EU Medical Device CE Marking - Implementing

About this course

Address the requirements to implement CE marking processes within your organisation . Implement procedures for the appropriate classification routes (Class I, IIA, IIB and III) in Europe.

NOTE - As the regulatory framework is likely to change in the coming 18 months the course also discusses the potential impact of these changes.

Course outline

• Critically evaluate the regulatory pathways required for different device technologies, intended purposes and levels of risk
• Practice the technique of classification and determining the specific regulatory routes to market.
• Determine the procedures required within your organisation to ensure a smooth regulatory strategy and product to market process.

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

• 

  James Pink
  Medical Devices, Vice President
  

  • [email protected]
  • +44 (0) 1143 600868

What you've said

Having attended the week long Regulatory Strategies for Medical Devices module delivered by NSF Health Sciences in October 2013, I cannot recommend this course enough. It is suitable for professionals newly entering the medical devices regulatory industry, in order to provide broad understanding on each stage of the regulatory process, and is equally suitable for those wishing to update their existing knowledge base, due to the ever changing and complex medical device laws and regulations. The course material provided is extensive, however, pitched at the perfect level by the excellent tutor, in order to aid quick and thorough learning and facilitate some interesting group discussions. Very highly recommended!

Beverley Scott