Industries: Medical Device

Medical Devices: Developing Effective Post Market Surveillance and Complaint Handling Systems

Course Director: Jonathan Lee

 

Course Fee: $2150.00 Regular Registration / $1950.00 Early Bird (30 Days in Advance)

  Accreditation: ***RAPS Approved Course***

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
  • Medical Device Reporting
  • Risk Management & ISO 14971
  • Implementation challenges
  • Medical device tracking
  • Impact of post approval studies
  • Compliance requirements & meeting them
  • Complaint systems inspections.

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 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?
    • GHTF SG2 guidelines

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
      • Forms 3500, 3500A
  • 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
    • FDA
    • EU

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

Testimonials

"The Course Director gave very clear, realistic examples of how these topics relate to the industry. He knows his stuff! I was also very happy that he integrated the new EU MDR into the training although it was just released." Christina D., Device Safety Mgmt, Bayer
"Very knowledgeable, communicative, experienced instructor. Great take home sources, CD, mini books, etc. Great real-life examples were shared and discussed. Good sense of humor. Very good coordination of visual aids, flow charts, etc. Good Q/A schedules." Tasneem A., QS Auditor, NDC
"Instructor 'went the extra mile' by adding Recall discussion to address a student's question. I really liked his approach to asking everyone what they wanted to learn and then following up to make sure everyone's objectives were met. This was an excellent technique." Lynn B. Director of Quality, IOGYN
"Jonathan Lee was a very knowledgeable and engaging speaker. Wealth of information for us to consider and take in as we set up our new complaint handling systems." Arleen F. VP Quality, Argos Surgical
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