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Enroll three students in the same course (held on the same date and at the same location) at the regular price and receive a fourth enrollment for free. *This offer cannot be combined with any other promotional offer(s).

Medical Device Complaint Management and Vigilance Training

With a new emphasis on total life cycle management, regulators are increasingly turning their attention to postmarket regulations. Evidence can be seen in the new EU Medical Device Regulation, changes in ISO 13485:2016, and FDA guidance. Today you are expected to demonstrate that you have effective and proactive performance monitoring procedures. This is an area you cannot afford to ignore.

Over 3 engaging days you’ll cover a range of topics, including following postmarket surveillance best practices, addressing field corrections and recalls, and managing audits by global regulators (including MDSAP auditors).

Upcoming Dates and Locations

Please Contact Us if you need additional information or if you don't see a date that works for you. To register by phone, call 1.800.472.6477  |  On-Site training available, learn more »

Location Start Date Days Cost Public Course On-Site
Edison, NJ 08/06/2019 3 $2895.00 Add to Cart CONTACT US
Orlando, FL 08/27/2019 3 $2895.00 Add to Cart CONTACT US
Minneapolis, MN 09/17/2019 3 $2895.00 Add to Cart CONTACT US
Boston, MA 10/15/2019 3 $2895.00 Add to Cart CONTACT US
San Diego, CA 11/05/2019 3 $2895.00 Add to Cart CONTACT US
Chicago, IL 12/10/2019 3 $2895.00 Add to Cart CONTACT US

What You Will Learn

At the conclusion of this workshop, you will be able to:

  • Describe the role of risk management and CAPA in effective complaint handling, as well as key regulatory requirements for handling complaints, vigilance, and field actions.
  • Identify best practices for structuring your complaint-handling process and department.
  • Perform complaint intake, triage, investigation, and closure with confidence.
  • Identify reporting requirements in the US, EU, China, and MDSAP countries.
  • Understand PMS requirements, including those in the EU Medical Device Regulation (2017/745) and ISO 13485:2016.
  • Apply a risk-based approach to needed corrections and removals.
  • Prepare your team for audits of your complaint-handling system, including those by FDA, Notified Bodies, and MDSAP auditors.
  • Explain the relationship to risk management using ISO 14971 and linkages with corrections, removals, and recalls.

Who Should Attend

Quality and regulatory managers in medical device companies or anyone who needs to understand and apply the regulatory requirements for complaint handling and event reporting. All attendees must have a basic familiarity with FDA 21 CFR Part 820 and ISO 13485.

Number of Days: 3
CEUs: 2.5
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Bring any of our classes to your location - Oriel STAT A MATRIX on-site training is the perfect solution for training groups of five or more employees or launching a companywide training effort. It's cost-effective, completely customizable, and absolutely hassle-free. For more information, call 1.800.472.6477 or Contact Us.

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