The term, medical device, encompasses multiple products used by a variety of medical specialties and covers a very wide population and with specific needs. Medical devices can come in different shapes, sizes, and functions – from as simple as a tongue depressor to as complicated as a heart pacemaker. The ISO 14971:2019 defines a medical device as any instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material, or other similar articles that is intended for use by human beings only.
“Risk Management strategies for Medical Devices: An Inter-agency and multi-regional analysis” -Renan James Lim, Oliver Alix and Venus Marie Rojas
Posted by