Where Design Control Meets Risk Management: A Lifecycle Approach for Medical Devices – Webinar Recording/Transcript
Product Details
Effective design control is essential to ensuring your product is fit for its intended use — and that it meets regulatory requirements.
But risk management also plays a critical role as the design of a medical device or IVD evolves and throughout a product’s lifecycle. An effective design control and risk management process helps to quickly identify and address safety and performance issues observed in manufacturing or by customers.
To implement a world-class program for medical devices that fulfills FDA and international regulatory requirements, don’t miss this webinar, led by Dave Petrich, vice president of quality and regulatory at the Landrich Group.
Petrich will explain the critical relationship between design control and risk management throughout the medical device development process as well as the regulations you will need to comply with throughout the process.
In addition, you’ll learn how to implement best-in-class processes to avoid adverse inspection findings and minimize delays in product approvals. You will come away with a better understanding of how to deploy design control and risk management processes to mitigate safety and performance issues.
Presentation Takeaways:
- Key definitions for design control and risk management
- The latest regulations associated with design control and risk management, including 21 CFR 820.30
- Lessons learned from 483s/warning letters
- Best practices for design control and risk management, such as FDA recommendations in Design Control Guidance for Medical Device Manufacturers
Don’t miss this chance to gain key insights from a top expert in the field.
Meet Your Presenter
Dave Petrich, vice president of quality and regulatory at the Landrich Group, is the former quality site head and senior director of design quality assurance at Roche Molecular Systems. He has been a quality and regulatory executive for more than 20 years, leading crossfunctional teams to develop, manufacture and commercialize in vitro diagnostics and medical device products. He has expert knowledge of quality management system processes, specializing in design and development, clinical trials/performance evaluations, manufacturing and postmarket support.
Who Will Benefit
- Regulatory affairs
- Quality assurance
- Compliance specialists
- Design engineers