Wednesday, 1 May 2019
9:00 am-5:00 pm EST
Alcon Laboratories, Inc.
11460 Johns Creek Parkway
Commons Building #3
Duluth, GA 30097
+1 678 415 3937
In 2019, the International Organization for Standardization (ISO) plans to issue a new version of ISO 14971. This new version also affects the EU, resulting in new annexes for the three directives and two regulations.
While the new version doesn’t make major changes to the risk management process, the details affect current practice. Device manufacturers will update risk management activities resulting in new procedures, new device risk management plans and revised risk management files. This workshop will provide the information you need to understand the new versions (international and EU) and effectively implement them. This is particularly important since the EU regulations (MDR and IVDR) also change risk management requirements.
The workshop will begin with an overview of risk management to provide a common framework for participants. This includes definitions from the new standard and illustrations of their application. The speaker will then explore the relationship between the Risk Management System (RMS) and the Quality Management System (QMS), specifically how these essential elements of the regulatory framework must work in conjunction with one another.
The presentation will also cover one of the areas of common misunderstanding: the relationship of the hazards analyzed in risk management and failures analyzed in a Failure Mode, Effects, and Criticality Analysis (FMECA), and why the FMECA is the wrong tool for this application.
And finally, the speaker will review the risk management process in the new standard as well as the relationship with the EU requirements. The new version is a process standard, so we’ll look at each process step and explain how to implement it. Workshop participants will receive some tools to assist with implementation, including an Excel workbook to implement the process and a template for a risk management plan.
This interactive program, hosted by Alcon Laboratories, Inc., is brought to you by the RAPS Atlanta Chapter and is intended to promote knowledge advancement and facilitate networking among local regulatory professionals. Don’t miss this unique opportunity for a deep dive into medical device risk management. Lunch will be provided to all attendees and RAC holders may claim six RAC recertification credits.
Dan O'Leary CBA, CQA, CQE, CRE, CSSBB, CIRM, president, Ombu Enterprises, LLC
Prior to 17 April:
RAPS Members: $89
On or After 17 April:
RAPS Members: $99