1. E.U.Medical Device Directive (MDD) 

MDD is theMedical Device Directive for medical devices sold in the European marketplace,replaced in 2017 by the medical device regulation (MDR. This directive was created to harmonize laws regarding medical devices that are sold in the European Union.   

2. E.U.Medical Device Regulation (EU MDR) 

EU MDR is acommon abbreviation for the medical device Regulation (E.U.) 2017/745, which mandates the quality and safety requirements for medical devices produced and marketed in the European Union (E.U.). The E.U. medical device regulation replaces the MDDs that existed up to 2017. It emphasizes a complete product lifecycle approach.   

3. European Database on Medical Devices, (EUDAMED) 

The European Database on Medical Devices, or EUDAMED, was developed by the European Commission to facilitate compliance with European medical device regulations. It is intended to be a multipurpose system that allows registration, collaboration, communication, and communication between multiple stake holders in the medical device industry.   

4. Food and Drug Administration (FDA) 

The Food and Drug Administration, or FDA, is a federal agency of the U.S. Department of Health and Human Services. The FDA is responsible for approving medical devices for manufacture and distribution within the U.S. Medical device manufacturers operating within the U.S. market are subject to FDA inspections and compliance with the requirements outlined in Title 21 of the Code of Regulations. To know more about FDA Registraion visit - https://www.meddevicecorp.com/fda-registration/

5. Failure Modes and Effects Analysis (FMEA) 

FMEA(Failure Modes and Effects Analysis) is a way to find failures in design orprocesses associated with medical devices. FMEA is distinct from ISO 14971, the international standard for medical device risk management. FMEA can be divided into PFMEA (for processes) and DFMEA (for designs).   

6. Fault Tree Analysis (FTA)

Fault Tree Analysis, or FTA, is an analytical method to identify points of failureand risk within a quality system. FTA can be used in medical device manufacturing to identify potential sources of risk.       

( Related Article - Top 20 Medical Device Acronyms & Terminologies You Need to Know )