Medical Device Change Management – Webinar Recording/Transcript
Medical Device Change Management
If you’re involved in any aspect of quality management systems (QMS) for your medical device, you need a strong change management process in place to avoid change interaction, where one change type triggers another change type.
Being familiar with common methods for specific change types that affect everything from post-market design to corrective and preventive action is also key for a smooth medical device production process.
Join FDAnews and operational expert Dan O’Leary for a comprehensive overview. Mr. O’Leary will review best practices, processes and methods to support medical device change management. The presentation will cover change activities in FDA QSR, ISO 13485:2016, EU-MDR Article 10, and EU-IVDR Article 10.
- Familiarize yourself with the overarching change management process and methods
- Assess how to apply the process to specific change types
- Determine the change interactions in the change types
- Master how to apply the process to specific QMS requirements
- Identify the similarities and differences across QMS requirements
Ensure a consistent approach to your change management process and avoid problems associated with ad hoc methods.
Meet Your Presenter:
Dan O’Leary, President, Ombu Enterprises, LLC
Your webinar leader is Dan O’Leary, President of Ombu Enterprises, LLC, a company offering training and execution in Operational Excellence focused on analytic skills and a systems approach to operations management. Dan has more than 30 years’ experience in quality, operations, and program management in regulated industries including aviation, defense, medical devices, and clinical labs. He has a master’s degree in Mathematics; is an ASQ certified Biomedical Auditor, Quality Auditor, Quality Engineer, Reliability Engineer, and Six Sigma Black Belt; and is certified by APICS in Resource Management.
Who Will Benefit:
- Medical device manufacturers
- Design engineering managers and supervisors
- Regulatory affairs managers and supervisors
- Quality management managers and supervisors
- Risk management managers and supervisors
- Production managers and supervisors
- Quality managers