MDUK - Post Market Surveillance and Vigilance for Medical Devices

Rotherham , UK
Tuesday, 18 March 2014
MDUK - Post Market Surveillance and Vigilance for Medical Devices
Tuesday, 18 March 2014 08:30 -
Wednesday, 19 March 2014 17:00 (GMT)

AMP Technology Centre
Advanced Manufacturing Park - Brunel Way
+44 (0)114 254 1200
S60 5WG
United Kingdom

Map and Directions

About This Course

 This course is for manufacturers wishing to implement good Post Market Surveillance (PMS) and Vigilance processes in order to meet the regulations and, just as importantly, to keep themselves informed of the actual performance of their products in the market place. Such information will enable manufacturers to ensure continued customer satisfaction and to minimise any loss of confidence and liabilities arising in the event of problems.

A further driver for getting it right is that medical device regulators have noted, and are starting to focus on, the wide variations between how different manufacturers implement the EU Directives’ requirements for PMS and Vigilance.

The aim of a PMS system is to gather information on the performance of the product once it has been placed on the market and exposed to a wide variety of users, use environments and patients.

Vigilance is the name for the obligation to report ‘serious’ incidents to Competent Authorities and the course will explore what should and should not be included in order to avoid under-reporting (which forfeits confidence of the regulator) or over-reporting (which creates unnecessary alarm).

This combined course is designed to provide a thorough understanding of the requirements for the PMS and Vigilance processes, including their implementation for medical devices of all types, complexities and risk classifications. The courses will provide you with our ‘trademark’ practical advice on what to do to achieve cost effective PMS, both for your own purposes and in order to satisfy current and future regulatory expectations.

For those of you who are relatively new to the subject, day one provides an introduction and overview of these vital topics, while day two carries this further to provide you with the knowledge and practical interpretation you need to implement systems to meet the regulatory requirements. Although the course covers a lot of material, there will be time to explore the detailed aspects of the topics which cause you concern and the tutors will be available at all times to answer your specific questions.

Any medical devices manufacturer depends, for his success, on the knowledge, understanding and training of all the people involved in the company. Whether you are new to the industry or you have been working within the medical devices industry for many years, one or both of these courses could be for you!

Course Outline

Reasons for PMS and Vigilance and the Regulatory Background

  • Legal obligations for PMS
  • The role of the Competent Authority and Notified Body
  • How PMS feeds into clinical evaluation and Risk Management
  • The need for proactive PMS
  • Relationship between Vigilance and PMS
  • Importance of clinical evaluation and documentation
  • Monitoring competitors
  • Monitoring scientific and technological development
  • Notified Body verification of PMS implementation
Vigilance as a Sub-set of PMS
  • What are the legal requirements for Vigilance?
  • Variations between Competent Authorities
  • The Vigilance process: what to report and when
  • Indirect harm
  • Use error/abnormal use
  • Supply chain issues: re-sellers, agents, authorised representatives, own branders etc
  • Electronic reporting
  • Trend and periodic reporting
  • Differences between Competent Authorities
International Perspective
  • New developments in PMS around the world
  • Understanding the impact of these developments on industry
  • How do these compare to EU regulations?
  • What is expected?
  • Timelines
When Things go Wrong
  • Understanding what triggers remedial action
  • Statistical approaches – not everything is ‘normal’: Poisson and Bayes
  • Corrective action (CAPA and FSCA)
  • Negotiating with Competent Authorities
Emerging Requirements for PMS and Vigilance
  • Overview of the impact of the Directives Revision
  • Other expected changes
Exercises and Workshops will Illustrate
  • How to develop a proactive PMS process for different device types, complexities and risks
  • How to ensure that your PMS process gathers the relevant information
  • What needs to be reported as Vigilance in order to avoid under-reporting or over-reporting
  • How to implement procedures to recognise reportable incidents and to make reports in a timely manner

Who Should Attend

 This course is designed for Medical Device and IVD Regulatory Affairs professionals who wish to develop their understanding of PMS and Vigilance including professionals from regulatory, design and development, clinical affairs and those individuals handling complaints.

It will also be of interest to Quality Managers and those working in sales or marketing.

The introductory day will also benefit more senior personnel wishing to gain an overview of this activity which is so vital to maximising customer satisfaction and minimising product liability.


Contact Details

Payment Instructions

  • Payment Methods

    By Bank Transfer — We are happy to accept payment directly into our bank account so long as:
    • the full amount of the invoice is received net of all local and UK bank charges within 30 days from date of invoice
    • the payment timescale quoted at the bottom of our invoices is strictly adhered to
    • a remittance slip giving clear details of our invoice number is received at this office to coincide with the payment being credited to our bank account

    Our bank details will be sent with the invoice.

    By Cheque — Payment should be made by sterling cheque drawn on a UK bank and payable to NSF Health Sciences Ltd. Please ensure that the full invoiced amount, net of all local and UK bank charges, is received within 30 days from date of invoice. 

    Please note that, in both cases, if any bank charges are deducted prior to receipt, this amount will be re-invoiced to yourselves.

    By Credit or Debit Card — Using Regonline Secure Payment facility. Please note that if using this method a 2.5% service charge will be added to the total amount. The total purchase price (including VAT if applicable) and service charge will be displayed prior to confirming the order

    Payments — A VAT invoice (if applicable) will be provided (VAT Reg No. GB 927 3679 85). Settlement must be received at least 10 working days prior to the course start date. Cancellations within 25 working days of the course start date are subject to charges (see Cancellations section below). If a Purchase Order number is necessary to effect settlement of our invoice, please provide.

    Cancellations — Written cancellations with a full refund will be accepted up to 25 working days before the start date of the course. A fee of 50% will be payable for cancellations received between 10 and 25 working days before the start of the course. Full course fees will be charged for cancellations received within 10 working days of the course start date. Delegate substitutions may be made at any time up to the start of the course. Refunds will be made within 30 days of receiving the written cancellation by the same method that payment was made.

    Late Payment Clause

    We understand and will exercise our statutory right to claim interest at 2.5% above the prevailing Bank of England base rate under the Late Payment of Commercial Debts (Interest) Act 1998 if we are not paid according to our agreed credit terms.

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