Jon Speer, founder and VP of QA/RA at Greenlight Guru offers his thoughts on developing strong quality control and assurance culture in the medical device industry.
Change has always developed at a rapid pace in the medical device industry. These changes compounded with new challenges brought forth by COVID-19 can leave industry leaders feeling uncertain about how to innovate and ramp up production to meet soaring demand, all the while ensuring quality remains a core focus.
To navigate the rapidly evolving landscape, medical device companies must prioritise quality and the culture that surrounds it by conducting practical training, utilising the best medical device quality management system (MDQMS), and seeking out the right strategic partners. Let’s take a closer look at how you can find success in these three areas, particularly as it pertains to quality assurance and quality control of your medical device.
Create a True Quality culture amongst your team
Proper training of employees is an essential investment, as this will pay dividends throughout a company’s existence. The best teams are trained through methods that reinforce a company’s quality culture and values in order to further establish quality as a strategic asset for their business. A critical aspect of training medical device professionals is placing an emphasis on the key differences between quality assurance and quality control.
Quality assurance is a process-driven function that ensures ongoing maintenance and preservation of a quality product. Quality control focusses on the standards by which the quality of a product is measured and whether the outputs meet specifications.
Adopting an industry-specific MDQMS, rather than paper-based or general-purpose quality systems, is the most efficient way to manage the quality of a medical device.
Equip teams with the best quality tools
If a restaurant doesn’t receive any health code violations, does that mean they are making great food? Not necessarily, and it also doesn’t guarantee they will be in business tomorrow. The medical device industry works in quite the same way. If a manufacturer doesn’t have any noncompliance violations, this doesn’t mean its device is a quality product.
Many medical device companies struggle to keep quality a focus because managing their current quality system is already too painful and challenging of a process, limiting their focus to compliance-only. General-purpose and paper-based systems are not scalable solutions and do not have the capabilities to execute necessary tasks, collect signatures, and achieve closed-loop traceability in an easy and efficient way.
The Greenlight Guru platform manages every process that occurs throughout the product lifecycle with workflows that follow industry best practices. Users of the MDQMS software benefit from end-to-end traceability by integrating pre- and post-market processes, like CAPA management, design controls, and risk management activities every step of the way.
The benefits of an MDQMS amount to streamlined processes that enable access to reliable data, accelerate device clearance timelines, reduce risk, facilitate real-time audit readiness, and promote the culture of quality necessary to be a top performer in the industry.
Work with the right strategic alliance
While compliance cannot replace quality, it’s essential to build a strategic network of people you trust who can help you accomplish both. This is why we formed a strategic alliance with Emergo by UL to deliver an all-in-one quality management and regulatory affairs solution to medical device companies.
Our alliance is one example of how a trusted network can enable success; together we help medical device manufacturers bring devices to market faster and ensure quality and compliance in today’s constantly changing landscape.
True Quality is a company-wide effort and should be prioritised in every stage of the medical device lifecycle. Your devices can change patients' lives and make a difference, which is why companies must build a culture focused on quality and provide employees with best-in-class tools that enable them to produce quality products. By implementing proper training, utilising industry-specific tools, and building the right strategic network, your business can find success and continue to set the bar high for innovation and True Quality.
