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 pack of 5 best-selling training CDs for regulatory professionals provides information on how medical device companies can achieve compliance with the EU Medical Device Directive, obtain CE marking and fulfill ISO requirements.

Do not delay any more. Hurry ! Get the whole set at 55% flat discount.

All Modules:

Module 1: How to Prepare for the New EU Medical Device Regulations
Module 2: Medical Device CE Mark & Quality System Certification: Recent & Proposed Changes
Module 3: Medical Devices: EU Directives, CE marking, ISO Certification and the NEW Device Regulations coming to the EU
Module 4: Design History Files and Technical Files/Design Dossiers - Meeting U.S. FDA CGMPS and the EU's MDD Requirements
Module 5: Classifying Medical Devices - US and EU

Module 1 : How to Prepare for the New EU Medical Device Regulations - (Last Recorded Date: Nov-2017)

Areas Covered in the Webinar:

• Review of the structure of the new regulation
• Overview of impact areas of regulatory change
• Details examination of :
• Product Classification
• Clinical data PMS and PMCF/clinical evaluation reports
• Transition arrangements
• Technical documentation requirements
• Unique device identification
• Economic operators
• Technical data including risk management

Instructor Profile:

Richard Young (BSc (Hon) MSc, AIQA, ) Managing Director of Acclaim Biomedical Consulting Ltd, has worked in the Medical Device and In Vitro Diagnostic markets for over 25 years with a personal focus on regulatory compliance, process validation and risk management.

Module 2 : Medical Device CE Mark & Quality System Certification: Recent & Proposed Changes - (Last Recorded Date: Nov-2017)

Areas Covered in the Webinar:

• New approach directives & background
• IVD, MDD & Active Implantable Directive
• Impact of significant recent & proposed changes
• Competent Authorities & Notified Bodies
• Medical Device Directive vs. Regulation vs. ISO 13485
• Device classification
• Routes to CE marking under various MDD annexes
• Technical files vs. Guidance Documents
• Essential requirements
• Significant Changes Coming

Instructor Profile:

John Chapman, BS, MBA, RAC has over 35 years medical device regulatory experience and over 15 years experience with the European Union’s medical device directive, 93/42/EEC. John has led two device companies to ISO quality system certification and CE marking. He has performed regulatory due diligence on over a dozen acquisitions in the past 12 years, exposing him to numerous quality systems, including consent decrees as well as many notified bodies. RAB Accredited Lead Auditor Course Certificate1996. He earned his regulatory affairs certification (RAC) in 1998 and was a contributing author to 2004 Fundamentals of EU Regulatory Affairs, RAPS, 2004. He co-founded a local RAPS chapter and has been a speaker at these meetings and the annual RAPS conference.

Module 3 : Medical Devices: EU Directives, CE marking, ISO Certification and the NEW Device Regulations coming to the EU - (Last Recorded Date: May-2016)

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.
• 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.

Instructor Profile:

Robert J. Russell has been President of RJR Consulting, Inc. The company assists the pharmaceutical, medical device and biotech industries in understanding and complying with International Regulations affecting compliance, new product development, manufacturing and quality assurance. RJR has offices in Columbus, OH, Washington, DC, Brussels, Belgium with exclusive affiliates across Asia and Latin America. Bob has 28 years of past industry experience as a CMC specialist, R&D Director and Global Director of Regulatory Affairs for Merion Merrill Dow pharmaceuticals and Cordis-Dow medical devices. He has a BS / MS degree in Chemistry.

Module 4 : Design History Files and Technical Files/Design Dossiers - Meeting U.S. FDA CGMPS and the EU's MDD Requirements - (Last Recorded Date: Nov-2013)

Areas Covered in the Webinar:

• The U.S. FDA's DHF
• The EU's MDD and the Technical File / Design Dossier
• Design Control 'Over Time' vs. a Product 'Snapshot in Time'
• DHF "Typical" Contents
• TF / DD Expected Contents
• Parallel Approaches to Documentation -- Teams
• The DMR and DHR -- DHF "Deliverables"
• Some Future Trends to Consider
• FDA and NB Audit Focus

Instructor Profile:

John E. Lincoln, consultant, with over 24 years of experience, primarily in the medical device industry – has successfully designed, written over 50 ISO 14971-compliant Risk Management Files / Reports, including FMECA and FTA analysis, many in response to FDA 483 observation, which have subsequently passed FDA audit or submission scrutiny, and described in peer-reviewed technical articles, and workshops, world wide.

Module 5 : Classifying Medical Devices - US and EU - (Last Recorded Date: Jan-2017)

Areas Covered in the Webinar:

• Medical device definitions
• US Medical device classifications
• EU Medical Device Classifications
• Key Terms and definitions
• Explain General and Special Controls and how they are applied
• Types of medical devices
• How US Medical devices are classified
• How EU Medical devices are classified
• List and describe the applicable US and EU regulations for medical device classification

Instructor Profile:

Charles H. Paul is the President of C. H. Paul Consulting, Inc. – A regulatory, training, and technical documentation consulting firm. Charles is a management consultant, instructional designer and regulatory consultant and has led C. H. Paul Consulting, Inc. since its inception over 25 years ago. He regularly consults with Fortune 500 pharmaceutical, medical device, and biotechnology firms assisting them in achieving human resource, regulatory, and operational excellence. He is a regular presenter of webinars and on-site seminars in a variety of related subjects from documentation development to establishing compliant preventive maintenance systems.

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