DAN O’LEARY 2012 - Integrating Clinical Evaluation and Risk Management

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Category Medical Device

Deadline: May 10, 2012 | Date: May 10, 2012

Venue/Country: Houston, U.S.A

Updated: 2012-02-14 21:08:42 (GMT+9)

Call For Papers - CFP

The changes to the MDD should be in place by now. However, many manufacturers didn’t recognize the March 21, 2010 was the final date for compliance, rather then the start of the transition period. For this reason, the webinar will include a discussion of clinical evaluation, including the recommendations from MEDDEV 2.7.1 (Rev. 3) Clinical Evaluation: A Guide for Manufacturers and Notified Bodies.

The webinar will also cover MEDDEV 2.12-2 Guidelines on Post Market Clinical Follow-Up.

Risk Management, following ISO 14971, requires a Risk Management Plan that includes activities related to collection and review of relevant production and post-production information. We look at some approaches to write a post-production collection and review plan.

The seminar integrates both approaches to provide a comprehensive method to implement the systems.

Get a Free Document by the speaker: MEDDEV 2.7-1 Clinical Evaluation: Guide for Manufacturers and Notified Bodies

Description of the topic

When the European Union’s changes to the Medical Device Directive (MDD) went into effect in March 2010, it created a requirement for Clinical Evaluation. Previously, some devices required clinical evaluation, but in the new version, every device class must have a clinical evaluation.

One of the new requirements has the device manufacturer update the clinical evaluation (and its documentation) with data obtained from the post-market surveillance.

Similarly, ISO 14971 requires the manufacturer to maintain a system to collect and review information about the device (or similar devices) in the post-production phase.

These two requirements overlap, so that the manufacturer could establish one integrated system to meet both sets of requirements.

This webinar explains each system, and show how they are related. The webinar uses guidance documents from the EU and the GHTF to help explain the systems and clarify the regulatory expectations.

Areas Covered in the Session

? The Overview

o Clinical Evaluation

o Risk Management

o Their touch points

? The Documents and the Sources

o EU Directives

o Harmonized Standards

o EU Guidance Documents

o NBOG Guidance Documents

o GHTF Guidance Documents

? Changes to the MDD

o Requirements for Clinical Evaluation

o Clinical Evaluation changes in Annex I

o Clinical Evaluation changes in Annex X

? Clinical Evaluation using MEDDEV 2.7/1

o Scope

o Stage 1 Identify the pertinent standards and clinical data

o Stage 2 Appraise each individual data set

o Stage 3 Analyze each individual data set

o Report

? Clinical follow-up using GHTF/SG5/N4:2010

o Objectives

o Design

o Study

o Implement

? Risk Management

o Status of ISO 14971

o Clinical Evaluation and Residual Risk

o Joint follow-up for Clinical Evaluation and Risk Management

Who will benefit (Titles)

This webinar provides information for people involved in risk management and clinical evaluation of medical devices.

People in the following roles can especially benefit from the knowledge in this webinar:

? Quality Managers

? Regulatory Affairs Managers

? Risk Managers

? Management Representatives

? Design Engineers

Notified Body Contacts

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