Risk Management for Medical Devices

(EN) ISO 14971:2019 Risk Management For Medical Devices

CLASSROOM INSTRUCTOR-LED TRAINING SCHEDULE

Date: 23rd - 24th March 2023
Time:
9 am to 4 pm ICT | 2 days


About the course

ISO 14971, Medical devices - Application of risk management to medical devices, details the risk management principles and practices as referenced in a number of key medical device standards, including the 3rd edition of IEC 60601-1 (electrical safety), ISO 13485 (quality management systems), IEC/EN 62366 (Usability of medical devices), ISO 10993 (biological evaluation) and IEC 62304 (medical device software). As such, compliance with the provisions of ISO 14971 is essential for manufacturers of medical devices.

This special (EN) ISO 14971:2019 Risk Management training program is intended as an introductory course to enable participants to have a basic understanding of Risk Management for Medical Devices which latest update to new version in 2019 recently. 

WHAT WILL YOU LEARN FROM THE COURSE?

Upon completion, participants will be able:

  • To learn why are we moving from a directive to a regulation, including understanding the background to the changes.
  • To understand what the new regulation is trying to achieve. Its key objectives and purpose.
  • To identify what the important changes are and their relevance to you as a manufacturer. 

Topics to be covered in the course include:

  • Overview, update change in version 2019
  • Risk management planning
  • Risk analysis, hazard and harm
  • Risk estimation and risk evaluation
  • Risk control measures and residual risk evaluation 
  • Post-production Information
  • Risk management file
  • Overview of the change
  • Exercise 

WHAT IS THE COURSE METHODOLOGY?

There is a balance between knowledge-based presentation, discussions, exercises and case studies.
Exam details:
Participants will be assessed through an examination at the end of the course. Minimum passing % criteria: 70%.

Certification details:
Participants who score 70% and above in the examination will be issued a TÜV SÜD Thailand’s course completion certificate.

Prerequisites: None

Venue:      TÜV SÜD (Thailand) Limited, Pathum Thani

Google Maps Directions

Fee (pre-paid):

  • THB 6,000 for regular attendee
  • THB 5,700 for ISO 13485 Certification Customer of TÜV SÜD Thailand

*Prices above are exclusive of 7% VAT.


About the Speaker

Paradee_Dolsook_Senior_Auditor_Medical_Health_Service

Khun Parawee Dolsook, Senior Auditor Medical Health Service - Khun Parawee Dolsook currently contribute and leads the Medical Health Service Division, in TÜV SÜD Thailand, He is responsible for contribution of division strategic management and growth of TÜV SÜD’s market share for Medical Health Services. He is a recognized Lead Auditor for various schemes, including ISO 9001, ISO 13485, MDD, MDR, MDSAP.

He has a keen sense of business acumen and well-honed leadership skills, with than a decade of industry experience relating to manufacturing, research & development and under his belt. Khun Parawee started his career with Molnlycke Health Care (Thailand) Ltd., where he was responsible for quality assurance leader of medical device products being manufactured by the company, his role was to ensure that the product conformed to the desired requirement and quality attributes, he has a great career path during the work experience in company in promotion to work globally in a Research and Development Department in a role of Assistant Product Care Manager to contribute the new medical device implementation project launch to the market. Khun Parawee Dolsook holds a Masters in Business Administration, Major Marketing Management (MBA) , and Bachelor’s degree in Science – Major in Public Health in Occupational and Safety (B.Sc.), Major 
Petrochemical and Polymeric materials (B.Sc.). 

Khun Parawee Dolsook holds a Master in Business Administration, Marketing Management from Ramkhamhaeng University, and a Bachelor’s 
degree of Industrial Technology Science in Major of Petrochemical and Polymeric Material from Silapakorn University and a Bachelor’s degree 
of Science Program in Occupational Health and Safety from Sukhothai Thammathirat University.

 

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