merger merger

Welcome to your new course portal!

On October 15th, hotcourses.com moved to findcourses.co.uk - which means you can now find all your favourite courses right here. Don't worry - you can still do all the things that you could do before.

All you need to do is search.

Show findcourses.co.uk as: Mobile

Post-Market Surveillance and Vigilance for Medical Devices

The Organisation for Professionals in Regulatory Affairs
Course summary
3 days
1,700 GBP excl. VAT
English
Professional Training
Next available date: 02/09/2020 13:00 - Online courses
Course Dates
London
02/09/2020 13:00  (English)
1,700 GBP
Online courses
02/09/2020 13:00  (English)
1,700 GBP

Course description

Post-Market Surveillance and Vigilance for Medical Devices

This Masterclass is also Module 16 of the MSc Regulatory Affairs and will help to define the terminology and explain the concepts of vigilance and post-market surveillance, their practical applications and integration into the lifecycle of a medical device. This course will focus on meeting European requirements.

Suitability - Who should attend?

This course is suitable for

  • Students of the TOPRA MSc programme
  • participants from the regulatory affairs industry who wish to develop their knowledge of the post market surveillance and vigilance for medical devices
  • participants from allied industries who wish to have a comprehensive understanding of the subject

Outcome / Qualification etc.

Benefits to participants

  • Be able to critically appraise a PMS system and make recommendations on the implementation of a PMS system
  • Be able to make recommendations and vigilance procedures
  • Demonstrate the ability to critically analyse the legal requirements relating to surveillance and vigilance
  • Critically appraise and evaluate communications from competent authorities, notified bodies, economic operators and other stakeholders relating to the conduct of surveillance and vigilance.
  • Critically evaluate the requirements and guidance for post-market market surveillance
  • Critically evaluate the requirements and guidance and vigilance
  • Possess a systematic understanding and critical awareness of the European requirements including legislation, guidance and associated documentation relating to surveillance and vigilance for medical devices.
  • Be able to critically appraise a PMS system and make recommendations on the implementation of a PMS system

Training Course Content

The Masterclass will cover the following areas:

  • European Regulatory requirements for PMS, including recalls and vigilance
  • Responsibility for PMS: Competent Authorities, Notified Bodies, manufacturers and other economic operators
  • Other Regulatory requirements – e.g. US MDRs
  • Guidance documents for PMS, including Commission, Notified Body and Competent Authority documents
  • Key elements of pro-active PMS including PMS system and PMS plan,
  • Role of the person responsible for regulatory compliance in PMS
  • Tailoring PMS systems to specific products, including drug device combinations and IVDs
  • Requirements of EN ISO13485, Quality Management Systems standard
  • Feedback of PMS data into the PMS plan, risk management, clinical evaluation, summary of safety and clinical performance, labelling and so on
  • PMS reports and periodic safety update reports (PSUR’s)
  • Vigilance including incidents, serious incidents, field safety corrective actions,periodic summary reports and trend reports
  • The electronic system on vigilance and PMS including public access
  • Exchange of information: PMS databases e.g. MAUDE and EUDAMED

Expenses

The full tuition price for students is 1500 GBP. The price for participants is 1700 GBP

About provider

The Organisation for Professionals in Regulatory Affairs

The Organisation for Professionals in Regulatory Affairs (TOPRA)

The Organisation for Professionals in Regulatory Affairs (TOPRA) has encouraged excellence in the area of regulatory affairs for pharmaceuticals, veterinary medicines and medical devices since 1978. TOPRA's mission is to represent and promote the profession of healthcare regulatory affairs globally....


Read more and show all courses with this provider

Request info

Fill out your details to find out more about Post-Market Surveillance and Vigilance for Medical Devices.

  Contact the provider

  Get more information

  Register your interest

Contact info

The Organisation for Professionals in Regulatory Affairs

3 Harbour Exchange, 6th Floor
E14 9GE London

 Show phone number

Request Information

Find out more about this Post-Market Surveillance and Vigilance for Medical Devices course - simply fill out your details:

Reviews

There are no reviews available yet.

U.K. L&D Report: 2019 - Benchmark Your Workplace Learning Strategy

Are you curious about the L&D strategies of some of the U.K.'s top companies?

Find out what they're up to in findcourses.co.uk's second annual U.K. L&D Report!

uk-ld-report-2019

Learn more

Similar Courses