About this course
Background
By engaging successfully with this module a student will be able to
1. Critically analyse the medical devices Directives requirements for technical documentation.
2. Evaluate the benefits associated with using Information Technology to manage product technical information within an organisation.
3. Determine what data is required to ensure compliance with the essential safety and performance requirements.
4. Integrate the documentation requirements from the GHTF guidance on STED documentation to create effective summary document
What You Will Learn
You will develop in-depth knowledge, understanding and competence through a combination of lectures tutorials, course work and self- study. Lectures will be used to impart underlying principles and factual knowledge. The tutorials sessions will be used to explain and extend difficult concepts introduced during lectures. Independent and group literature research will introduce you to the literature on current Medical Devices practice. The tutor will also give guidance on the material for further self- directed study.
Course outline
• Typical documentation required by competent authorities, notified bodies and other interested agencies
• Managing the information distributed within your organisation
• Guidance documents produced by competent authorities, notified bodies and other interested agencies and the EU commission
• Summary technical evaluation documentation
• Utilising software to reduce duplication and increase the speed of distribution and review
• The competent authority review processes for technical documentation
• The notified body review process for technical documentation
• Document control principles
• Managing changes and supplements
• Presenting data necessary for compliance with the essential safety and performance requirements
Enjoy a discount by attending more than one course in this “Design & Development of Medical Devices” suite:
Please contact us for further details.
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
An NSF International Company 
