Why Quality Assurance is essential within Medical Devices

When it comes to medical devices, quality control assurance is of the utmost importance. According to McKinsey & Company, within medical devices, the cost of quality is $36 million a year, which equates to between 6.8%-9.4% of industry sales. An absence of quality control could have catastrophic results on a company’s reputation, income, and output.

So what does a breach in quality mean for companies?

  • Loss of income

Regulating bodies such as MHRA or FDA operate across the globe to ensure that medical devices are safe and fit for purpose. Not only can companies face heavy fines if a fault is found, but in serious cases manufacturing will be instantly halted, meaning they could lose a substantial amount of income on production loss. The business won’t be able to continue the production until the issue has been rectified, meaning all business essentially stops until an issue is resolved.   

  • Loss of reputation

It goes without saying that a quality breach could have a drastic impact on the reputation of a business. If a fault within medical devices is highly publicised across the media, it’s easily accessible for customers, meaning the company could suffer a huge backlash from consumers. Furthermore, it could be difficult to find high quality candidates who want to engage with a business whose reputation has been tarnished; the reaction could be damaging on numerous levels – companies could lose out on both talent and consumer loyalty. This could pose further problems when companies try to solve the problem.

  • Costs of cure

Prevention is better than cure; if a business hasn’t invested in sufficient QA professionals from the outset, they leave themselves open to significant risk. And the resources needed to clean up a problem could be significant. Bringing people in to fix QA problems is a costly, but necessary activity. However, it’s one that can easily be avoided if the right people are introduced from the initial stages of the product lifecycle. Nathan Puxty, Senior Principal Recruitment Consultant at Real, expands on this, “Ensuring medical device quality is critical to the safety of patients, but it’s also important for investors - otherwise they could see themselves having to fund a very expensive remediation project in order to fix major issues”

Whatever stage of the product lifecycle you’re at, and whatever your unique situation is, Real are here for you. At Real, we can give you access to a range of Quality Assurance professionals looking for a variety of permanent and contract jobs. If you’re looking for the right QA professionals to assist in your QA effort, get in touch with our dedicated team, today.

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