Live web conference Best Practices for Preparing for a Technical File for CE Mark

Website https://compliance2go.com/product/?pid=CP2014-356 | Edit Freely

Category Medical Device

Deadline: October 21, 2014 | Date: October 21, 2014

Venue/Country: Houston, U.S.A

Updated: 2014-10-03 15:44:17 (GMT+9)

Call For Papers - CFP

This webinar is intended to help you get familiar with how to prepare for a technical file and submit it to a notified body for CE marking purposes under directives governing medical devices: medical devices including in vitro diagnostic and active implantable medical devices. This webinar is further intended to provide guidance on the regulatory requirements set out in the applicable Directives, which help assure that medical devices are safe and effective for their intended use.

Understanding the EU regulatory and quality requirements can significantly contribute to meeting the requirements and achieving compliance fast, resulting in saving significant amount of time and efforts and bringing innovative medical products to the EU market faster.

This webinar will discuss EU directives and contents and format for a technical file. At the end of the webinar, you will have a great opportunity to improve your way of preparing for and managing your technical file for CE mark purposes.

Why should you attend :

This webinar is intended to help you get familiar with how to put together a technical file for CE mark in the European Union (EU) in accordance with three directives governing medical devices including in vitro diagnostic and active implantable medical devices.

Areas Covered in the Session:

How EU laws are made

Overview of EU Directives

Medical Device Directive (MDD)

Active Implantable Medical Device Directive (AIMDD)

In Vitro Diagnostic Device Directive (IVDD

2007/47/EC Amending MDD and AIMDD

CE Marking Principles

Device Classification

Contents and Format for a Technical File And Design Dossier

Content of Declaration of Conformity

Clinical Evaluation

Overview of ISO 13485, ISO 14155, And ISO 14971

GHTF/IMDRF and MEDDEV Guidance Documents

PASS-IT Recommendations/Suggestions

Who will benefit: (Titles)

CEOs

VPs

Compliance officers

Attorneys

Clinical affairs (associates, specialists, managers, directors or VPs)

Regulatory affairs (associates, specialists, managers, directors or VPs)

Quality assurance (associates, specialists, managers, directors or VPs)

R&D (engineers, scientists, managers, directors or VPs)

CROs

Consultants

Contractors/subcontractors

Webinar Includes:

Q/A Session with the Expert to ask your question

PDF print only copy of PowerPoint slides

60 Minutes Live Presentation

Certificate of Attendance