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)
Course Brochure
New brochure coming soon!
Course Description
The last few years have seen significant changes to Medical Device requirements with a far greater focus on Post Market Surveillance and product performance – a direct result of both users and regulatory agencies demanding more transparency to medical device risks and product performance.
Helping focus this greater emphasis on Post Market Surveillance are significant changes to:
- The EUs Medical Device Regulations replacing the (AI)MDD/IVDD in May 2020.
- The new regulations including updated and new requirements for Post Market Clinical Follow-up Studies (PMCFS), 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 period in March 2019.
- ISO 14971 Medical Device Risk Management standard - Edition 3 released in December 2019.
- FDAs CDRH 2018-2020 strategic priorities transitioning from a risk-based framework for medical device regulation to a benefit-risk framework, thus creating greater alignment with EU requirements including consideration of ‘state of the art’.
The 15 hour course provides 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.
Topics include:
- Complaint handling & vigilance systems
- Medical Device Reporting
- Post Market Surveillance and Risk Management
- ISO 14971 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 & MDR
- Compliance requirements & 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 course 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 & Medical Device Reporting
- Complaint Assessment & Handling
- Quality Assurance
- QMS & 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.