Risk Management for Medical Devices - Implementing EN ISO 14971

About this course

EN ISO 14971 is the harmonised standard adopted by the medical device industry for demonstrating that the clinical benefit of a device outweighs all technological and user related risks. ISO 14971 requires risks to be identified, controlled and evaluated with respect to the entire product lifecycle and, as such, requires the implementation of formal, structured Risk Management activities and processes throughout the organisation.

This course will provide you with the technical knowledge to adopt and implement Risk Management within your organisation; to cover the diverse activities of design, validation, manufacture, use, service and disposal of your devices. The course is designed to give you the knowledge and skills necessary to implement Risk Management in sufficient technical detail to be able to present your Risk Management activities with confidence to competent authorities and notified bodies as a basis for market approval.

Who Should Attend

• Design Engineers
• QARA professionals
• Consultants wishing to advise organisations on Risk Management
• Notified body auditors and reviewers
• Competent authority personnel wishing to understand the practical application of Risk Management
• Risk Management and Safety Managers

Course outline

• How to link clinical evaluation, research and design to Risk Management
• How to develop Risk Management plans for the lifecycle phases of your product
• What techniques to use in order to determine risk acceptability
• How to ensure your Risk Management information includes all known risks associated with your technology/device
• How to link risk management activities to critical ongoing processes such as validation, change control and post-market surveillance
• The advantages and disadvantages of the various risk analysis tools
• How to determine clinical benefit over risk
• How to evaluate the effectiveness of your risk controls
• Common approaches to risk controls in design, manufacture, use and labelling for safe use
• Best practice for Risk Management reporting
• How to prepare for an inspection of your Risk Management practices

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’.

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:

• 

  James Pink
  Partner, NSF-DBA Medical Devices
  

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

What you've said

This is a new course for NSF-DBA in 2012 and we will soon be able to provide you with feedback from our Medical Device program