Course Description - Course runs 9:00 to 5:00 both days (Breakfast & Lunch Included)
The changes to the EU post market requirements for Medical Devices are extensive – a direct response to users and regulatory agencies becoming less ‘tolerant' of medical device risks and failures.
A far greater emphasis placed on Post Market Surveillance improving Risk Management to protecting public health, places increasing requirements on Medical Device Manufacturers. This course will review the existing and emerging regulatory expectations (FDA, EU and others) for Post Market Surveillance including the new EU Requirements for Clinical Evaluation and Post Market Clinical Follow-up (PMCF). The course outlines practical steps for developing and implementing systems and procedures to comply with the increasingly more stringent requirements for Medical Devices.
Topics include:
- Complaint handling & vigilance systems
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- Risk Management & ISO 14971
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- Implementation challenges
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- Impact of post approval studies
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- Compliance requirements & meeting them
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- Complaint systems inspections.
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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 reporting training course is intended for medical device professionals involved in post market surveillance, complaint handling and regulatory compliance; however, professionals in associated disciplines are encouraged to attend, including:
- Post Market Surveillance
- 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
