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 an introduction to the PMS and Vigilance processes, including their implementation for medical devices of all types, complexities and risk classifications. The course 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. 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 device manufacturer depends, for their 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, if you require an understanding of Post Market Surveillance and Vigilance this course could be for you!
Course outline
- What is PMS?
- Regulatory requirements for PMS and how these are interpreted in:
- ISO 13485
- ISO 14971
- Meddev and NB Guidance
- PMS procedures including both proactive and reactive sources of information
- Post-market clinical follow-up
- Reporting of complaints as Vigilance incidents
- Fitting it all together into the Product Lifecycle
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 
