Medical Device Risk Management Design Development and Product Validation

About this course

Aimed at all those involved with the product to market process within Medical Devices, this course will provide you with and understanding of the process of risk management and interaction with the design and development activities of an organisation. The course will introduce you to the concepts and process required for managing the risk in situations where you are not design responsible, but responsible for placing products on the market.

The course provides you with an understanding of how to identify, interpret and integrate the use of essential safety and performance requirements and medical device industry standards.

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

• Risk management concepts within Medical Devices
• The product development process and regulation
• Building an optimum design and development process
• Aspects of the design and development plan
• Understanding intended use, user requirements and performance claims
• Product specific performance standards
• Risk management in design and their interaction with essential requirements
• Creating product specification test methods and performance criteria
• Design verification and validation methods
• The design review process
• The design history file construction, its management and control
• Building technical files and design dossiers
• Auditing the design and development process
• Design control do’s and don’ts
• Risk management in the supply chain
• Process risk management
• Managing risk as an own brand label and virtual manufacturing
• Integrating a risk management process within your organisation

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:

• 

  James Pink
  Medical Devices, Vice President
  

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

What you've said

This is a new course for NSF-DBA in 2013 and we will soon be able to provide you with feedback from our Medical Device program