Module 2: Design, Risk and Product Validation - Understanding Design Control for Medical Devices

Monday, 20 October 2014
Module 2: Design, Risk and Product Validation - Understanding Design Control for Medical Devices
Monday, 20 October 2014 08:30 - 17:00 (GMT)

Manchester Marriott Victoria and Albert Hotel
+44 (0) 161 832 1188
Water Street
M3 4JQ
United Kingdom

Map and Directions


Address the requirements for design control of medical devices and discover the data necessary to support market approval for your device. Aligned to the requirements from Annex II of 93/42/EEC and ISO13485 Section 7.3 this course aims to ensure you have the appropriate processes to to demonstrate product safety and performance within a design process. 

Course Outline

  • Evaluate the design requirements defined in 93/42/EEC and ISO13485 – Compare implementation strategies for a design process in your own organisation
  • Establish the documentation requirements for capturing design input that addresses both product safety and functional performance – plan the necessary records within a QMS, design history and technical file
  • Discover the relationship between Risk Management, Harmonised Standards and the Essential Requirements in Annex I
  • Evaluate the planning, input, output, verification, validation and design review activities associated with good design control

Course Tutors

  • James Pink
  • Henry Sibun

The start and finish times given are approximate, please contact our office for further information.

Contact Details

Payment Instructions

  • Payment Methods

    By Bank Transfer — We are happy to accept payment directly into our bank account so long as:
    • the full amount of the invoice is received net of all local and UK bank charges within 30 days from date of invoice
    • the payment timescale quoted at the bottom of our invoices is strictly adhered to
    • a remittance slip giving clear details of our invoice number is received at this office to coincide with the payment being credited to our bank account

    Our bank details will be sent with the invoice.

    By Cheque — Payment should be made by sterling cheque drawn on a UK bank and payable to NSF Health Sciences Ltd. Please ensure that the full invoiced amount, net of all local and UK bank charges, is received within 30 days from date of invoice. 

    Please note that, in both cases, if any bank charges are deducted prior to receipt, this amount will be re-invoiced to yourselves.

    By Credit or Debit Card — Using Regonline Secure Payment facility.

    Payments — A VAT invoice (if applicable) will be provided (VAT Reg No. GB 927 3679 85). Settlement must be received at least 10 working days prior to the course start date. Cancellations within 25 working days of the course start date are subject to charges (see Cancellations section below). If a Purchase Order number is necessary to effect settlement of our invoice, please provide.

    Cancellations — Written cancellations with a full refund will be accepted up to 25 working days before the start date of the course. A fee of 50% will be payable for cancellations received between 10 and 25 working days before the start of the course. Full course fees will be charged for cancellations received within 10 working days of the course start date. Delegate substitutions may be made at any time up to the start of the course. Refunds will be made within 30 days of receiving the written cancellation by the same method that payment was made.

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