Integrating Clinical Evaluation and Risk Management

The webinar will discuss clinical evaluation, including the recommendations from MEDDEV 2.7-1 Clinical Evaluation: A Guide for Manufacturers and Notified Bodies. The training program will also cover MEDDEV 2.12-2 Guidelines on Post Market Clinical Follow-Up. Risk management, following EN ISO 14971: 2012, requires a risk management plan that includes activities related to collection and review of relevant production and post-production information. In this program, attendees will look at some approaches to write a post-production collection and review plan.

Why Should You Attend:

In developing, manufacturing, and providing medical devices, risk management is an important aspect. In the EU, risk management utilizes the harmonized standard EN ISO 14971:2012. Based on ISO 14971:2007, risk management includes collecting and evaluating post-production information. If post-production information reveals unrecognized hazards, unrecognized hazardous situations, or risk estimates that are no longer acceptable, then the manufacturer reexamines the risk file and the associated decisions.

Clearly, much of the post-production information will update the clinical evaluation as well as the risk management file. This webinar will detail developing requirements and provide an integrated approach. Participants will receive a checklist to help implement the requirements.

Areas Covered in the Webinar:

• Clinical evaluation requirements in the MDD
• MEDDEV guidance documents and how to use them
• Risk management requirements from EN ISO 14971:2012
• The role of the risk management plan
• Linking the sets of requirements to provide an efficient and comprehensive process

Who Will Benefit:

This webinar will provide 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