“Risk Management strategies for Medical Devices: An Inter-agency and multi-regional analysis” -Renan James Lim, Oliver Alix and Venus Marie Rojas

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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.

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