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The Risk Analysis of Medical Devices

The Risk Analysis of Medical Devices

Online Training Course on 24 – 28 October, 2021

For Those Who Are:

  • Involved in ensuring a Risk Analysis meets the requirements of the Saudi Medical Device Regulation.
  • Involved in ensuring a Risk Analysis meets the requirements of the EU Medical Device Regulation or the EU In Vitro Medical Device Regulation.
  • Meeting the requirements within ISO13485:2016.
  • Meeting the requirements within ISO14971:2019.
  • Quality Engineers or Regulatory affairs professional.
  • Managing Risk Analysis for Medical Devices.

Benefits Of The Course:

  • Practical exercises to incite discussion and accelerate learning.
  • Provides an open forum to air concerns and ask questions
  • Offers the opportunity to compare notes with industry peers.
  • A full set of course notes and guidance documents for post-course referral.

Course Modules:

Introduction
ISO 14971 Structure.
Definitions.
Regulatory Requirements.
Risk/Benefit Analysis.
MODULE 1 : Plan
Risk Management Plan.
Risk Management Procedure.
Use of the Regulation.
Hazard Analysis.
MODULE 2 : Analysis
Determination of Probability & Severity.
FMEA.
Fault Tree Analysis.
Links to ISO 13485.
MODULE 3 : PMS
PMCF.
PMS by Complexity.
Tying Severity and Occurrence to PMS.
MODULE 4 : Vigilance
Conducing Vigilance.
Setting Limits & Trigger Points.
Compilation of a Risk Analysis Report.
The SSCP and the PSUR.

Richard Tully, provides courses on Saudi, European Union and United Kingdom laws for medical devices, technical aspects of compliance and Quality Management Systems. Also, Tully provides Medical Device Consultancy including technical writing, auditing and QMS. This service extends to training and consultancy for the Saudi Food and Drug Administration. Tully has a background of 28 years in engineering. He began working with medical devices in 2004 when he designed and developed anaesthesia systems. Tully spent 6½ years at a Notified Body in the UK (BSI) as a Technical Expert and QMS Lead Auditor. His specialty was active medical devices. His main task was to assess technical documentation for CE marking in Europe. Tully conducted technical and quality audits on behalf of the Notified Body in many countries, concentrating mostly on the USA and Europe. And he has taught technical and quality aspects of the law all over the world to the public, companies, Notified bodies and Competent Authorities.