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Medical device companies face stringent regulatory requirements, and for very good reason. After all, the safety and well-being of patients hangs in the balance. A medical device quality management system (QMS) provides a structured framework and toolset for improving the quality of both medical devices and related services, ensuring that they consistently meet customer requirements and regulatory compliance standards.

Regulatory agencies in nearly every major market require the implementation and maintenance of a quality management system as a condition of product registration. European device manufacturers tend to follow the ISO 13485 standard, while US companies must comply with the US Food and Drug Administration’s Quality System Regulation (QSR).

Nowadays, many manufacturers have switched from traditional paper-based QMS systems to automated medical device quality management software solutions with robust document control capabilities. Such software automatically collects data, routes documents for review and approval processes of various documents, and stores them in a single storage location.

What’s the best approach to selecting a QMS for your medical device business? This article will outline the key features and characteristics to look for. But first, let’s explore the benefits of a good QMS system a bit further.

Benefits of QMS in the Medical Devices Industry

As noted, regulatory agencies insist that companies producing registered devices must have a QMS system in place. Even without that requirement, though, there are plenty of good reasons to implement quality management software at your medical device company.

These include:

  • Reduced time-to-market, accelerating revenue, leapfrogging the competition, reducing risk, and increasing overall company valuation.
  • Deep root cause analysis, enabling product management, engineering, and production teams to collaborate effectively to identify problems and resolve them quickly.
  • Adaptability in compliance with industry regulations, enabling companies to respond quickly to a rapidly changing environment.
  • Elimination of wasteful activities through more efficient processes, automation of data flows, and mobile applications that do away with the need for paper-based systems.
  • Improved supplier relations and management, with documented processes, clear communication, and collaboration tools that enable the smooth flow of information with external trading partners.

There are numerous other benefits as well, including smoother audit processes, higher rates of customer satisfaction, reduced litigation risk, lower defect rates, and reduced scrap. Simply put, the best QMS for medical devices will help your business operate more efficiently and effectively.

What Features Should a QMS for Medical Devices Include?

An effective QMS for the medical device industry should include document control, training management, audit management, and CAPA management.

  • Document management includes the protocols and procedures necessary to manage the flow of critical information within your organization, amongst sponsors, investors, and the regulatory agencies throughout the lifecycle of your product.
  • Training management helps you document your company’s compliance with international regulations and standards such as the FDA’s 21 CFR 820 and ISO 13485:2016. These guidelines require medical device companies to use employees trained with specific skills for certain jobs. Training procedures must be constantly evaluated, and all employee training records must be properly maintained.
  •  Audit management makes it easier to comply with both the FDA’s 21 CFR 820 and ISO 13485:2016, which require medical device manufacturers to establish proper audit processes and to conduct regular quality audits, ensuring conformance to defined quality standards.
  • CAPA management provides a framework for implementing corrective actions and preventive actions (CAPAs) in compliance with international regulations such as the FDA’s 21 CFR 820 and the EU’s ISO 13485:2016. CAPA management helps manufacturers of medical devices to rectify any deviations or non-conformances that are likely to impact the quality of their products.
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Key Characteristics of a Great QMS for Medical Devices

A lot of vendors offer QMS software, – but how can you find the one solution that delivers the unique mix of features that make it ideal for your business? Here are some key characteristics to look for as you’re exploring a QMS product for your company:

Flexibility and Adaptability

A lot of QMS systems are prescriptive by nature. In other words, they box you into doing things the way someone else thinks they should be done. Your existing business processes might not necessarily fit well with the new software. If a QMS system is too rigid to conform to your unique needs, it can become a constraint, limiting the way your team operates. Instead of having the flexibility to configure the software to serve the way you work, you might be stuck following someone else’s rules and processes.

Customizable forms, for example, save time and eliminate the need for users to scroll through the fields and features they don’t use, just to get to the ones they need. If your QMS doesn’t offer flexible reporting templates, users are left to create the reports they need from scratch. If it doesn’t allow users to easily build custom forms and lists, they’ll end up using workarounds that eat up valuable time and money. Flexible, adaptable software is highly configurable, without requiring specialized technical expertise.

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Simplicity and Ease of Use

With some QMS systems, flexibility comes at a cost. If changes to your system require custom programming or specialized technical expertise, you could end up spending a lot of money to get what you truly need. Highly configurable software, in contrast, enables non-technical users to design workflows, custom screens, and reports – all without having a technical expert on hand.

Within hours or days of deploying the system, a quality management leader should be able to design their own functionality within the system, without any custom programming. At Intellect, we call that extreme configurability.

Anytime/Anywhere Access

Cloud-based software has become the industry standard for a number of reasons. It’s more secure than on-premise systems because it benefits from 24x7 monitoring by cyber security experts. It’s simple to deploy, with no need to install client software on every computer in your company. Perhaps most Importantly, though, cloud-based software offers anytime/anywhere access.

During the COVID pandemic, remote work suddenly became a necessity. A good cloud-based QMS meant that quality managers, auditors, and executives could all access the same system, in real-time, without coming into the office.

Mobile applications, likewise, offer a way for users to look up information, record nonconformances, and perform other common functions directly from the shop floor, without returning to a workstation or laptop. That speeds the flow of information and makes your entire team more efficient.

If you’re looking for a QMS for medical devices, Intellect would love to talk with you. We have deep experience with FDA-regulated industries, including medical devices and pharmaceuticals. Contact our team to discuss your goals and to find out if Intellect is the right fit for you.

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Tejas Puranik

Written by Tejas Puranik