Module 2: Design, Risk and Product Validation - Understanding Risk Management - ISO14971 for Medical Devices

Manchester
Wednesday, 22 October 2014
Module 2: Design, Risk and Product Validation - Understanding Risk Management - ISO14971 for Medical Devices
Wednesday, 22 October 2014 08:30 - 17:00 (GMT)

Manchester Marriott Victoria and Albert Hotel
UK, HS, MD, MQP, M2, CR
+44 (0) 161 832 1188
Water Street
Manchester
M3 4JQ
United Kingdom

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Learn the process of Risk Management and the fundamental methods adopted by the medical device industry to demonstrate that the clinical benefit of a device outweighs its risks. From defining risk acceptability criteria to establishing the process to identify, evaluate and select appropriate control measures this course will enable you to implement a robust risk management process.


Course Outline

  • Evaluate the fundamental requirements from medical device regulation relating to risk management
  • Discover ISO14971 step-wise approach to risk identification, assessment, control and evaluation
  • Establish Risk Acceptability criteria and apply solutions for your own organisation
  • Learn risk management tools and activities from defining product characteristics to the preparation of risk management summaries for regulatory submission.

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.

    Late Payment Clause

    We understand and will exercise our statutory right to claim interest at 2.5% above the prevailing Bank of England base rate under the Late Payment of Commercial Debts (Interest) Act 1998 if we are not paid according to our agreed credit terms.

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