Regulatory Affairs for Medical Devices Specialist (Level 1)
Issued by
Greenlight Guru
This earner is now a RA Specialist through Greenlight Guru Academy and has an understanding of core concepts that pertain to managing regulations for medical devices. The courses this individual completed while earning this badge establish a foundational knowledge of Regulatory excellence within the medical device industry.
- Type Learning
- Level Foundational
- Time Days
- Cost Paid
Skills
Earning Criteria
Standards
ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.
This document specifies terminology, principles and a process for risk management of medical devices, including software as a medical device and in vitro diagnostic medical devices.
The EU MDR entered into application on 26 May 2021. If you are a manufacturer, authorized representative, importer, or distributor of medical devices in the EU, or a regulatory affairs or quality management professional involved with medical devices, you need to know how to comply.
Current good manufacturing practice (CGMP) requirements are set forth in this quality system regulation. The requirements in this part govern the methods used in, and the facilities and controls used for, the design, manufacture, packaging, labeling, storage, installation, and servicing of all finished devices intended for human use.