Understanding ISO 13485:2016

Date: 27th March 2019
Time: 08:30 - 17:00
Duration: 1 Day
Venue: Rochestown Park Hotel
Address: Rochestown Rd, Douglas, Co. Cork
Event details

Understanding ISO 13485:2016

To understand the Medical Devices Quality Management System ISO 13485:2016

Content includes

Provide an insight to the use of ISO13485 as the basis for a Quality Management system implemented by medical device manufacturers

  • Review the requirements of ISO13485 and make comparisons to ISO9001:2012 and 13485:2012
  • Give participants an understanding of ISO13485 and its alignment to FDA’s Quality System Regulation
  • Assist participants in the relationship between ISO13485 and ISO14971- Application of risk management to medical devices
  • Identify what ISO13485 requires and also what is not required within the standard
  • Clarify process management in the context of the requirements of ISO13485
  • Give basic audit techniques in meeting the ISO13485 requirements

Who should attend: Personnel working in the Medical Technology Industry

For all queries on the event, please call the event organiser:
Michelle Reinecke-Quain, Tel: +353 61 431802

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Delegate cancellation policy

Any cancellations received in writing up to two weeks prior to the event are refundable. All bookings are provisional until full payment is received.

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Per delegate: €120.00
(plus VAT)
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