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

ABOUT THE (EN) ISO 14971:2019 RISK MANAGEMENT FOR MEDICAL DEVICES

Date: 27 - 28 November 2024 

Time: 9 am to 4 pm ICT | 2 days instructor-led training

Fees: Early bird rates available

Risk management is one of the primary requirements for demonstrating compliance and conformance with medical device manufacturers' quality management system requirements. Analysing the reasons for product failures often leads to inadequacy in understanding and implementing risk management in the organisation.

This (EN) ISO 14971:2019 Risk Management training program covers a wide range of topics. It is designed to help participants at all levels, from beginners to advanced, understand and interpret standard requirements effectively with the discussion over the latest version in 2019.

WHAT WILL YOU LEARN FROM THE COURSE?

Upon completion, participants will be able:

• To learn the importance of the role of this standard for medical device QMS.
• To grasp the intended requirements and goals for ensuring the safety and performance of medical devices.
• To help manufacturers recognise key figures, purposes, and elements required to comply with this standard and meet regulatory requirements effectively.

Topics to be covered in the course include:

• Overview of standard content for this 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
• Exercise and Quiz throughout course participation

WHAT IS THE COURSE METHODOLOGY?

The course is structured into knowledge-based presentations, 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

About the Speaker

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 experiences 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 master's 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's 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.