About this course
A ‘soup to nuts’ series on gaining entry into the US for medical devices, this course takes you from the initial regulatory planning, preparing the necessary pre-market documentation such as the Pre Market Authorization and Pre Market Notification (510K). Our course will enable you to effectively plan and communicate through project management the steps necessary to achieve US regulatory approval. Day 3 and Day 4 then take you through the important aspects of developing a regulatory compliant quality management system, including an overview of the CFR21 Part 820 and implementation strategies that go beyond the basic understanding of requirements. Our course is a brand new course, aimed towards those European medical device manufacturers that wish to anticipate the journey from CE marked device to US regulatory cleared.
Who Should Attend
This course is for quality and regulatory affairs professionals, including:
- Employees responsible for product submissions
- Design development teams
- Employees responsible for product life-cycle management
- Management representatives
- Marketing personnel
Venue
AMP Technology Centre, Sheffield
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)1142541200
Fax: +44(0)1142541201
An NSF International Company 
