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Practical Exercises


work through case studies to determine the best PMS strategies with specific emphasis on data collection and use of internet


Using vigilance data to determine which cases require reporting and when they should be reported


Practical cases of what can go wrong in the eyes of Notified Bodies and Competent Authorities are discussed as well as practical crisis management


A simulated exercise using a real life  scenario – PMS, vigilance and enforcement. Delegates will assume the roles of the manufacturer, CA, NB and the user
Your Course Leader

Successful Medical Device & IVD Post Market Surveillance and Vigilance Reporting

Course Objectives

As a medical device or IVD manufacturer, it is imperative to ensure you are employing up-to-date procedures for post market surveillance to guarantee regulatory compliance and avoid product recall. This course will provide you with the latest updates on regulations for medical device and IVD PMS and vigilance, clarifying any grey areas to outline your responsibilities as the manufacturer.

Using a combination of theory and practical case studies, the course will allow delegates to develop the knowledge needed to build successful PMS strategies and understand the latest requirements and technologies for reporting vigilance.
This course will provide the knowledge you need to overcome every day problems and enhance performance, ensuring you are employing the most appropriate PMS strategies for your products.

Why you should attend

  • Ensure compliance and avoid product recall
  • Develop effective processes for monitoring risk
  • Prepare for the overhaul of the Medical Device Directive
  • Gain perspective on global developments for PMS and Vigilance

Who Should Attend?

This course is relevant to medical device and IVD regulatory affairs professionals who wish to develop their understanding of PMS and vigilance:

• Vigilance
• Regulatory Affairs
• International Regulatory Affairs
• Safety specialists
• Compliance Managers
• Quality Assurance
• Quality Compliance

Other Events That Will Interest You

Introduction to Regulatory Affairs for Medical Devices

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Regulatory Affairs in Latin America for Medical Devices

03 Dec 2015 - 04 Dec 2015
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Dates and Venues

01 Oct 2015 - 02 Oct 2015

Radisson Blu Edwardian Grafton, London



Connect with the PTI faculty! PTI is a global pharmaceutical training company with over 60 interctive courses focusing on Regulatory Affairs, R&D, Clinical, Business Strategy, Fine Chemicals, Biopharmaceuticals, Manufacturing, Medical Devices and Agrochemicals 

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