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6-hr Virtual Seminar: Medical Device Regulations and Evolving Requirements: Post Market Surveillance, Complaint Handling, eMDR, Recalls, UDI Regulations & Emerging Signals

Duration : 6 Hours

Susanne Manz,

Susanne Manz, MBA, MBB, RAC, CQA is an accomplished leader in the medical device industry with emphasis on quality, compliance, and six sigma. She has an extensive background in quality and compliance for medical devices from new product development, to operations, to post-market activities. She has a BS in Biomedical Engineerin Read more

The FDA continues to improve it tools and techniques in its mandate to protect the public health. Post-market activities including electronic reporting, UDI (Unique Device Identifier) requirements, and Emerging Signals. Guidance are all part of the evolution in expectations for Quality Systems for Medical Device companies. Implementation of requirements for electronic medical device reporting were key to reducing workload, improving analytics, and increasing speed in detecting and reporting issues. UDI (Unique Device Identifier) provides a means for more easily and accurately identifying, analyzing, and trending products and quality problems. And draft guidance on “Emerging Signals” is the next step in sharing quality concerns with the public to prevent potential harm. All of these changes reflect the evolution in thinking and quality system expectations for medical devices. Medical device companies need to understand the changing regulatory climate and prepare their strategy for the future. This webinar will help you understand the impact of the changes and help you prepare.

Complaint Handling and Medical Device Reporting are considered critical processes by the FDA in maintaining the public safety. Because they are so critical they are frequently inspected areas by the FDA. More importantly, complaints can be also be an early warning of issues with your products and customer problems. It is vital to have efficient and effective processes for managing, analyzing, trending, and reporting product problems. Failure investigations and CAPA are essential to understanding and resolving these quality problems. And corrections and removals are sometimes necessary. This webinar will cover the basics of these important quality system requirements. We’ll discuss the evolution of new requirements and how you can get ahead of the game.

Course Objective:

• Understand the changing expectations for medical device quality
• Understand the proposed guidance on “Emerging Signals”
• Understand other areas of change such as eMDR and UDI that allow faster and more precise information,
• analytics, and trending
• Discuss the implications of these changes
• Understand how to change your Quality Management System from Reactive to Predictive
• Developing a strategy for these evolving expectations

Course Outline:

• Complaint Handling and Medical Device Reporting Requirements
• Failure Investigations and linkage to your CAPA system
• Corrections and Removals
• Guidance on Emerging Signals
• Electronic MDR reporting
• Case for Quality
• Maturity Modeling and you Quality Strategy
• Moving from Reactive to Predictive Quality and Compliance

This Course will be completed in 3 Sessions -

Session 1:

10: 00 AM - 12:00 Noon

Complaint Handling and Medical Device Reporting

12:00 Noon - 01:00 PM - Lunch Break

Session 2:

01:00 P - 02:30 PM

Evolving Requirements and Expectations

02:30 PM - 02:45 PM - Comfort Break

Session 3:

02:45 PM - 04:00 PM

Developing your Quality and Compliance Strategy


What You Get:

• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points

Who Will Benefit:

• Quality Systems Specialists
• Quality and Compliance Specialists
• Internal Auditors and Managers
• Quality/Compliance managers or directors for Medical Device companies
• Quality Leaders wanting to strategize and prepare for future changes
• Auditors
• Senior Management

Please reach us at 1-888-844-8963 for any further assistance or if you wish to register

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Subject : 6-hr Virtual Seminar: Medical Device Regulations and Evolving Requirements: Post Market Surveillance, Complaint Handling, eMDR, Recalls, UDI Regulations & Emerging Signals

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