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.
Venue
AMP Technology Centre, Sheffield, UK
We have selected the Advanced Manufacturing Park (AMP) Technology Centre near Sheffield as its location and environment are ideal to centralise and control our services. Based in a region well known for its expertise in healthcare manufacturing technologies and supported by clinical and academic excellence, the Centre provides an ideal location for business events, meetings, seminars, training events and small scale trade shows. With free parking, proximity to the M1 and M18, and within an hour’s drive of Leeds, Manchester, Sheffield, Bradford, Nottingham and Leicester, it is a convenient and accessible location.
The AMP has been designed to accommodate a range of manufacturing related activities, from the work of fledgling engineering and technology companies to the University of Sheffield’s collaboration with some of the world’s foremost advanced manufacturing technology businesses, such as Boeing and Rolls Royce.
Hotel Accommodation
We have a block booking of bedrooms at both the Aston Hotel Sheffield and the Holiday Inn Rotherham-Sheffield at a specially negotiated bed and breakfast rate. Hotel reservations should be made directly with the hotel. Please quote ‘NSF’ at the time of booking.
Any charges made by the hotel as a result of you not taking up your reservation for any reason will remain your responsibility, therefore please ensure that you are aware of the hotel’s cancellation policy.
Aston Hotel Sheffield, to book please call the hotel on +44 (0) 1142 615690, quoting ‘NSF’.
Holiday Inn Rotherham-Sheffield, to book please call the hotel on +44 (0) 1709 830630, quoting ‘NSF’.
Venue Address and Contact Details
AMP Technology Centre
Advanced Manufacturing Park
Brunel Way
Rotherham
S60 5WG
England
Tel: +44 (0)114 254 1200
Fax: +44 (0)114 254 1201
Tutors
We believe that our team of experts are the best available. Not only have they got years of experience in the industry, but they are committed to tutoring and helping those inside the industry to improve and raise the standards. We understand that you attend courses to learn about the latest regulations and to get your questions answered.
Our experts for this course are:
What you've said
“Should have done this course 12 months ago when I first joined the surgical instrument manufacturing sector.”
“The course was great, I found it thorough and it helped me to understand [about medical device post-market surveillance]. Taken a lot away from today.”
An NSF International Company 
