Remediation of risk management files according to (EU) 2017/745 and ISO 14791

New and already approved medical devices on the EU market will be subject to the new EU regulation on medical devices ((EU) 2017/745 -MDR) from 26 May 2020. The customer aims to renew the product approval and registration of its medical devices in the areas of medical vacuum technology and obstetrics in accordance with (EU) 2017/745. Structure, content and scope of the existing risk management files do not comply with the current regulatory requirements of (EU) 2017/745 and ISO 14791. PTA supports the customer in remediating and coordinating the risk management files in accordance with regulatory requirements, generating them audit-proof and storing them in the customer-specific quality management system.