Medical Devices: Developing Effective Post Market Surveillance and Complaint Handling Systems
Course Director
Course Fee
$2150.00 Regular Registration
$1950.00 Early Bird Pricing (Register 30 Days in Advance)
Future Live Stream Sessions (click to register)
Course Description
Over the past several years, global oversight of medical devices has resulted in stricter post-market accountability. Users and regulatory agencies now expect evidence of ongoing product safety and risk transparency. As a result, manufacturers must maintain well-documented post-market surveillance and complaint handling systems.
In this post-market surveillance and complaint handling course, Michael Drues, Ph.D., examines the regulatory and operational implications of these changes. It provides guidance on building and strengthening compliant systems that withstand regulatory scrutiny while supporting product performance monitoring.
Helping focus this greater emphasis on post-market surveillance are significant changes to:
- The EU's Medical Device Regulations, replacing the (AI)MDD/IVDD in May 2020.
- Expanded requirements for Post Market Clinical Follow-up Studies (PMCFS) and Clinical Evaluations
- Post Market Surveillance Reports (PMSR) and Periodic Safety Update Report (PSUR).
- ISO 13485:2016 Medical Devices — Quality Management Systems standard completing its transition in March 2019.
- ISO 14971 Medical Device Risk Management standard - Edition 3, released in December 2019.
- The U.S. FDA CDRH 2018-2020 strategic priorities transitioning toward a benefit-risk framework aligned more closely with EU expectations
Across the 15-hour post-market surveillance compliance workshop, participants will gain an understanding of these changes with practical steps for developing, transitioning and implementing systems and procedures to comply with these increasingly more stringent requirements for medical devices.
The medical device monitoring and surveillance course also explores compliant trending and signal evaluation, multisite and international reporting coordination, inspection considerations and decision-making consistency across distributed product portfolios. Emphasis is placed on maintaining an effective feedback loop to the quality system, including risk management, CAPA, corrections, removals and recall considerations.
Topics include:
- Complaint handling and vigilance systems
- Medical Device Reporting
- Post Market Surveillance and Risk Management
- ISO 14971 and its evolution to Edition 3
- Implementation challenges
- Trending requirements and methods
- Medical device tracking
- Impact of post-approval studies
- ISO 13485, cGMP 820, (AI)MDD and MDR
- Compliance requirements and meeting them
- Complaint systems inspections
- Dos and Don’ts
Throughout the course, examples and case studies, together with the extensive resource material provided, help participants apply these important concepts and requirements.
Who Should Attend
This medical device post-market surveillance systems training is intended for medical device professionals involved in post-market surveillance, complaint handling, incident reporting and regulatory compliance. Others encouraged to attend are professionals in associated disciplines, including:
- Post Market Surveillance
- Vigilance and Medical Device Reporting
- Complaint Assessment and Handling
- Quality Assurance
- QMS and Compliance Management
- Risk Management
- Regulatory Affairs
- Clinical Affairs
- Medical Directors
- Manufacturing
- Research and Development
- Recall Coordinators
Related Courses
- Adverse Drug Events – Reporting & Regulatory Requirements™
- Overview of FDA Regulatory Compliance for Medical Devices
- Design Control for Medical Device Professionals™
- European Regulatory Procedures - EMA and National Requirements
- Medical Device Process Validation Training for Professionals
- Overview of the New EU Medical Devices Regulations: MDRs, IDVR, CE Mark and Compliance, QMS Fundamentals
Registrant Information:
Each person attending a course will be asked to set up an Attendee Profile Account during the registration process. Creating an Account helps you view your order history and manage your training programs. If you are registering for others, please set up an Account in the Attendee’s name. If you are registering more than one person, you’ll need to set up a separate account for each Attendee.