Course Description -
2020 is a year of significant change 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 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
Course Agenda
Day One
What is post market surveillance?
- Terminology: Surveillance, complaint, adverse event...
- Lifecycle of a medical device
- Importance of risk assessment & risk management
- Medical device design and manufacture:
- Relationships with surveillance & complaint handling
- Conditions of approval & post approval studies
- Adverse event & vigilance reporting
- What is a medical device report?
Requirements and effective strategies for surveillance & complaint handling:
- Is there a difference between post market surveillance & complaint handling?
- What is complaint handling?
- Parsing complaints from:
- Enhancement requests
- Personal preferences
- Service
- Business practices
- When does a complaint become a reportable event?
- Build your business case to management
- What is Post Market Surveillance if NOT Complaint Handling?
- Managing complaints and looking at trends
- Feedback loop to quality system
- Escalation & evaluation for field action
- Risk assessment/management
- HHE
Requirements and effective strategies for medical device reporting:
- US requirements for reporting
- Who does it apply to? Who is exempt?
- What is a reportable event?
- Reporting timelines
- MedWatch, MedSun & MAUDE
- European (EU) requirements
- MDD, AIMD & the new MDR
- What is an event?
- Reporting timelines
- EC Guidelines & vigilance systems
- EU: Eudamed & NCAR
Day Two
Post approval studies:
- Post approval/conditions of approval studies
- Requirements
- 522 studies (post market surveillance)
- Registries
Medical device tracking:
- What needs to be tracked
- Usefulness of tracking
- UDI: in the US and the EU
- Requirements for tracking
Quality system considerations:
- More on the feedback loop to quality system
- Data to monitor, frequency of review
- Links to key QMS processes:
- Risk management
- CAPA
- Management controls
- Escalation
- Corrections, removals, and recalls
- Inspections
- Enforcement actions
Complaint handling system implementation challenges:
- Records
- Timeliness
- Decision making – who decides what?
- Field service
- Trending – separating 'real' from 'noise'
- MDR-reporting & second guessing
- Global & multiple site implementation
- International product distribution & reporting
Related other topics:
- Pharma & AERS
- HHE's
- Competitors & complaints
- Inspections: Some do's & don'ts
Learning Objectives
By the end of this course, participants will:
- Know the requirements of post market surveillance
- Understand the similarities & differences between FDA & EU requirements
- Know the requirements for compliant & effective complaint handling
- Understand the differences between feedback, complaints & reportable events
- Know how post approval studies impact post market surveillance requirements
- Understand the compliance requirements & practical needs for medical device tracking
- Understand how Quality System requirements are linked to post market surveillance
- Understand the importance of decision making, escalation & timeliness
- Understand the challenges of implementing a compliant & effective complaint handling system
