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Get right to it → Having strong integrated complaint and risk management processes is about more than just compliance. Watch this webinar and learn critical strategies and tactics for success.

 

A little more detail...
A seamless integration of risk management with complaint management has always been daunting for device manufacturers, even before the new requirements of the EU MDR and IVDR.

 

R&Q has supported many companies over the past decade with FDA 483's and warning letters related to complaint management issues that could have been avoided by having strong processes with clear linkages to risk management. It's also important to understand (and be able to communicate) that having strong integrated complaint and risk management processes is about more than just compliance.

 

Efficiencies in complaint handling and faster customer responses, easier identification of the risks associated with complaints so that resources can be focused on ensuring safe and effective products, and less frustration across the impacted resources across multiple functions, are outcomes that bring great value to the business!

In this webinar, R&Q will:

  • Present the variations in requirements across ISO 14971, 21 CFR, EU MDD and MDR, and IVDD and IVDR, and clearly define what's new;

  • Discuss the value of integrated complaint and risk management processes;

  • Define the data inputs and outputs for risk management and complaint management, along with  PMS reports, PMCF and CERs, and how they are interrelated;

  • Provide best practices for your quality system to ensure linkages between Risk Management, PMS, PMCF, and Clinical, to ensure data is consistently reported and flows between these subsystems; and

  • Provide guidance on how to share information throughout the organization to streamline processes and ensure consistency.

 


Presenters

Michael Wolford – Senior Principal Specialist
Regulatory & Quality Solutions (R&Q)

wolford_pic-minMichael is a Senior Principal Specialist with R&Q and has been in the medical device industry over 20 years holding positions in Mfg., Process Development, Quality and Regulatory with a focus on New Product Introduction, Compliance and Integration. He has extensive knowledge in risk management including initial assessment, remediation and integration and currently helps clients update and transition design and quality system documentation into the new MDR requirements.

 

Kyle Outlaw – Principal Engineer
Regulatory & Quality Solutions (R&Q)

K Outlaw head shot 2018-minKyle has over 20 years of quality engineering experience in the medical device and diagnostics industry, spanning design quality and process quality, with an emphasis on risk management, usability engineering, and verification & validation activities.  He has a Bachelor of Science in Manufacturing Engineering and a Masters in Manufacturing Management.  Kyle has created and overhauled risk management processes for Fortune 500 MD&D companies to bring them into compliance with ISO14971 updates, and has focused on Post-market Surveillance as a preemptive process.