World Conference Calendar

35105 Conferences

Integrating Clinical Evaluation and Risk Management (ISO 14971)

Added by Referral on 2010-09-17

Conference Dates:

Start Date Start Date: 2010-10-07
Last Date Last Day: 2010-10-07

Conference Contact Info:

Contact Person Contact Person: admin
Email Email:
Address Address: 2600 E. Bayshore Road, Online Event, CA, 94303, United States
Phone Tel: 650-620-3915
Phone Fax: 650-963-2556

Conference Description:

This clinical evaluation & ISO 14971 training will discuss how the new changes in MDD and the risk management requirements per 14971 overlap and how manufacturers can establish one integrated system to meet both the requirements.

Why Should You Attend:

The changes to the Medical Device Directive (MDD) should be in place by now. However, many manufacturers didn't recognize the March 21, 2010 was the final date for compliance, rather than the start of the transition period. One of the new requirements has the device manufacturer update the clinical evaluation (and its documentation) with data obtained from the post-market surveillance.

Related Technical Documents:

* Medical Device Directive (MDD)
* EN ISO 14971:2009 Medical devices - Application of risk management to medical devices
* MEDDEV 2.7/1 rev.3 Clinical evaluation: Guide for manufacturers and notified bodies
* MEDDEV 2.7/2 Guide for Competent Authorities in making an assessment of clinical investigation; notification
* GHTF SG5/N1R8:2007 Clinical Evidence – Key Definitions and Concepts
* GHTF SG5/N2R8:2007 Clinical Evaluation
* GHTF/SG5/N4:2010 Post-Market Clinical Follow-Up Studies
* NBOG CL 2010-1 Checklist for Audit of Notified Body’s Review of Clinical Data/Clinical Evaluation

Who Will Benefit:

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

* Quality Managers
* Regulatory Affairs Managers
* Risk Managers
* Management Representatives
* Design Engineers
* Notified Body Contacts
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