Clinical Evaluation and Risk Management

Duration: 90 Minutes
Medical devices sold in the European Union fall under the Medical Device Directive (MDD). The webinar includes a discussion of clinical evaluation, including the recommendations from MEDDEV 2.7-1 Clinical Evaluation: A Guide for Manufacturers and Notified Bodies. The webinar also covers MEDDEV 2.12-2 Guidelines on Post Market Clinical Follow-Up.
Medical Device Compliance
Instructor: Daniel O'Leary
Product ID: 501229
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. This presentation will look at some approaches to write a post-production collection and review plan.

Objectives of the Presentation
  • Learn the requirements from the MDD
  • Understand the MEDDEV guidance documents and how to use them
  • Learn the requirements from EN ISO 14971:2012
  • Understand role of the Risk Management Plan
  • Link the sets of requirements to provide an efficient and comprehensive process
Why Should you Attend
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.

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 14972:2007, 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 should re-examine 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. The webinar develops the requirements and provides an integrated approach.

Who can Benefit
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
Bonus Material
Participants receive a checklist will help implement the requirements.
$375
Recorded Session for one participant
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Recorded Session - How it works
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  • Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
  • Please click on the link to access the Recorded Session
  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
Instructor Profile:
Dan is the 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. Dan 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 Masters Degree in Mathematics; is an ASQ certified Biomedical Auditor, Quality Auditor, Quality Engineer, Reliability Engineer, and Six Sigma Black Belt; and is certified by APICS in Resource Management.
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