Virtual Training: Risk Management for Medical Devices

(EN) ISO 14971:2019

(EN) ISO 14971:2019

About the Virtual Training

ISO 14971 is an ISO standard for the application of risk management to medical devices. This standard establishes the requirements for risk management to determine the safety of a medical device by the manufacturer during the product life cycle. Such activity is required by higher level regulation.

EN ISO 14971:2012 has been harmonized with respect to the three European Directives associated with medical devices (Medical Devices, In-vitro Diagnostic Devices and Active Implantable Devices) through the three ‘Zed’ Annexes (ZA, ZB & ZC). This allows the standard to be aligned with the directives and provide a strong framework for the analysis of risks associated to patients, environment, users and equipment.

This 2 day 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.

Scheduled on

Day: Thursday - Friday
Date: 19 - 20 August 2021
Time: 9.00 - 16.00 hrs.
Duration: 2 days
Speakers: TÜV SÜD’s Expert, Khun Parawee Dolsook - Senior Auditor Medical Health Service 
Language: Thai
Venue: Online via Microsoft Team

Training Fee: THB 5,000
Special Fee: THB 4,500 (Applicable for TÜV SÜD Thailand’s ISO 13485 Certification Customer.)
*Prices above are exclusive of 7% VAT.

 

 

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