All Seminar & Event

Key takeaways of this virtual training:
  • Learn why are we moving from a directive to a regulation, including understanding the background to the changes.
  • Understand what the new regulation is trying to achieve. Its key objectives and purpose.
  • Able to identify what the important changes are and their relevance to you as a manufacturer.
Join our Virtual Training to hear from our expert on how to implement ISO 14971 and the Key Performance Indicators for risk management for medical devices through best practices sharing & project showcases with our experience in implementing and compliance-checking according to ISO 14971.
Scheduled on:
Day: Thursday - Friday
Date: 19th - 20th August 2021
Time: 9.00 - 16.00 hrs.
Duration: 2 days
Venue: Live online training via Microsoft Teams
Fee: *Exclusive of 7% vat.
THB 5,000*.- for Regular attendant
THB 4,500*.- for ISO 13485 Certification Customer of TÜV SÜD Thailand
Payment: prepaid
Speaker: TÜV SÜD’s Expert, K. Parawee Dolsook, Senior Auditor Medical Health Service
Language: Thai
Points to be covered
  • 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
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