU Medical Device webinar gives a detailed understanding of 2009-2010 changing requirements for developing and marketing Medical Devices in the European Union and the future effects of current changes in MDD and CE marking registration system.

Areas Covered in the Seminar:

• The purpose of the Medical Device Directives .
• The current regulatory situation in relation to Medical Devices in the EU and the changes coming into force in 2010 from Directive 2007 / 47 / EC .
• Meeting the New Requirements for Conformity Assessment by Product Type.
• Understanding the impact the Directive will have on developing and marketing new Medical Device products .
• An overview of key areas of the Directive.
• The current EU challenges with the CE Marking process, Auditing by Notified Bodies and Under-reporting of Device Adverse Events .
• The Options the European Commission have to fix the current Problems.
• Feedback the Commission has received from Stakeholders.
• What this feedback likely means for future Directive changes and Member State Legislation.

About the instructor:

Robert J. Russell, has more than 25 years of experience working with FDA and the Commission on technical issues as they relate to policy development, regulation, clinical trial and the medical device development process. He is the President of RJR Consulting, Inc. RJR Consulting Inc. specializes in understanding global regulatory issues for the pharmaceutical industry.

CE Marking: Obtaining and Maintaining EU Compliance Under the Medical Device Directive (Duration: 74 minutes)

This webinar discusses the recent changes to MDD (Medical Device Directive), how to identify non compliance areas, contents of the technical file and essential requirements document and how to select notified bodies for MD compliance.

Areas Covered in the Webinar:

• Device classification distinctions, and what that means to you in terms of compliance burden.
• Technical File contents and organization.
• Review and selection of your notified body.
• How to show compliance with the Essential Requirements.
• Changes to MDD and their implications.
• What is expected for clinical data.

About the instructor:

Jeff Kasoff ,RAC, is the Director of Regulatory Affairs at Life-Tech, Inc., a leading manufacturer of consumables and instrumentation in the urodynamic and pain management fields. Jeff is responsible for oversight of corporate compliance with domestic and international regulations, preparation of submissions, and is primary liaison with regulatory agencies and notified bodies. Jeff began his regulatory career as the first full-time employee of Optex Biomedical, a device start-up, where he initiated their regulatory policies and procedures and prepared their submissions. Jeff received his Regulatory Affairs Certification in 1996.

Medical Devices: EU Directives, Guidance Documents, CE Marking Process and ISO Certification Programs (90 minutes)

This webinar discusses the requirements of the Medical Device Directives, their linkage to the EU Clinical Trial Directive and the requirements of CE Marking and ISO Certification on commercializing products.

Areas Covered in the Webinar:

• The current regulatory situation in relation to Medical Devices in the EU.
• The purpose of the Medical Device Directives.
• Meeting the New Requirements for Conformity Assessment by Product Type.
• 2010 Directive Changes; Additional Requirements.
• Understanding the impact the Directive will have on developing and marketing new Medical Device products.
• An overview of key areas of the Directive:
• Scope of application and definition
• Essential Requirements
• Medical Device Type & Process Path
• Medical Device Technical File
• Clinical Investigations
• Clinical Evaluations
• Notified Bodies
• Gain a detailed understanding of all Guidance Documents available to assist in the implementation of these directives.

About the Instructor:

Robert J. Russell, has more than 25 years of experience working with FDA and the Commission on technical issues as they relate to policy development, regulation, clinical trial and the medical device development process. He is the President of RJR Consulting, Inc. RJR Consulting Inc. specializes in understanding global regulatory issues for the pharmaceutical industry.

Follow us :