Integrating Clinical Evaluation and Risk Management

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

Instructor Profile:

Daniel O'Leary is president of Ombu Enterprises, LLC, a company offering training and execution in operational excellence, focused on analytic skills and a systems approach to operations management. Mr. O'Leary has more than 30 years’ experience in quality, operations, and program management in regulated industries including aviation, defense, medical devices, and clinical labs. He has a Master’s Degree in Mathematics; is an ASQ certified biomedical auditor, quality auditor, quality engineer, reliability engineer, and Six Sigma Black Belt; and certified by APICS in resource management.

Topic Background:

Medical devices sold in the European Union fall under the Medical Device Directive (MDD). The Essential Requirements in Annex I paragraph 6a says, “Demonstration of conformity with the essential requirements must include a clinical evaluation in accordance with Annex X.” This applies to all devices, regardless of class.

Annex X, section 1.1c, requires the manufacturer to update the clinical evaluation and its documentation using data obtained from post-market surveillance. This doesn’t specify the method, but does refer to a post-market surveillance plan for the device.

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