(EN) ISO 14971:2019
(EN) ISO 14971:2019
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.
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.