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13 - SRM - Safety and Occupational Health


SRM 122 - Developing Effective Post-Market Surveillance in Medical Devices

Code Start Date Duration Venue Fees
SRM 122 10 November 2019 5 Days Istanbul $ 2950 Registration Form Link
SRM 122 08 December 2019 5 Days Istanbul $ 2950 Registration Form Link
SRM 122 26 January 2020 5 Days Istanbul $ 2950 Registration Form Link
SRM 122 23 February 2020 5 Days Istanbul $ 2950 Registration Form Link
SRM 122 22 March 2020 5 Days Istanbul $ 2950 Registration Form Link
SRM 122 19 April 2020 5 Days Istanbul $ 2950 Registration Form Link
SRM 122 17 May 2020 5 Days Istanbul $ 2950 Registration Form Link
SRM 122 14 June 2020 5 Days Istanbul $ 2950 Registration Form Link
SRM 122 12 July 2020 5 Days Istanbul $ 2950 Registration Form Link
SRM 122 09 August 2020 5 Days Istanbul $ 2950 Registration Form Link
SRM 122 06 September 2020 5 Days Istanbul $ 2950 Registration Form Link
SRM 122 04 October 2020 5 Days Istanbul $ 2950 Registration Form Link
SRM 122 01 November 2020 5 Days Istanbul $ 2950 Registration Form Link
SRM 122 27 December 2020 5 Days Istanbul $ 2950 Registration Form Link
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Course Description

Post market surveillance is an effective tool to handle crisis management and control public health.  The lessening credibility of the medical devices by the consumers and regulatory agencies has led to the popularity of post market surveillance.  This course will be focusing on the regulatory expectations for post market surveillance and explain the methods of applying the requirements to medical devices.  Topics consist of handling complaints, complaint systems inspections surveillancs systems, Medical Device Reports (MDR), implementation challenges, medical device tracking, impact of post approval studies and fulfilling compliance requirements.

Who Should Attend?

  • Recall Coordinators 
  • Research and Development
  • Manufacturing
  • Medical Directors
  • Clinical Affairs
  • Regulatory Affairs
  • Risk Management
  • QMS & Compliance Management 
  • Quality Assurance
  • Complaint Assessment & Handling
  • Post Market Surveillance

 

Course Details/Schedule

Day 1

  • Definition of Post Market Surveillance
  • Terminology:  surveillance, complaint, adverse event...
  • Lifespan of a medical instrument
    • Importance of risk assessment and risk management
    • Medical device design and manufacture:
    • Relationships with surveillance & complaint handling
  • Requirements for approval & post approval studies
  • Adverse event & vigilance reporting
  • Definition of a medical device report
  • GHTF SG2 guidelines
 

 

Day 2

Day 3

Day 4

Day 5