An Integrated Approach to Quality Risk Management

Industry experts from Axendia and Sparta Systems discuss the value of quality risk management and its practical applications.

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Managing Risk to Improve Product Quality 

An effective quality risk management program enables Life Science manufacturers to proactively manage product quality and patient safety. Risk management is a top priority for regulators around the world with a special focus on combination products and medical devices.

Beyond compliance, manufacturers can achieve maximum value from their Risk Management program by deeply integrating it to their Quality Management System. In doing so, Life Science manufacturers can unlock process efficiency and enhanced signal and trend detection, leading to improved product quality and reduced patient risk.

In this webinar, learn:

  1. The value of Quality Risk Management: 
    • Why it is an important topic for combination product and medical device manufacturers.
    • Key differences between ICH Q9 and ISO 14971.
    • The new ISO 14971:2019.
    • Considerations when upgrading your Risk Management process.
  2. The benefit of having your QMS connected to your RM program.
  3. Practical applications of AI in Medical Device Risk Management.


Daniel R. Matlis, President

Dan is the Founder and President of Axendia, an analyst firm providing trusted advice to Life-Science Executives on Business, Technology and Regulatory issues. Dan has three decades of industry experience spanning the Life-Science value chain.

Dan Burns, Director
Sparta Systems

Dan is an established quality leader with proven consent-decree/warning letter remediation and FDA inspection experience, robust background, and expert knowledge of FDA, EU, and ICH requirements for pharmaceuticals and medical devices.

Nikhil Shah, Manager
Sparta Systems

Nikhil is an experienced Medical Device Quality professional with expert knowledge of medical device design controls and risk management. Nikhil has strong background in leading new product development, and quality remediation efforts supporting M&A.