What is a quality management system for medical devices?

As technology evolves, so too does our ability to keep track of all aspects of life – from our finances to our medical health. Wearable technologies even allow us to set targets for walking, running, or even quitting smoking. Of course, there remain many questions as to where this trend will go next too.

Technology has also made many other steps within healthcare practises considerably easier and more efficient; from keeping patient records to prescribing medicines. Where before, healthcare had been littered with avoidable mistakes, the tools we have at our disposal now help us massively in minimising those mistakes – perhaps even eliminating them entirely.

Many industries require some kind of structural framework, and in some cases, it isn’t necessarily a matter of life or death. In healthcare, however, it most certainly is, which is why it’s so crucial to have some kind of quality management system (QMS) in place.

With this in mind, it’s worth looking into what a QMS actually entails in general, then more specifically in the world of healthcare.

What is a QMS?

A quality management system is a structured system of procedures covering all aspects in numerous areas – from design, to risk management, to product labelling, and several other steps in between. The purpose is ultimately to improve quality and consistently meet expectations.

With all of this in mind, it serves as an integral part of medical devices, which must meet these justifiably stringent regulations. After all, we rely on technology to make our lives easier rather than needlessly complex. Furthermore, the healthcare industry is certainly an industry in which heavy regulation is something we deem a strict necessity given the risks involved.

Medical Device Management is crucial for a number of reasons and has countless benefits. For example, the eradication of valueless activities, as well as the minimisation of errors with deep root cause analysis. Technology is our friend if we use it correctly, and the fearmongering over ‘AI taking our jobs’ is wholly unnecessary. Technology is there for us to work with, not for it to work against us.

The medical industry is a testament to this, with a QMS providing adaptability throughout the process, which could be highly important in the event of industry regulations changing. It is worth noting that the quality management system requires document control, training management, audit management and CAPA management.

What steps are involved?

The first part of any medical device QMS is the design aspect, followed by production control. This second step also includes risk monitoring, which naturally is a key part of the entire process. This ties into the need for vigilance and optimum complaint handling, as any issue with the product needs to be addressed as soon as it’s flagged up.

Other areas involved include management responsibility, which ties in with the audit, as well as readiness and reviewing procedures. Then we get to corrective and preventative action, which also ties in with risk mitigation and monitoring. If change is needed, then that also needs to be managed as part of the QMS.

Though it may seem a painstaking process, it’s better to be safe than sorry to quote the old adage. Nowhere is this more the case than in the health and medicine industry, where one wrong move can be fatal.

Published by Kidal Delonix (1198 Posts)

Kidal Delonix is a contributor to Mr. Hoffman's blog. The views and opinions are entirely his/her own and may not reflect Mr Hoffman's views.

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