Medical Devices literally play a vital role in society. As they are key for healing patients and saving lives, they are subject to ever-increasing standards. That’s why QbD offers a wide range of quality management solutions to ensure their quality, safety and efficacy. However, the very definition of ‘Medical Devices’ is actually broader than it may seem, and mainly depends on the countless ways they can be applied in various medical contexts. Let’s take a closer look at what can be called ‘Medical Devices’.
The overall definition of Medical Device is ‘any instrument, apparatus, implement, machine, appliance, implant, reagent for in-vitro use, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination, for human beings, for one or more (…) specific medical purpose(s) (…)’.
These ‘medical purposes’ can be manifold – from the diagnosis to the treatment of a disease or injury, to the replacement or support of physiological processes. However, Medical Devices can also support or sustain lives, ensure conception control and even disinfect other Medical Devices. Furthermore, tools that provide information by means of in-vitro examination are also considered to be Medical Devices.
The definition of Medical Devices can also have a national dimension. For instance, disinfection substances and aids for persons with disabilities are considered as Medical Devices in some countries – but not in all.
Medical Devices for countless applications
Medical Devices are used in a wide range of applications – from surgical lasers, wheelchairs and sutures, to pacemakers, vascular grafts, intraocular lenses, and orthopedic pins. However, they also include diagnostic products, like in-vitro diagnostic reagents and test kits such as pregnancy test kits, and imaging systems such as Magnetic Resonance Imaging (MRI).
Moreover, Medical Devices are also found in so-called ‘combination products’. Take a prefilled pen with medicines: that pen is also considered as a Medical Device. And of course, Medical Devices are also applied as accessories to other devices.
Software as a Medical Device
In our digital world, we now also have Software as a Medical Device – which ranges from software that allows a smartphone to view images obtained from an MRI for diagnostic purposes, to Computer-Aided Detection (CAD) software that performs image post-processing to help detect breast cancer.
However, many more applications are thinkable for Software as a Medical Device, such as:
- Interfacing with hardware Medical Devices, other Software as a Medical Device, and ‘general-purpose’ software. Furthermore, there is also software that provides parameters that become the input for a different hardware Medical Device or other Software as a Medical Device. For example, treatment planning software that supplies information used in a linear accelerator is considered as Software as a Medical Device.
- Software with a medical purpose that operates on a general-purpose computing platform. This way, a computing platform that initially did not have a medical purpose, is now considered Software as a Medical Device. For example, software that is intended for diagnosis of a condition using the tri-axial accelerometer and that operates on the embedded processor on a consumer digital camera, is considered Software as a Medical Device.
- Software that is connected to a hardware Medical Device, but is not needed by that hardware Medical Device to achieve its intended medical purpose, is Software as a Medical Device and not an accessory to the hardware Medical Device.
- Software as a Medical Device can run on general purpose (non-medical) computing platforms. By running on these general computing platforms, it could be located in a hardware medical device.
Eager to find out more on this topic?
Read our page on the Medical Device Lifecycle, or check out QbD’s blog article on challenges and opportunities in the world of Medical Devices.