Within a highly standardized industry, such as the medical device software one, implementing a Quality Management System is now more crucial than ever. It is actually a must-have to comply with the ISO 13485, Medical Devices – Quality Management Systems – Requirements for Regulatory Purposes. But how to get started with it concretely ? How to choose a QMS software ensuring a fast, effective implementation ? To deal with it, let’s go through Gartner experts’ advices and then let’s see what it means for the medical devices manufacturing.

Quality challenges and opportunities in the MedTech

A more and more regulated medical environment

Within an already highly standardized industry, such as the healthcare one, the medical device sector is at the very heart of a really peculiar context: not only is it subject to more and more standards constraining the practices and processes adopted by the different organizations involved in a Medical Device software lifecycle (i.e. the requirements of the IEC 62304 standard for Medical Device software), but competition is rapidly intensifying too, bringing a wide range of products to market.

To deal with this changing environment, it is crucial to comply with the standards as to keep on delivering products ensuring the highest quality in terms of performance, security and hence reliability. In other words, the organizations operating within this industry have to implement a Quality Management System (QMS) aiming to better coordinate and monitor all their activities and processes to meet the requirements of both standards and customers’ demands.

A transition as an opportunity for improvement

Why is the Quality Management System (QMS) the backbone of the medical device manufacturing? Because Quality Assurance people are involved from the very beginning of the product development cycle to mitigate risk and spread over teams the quality best practices. These latest months, the dynamic medical trends have taken a major leap : digital transformation makes software technology the driver of innovation. Medical devices are more complex to develop, with more and more embedded software. In the meanwhile, medical device regulation (MDR) entered into force with reinforced supervision and control of medical devices.
This is both a challenge and an opportunity : a transition step as the opportunity for quality policies upgrade and a larger deployment of good practices across teams.

Choosing a QMS software to achieve MedTech compliance

A good Quality Management System is actually a must-have to be compliant with the standard “ISO 13485 Medical Devices – Quality Management Systems – Requirements for regulatory purposes“. However, note that it does not translate into the application of a strict, standardized framework or process for any enterprise. In fact, each organization of the medical device industry has to formalize its own quality management system, depending on its structure, its activities, and most importantly, its management approach; and this because the QMS is there to help organizations achieve their goals in terms of standards compliance and market requirements satisfaction.

Ultimately, if you are in charge of defining a quality management system you definitely know it: it is way more a mindset based on continuous improvement at all levels, rather than the mere setting up of a “new” process. Your responsibility is therefore critical since on the one hand you will have to set goals, plan actions and define methods to prove and ensure standards compliance, while on the other hand encouraging teams and leading cross-functional actions to finally improve productivity and overall performance.

When implementing your Quality Management System, it is essential to rely on a flexible, easy-to-customize solution to succeed in harmonizing your processes, tools, and teams accordingly to your business challenges and needs. Now coming further into this subject with recommendations from Gartner.

Insights from Gartner® to choose the right QMS software

According to the research “Market Guide for Quality Management System Software” released in January 2022 by Gartner® – a company that delivers actionable, objective insight to executive and their teams – and written by the analyst Samuel New:

“As organizations plot their emergence from COVID-19 disruptions, they face a number of new challenges including permanent shifts to remote/hybrid working, disruptive global supply crunches, and changes in demand and customer profiles. However, astute observers recognize that the fundamentals of quality management remain not only intact, but also more important than ever before. The often-repeated but also seldom-followed notion that “quality is everyone’s job” is now being realized at un unprecedented scale, further underscoring the need for advanced and modern QMS solutions across all business units, geographies and product families. Just as quality management varies widely across industries, companies, business units, product lines, geographies and regulatory environnements, so do requirements for QMS workflows and functionality.

In addition to the traditional focus on core QMS capabilities, buyer organizations and end users now demand an unprecedented level of flexibility, adaptability and ease of configuration. […] These changes have underscored the deficiencies in organizations that have maintained their homegrown systems, tailored approaches to quality management and paper-based record keeping. […] As such, organizations continue to recognize that custom-made approaches to quality management and homegrown systems are insufficient, increasing the likelihood of exposure to quality incidents and regulatory noncompliance. Other organizations that do not have any QMS solution in place find themselves even further exposed. Many of these organizations still rely on spreadsheets and the like, for which there is no governing process or central repository. Historically, cost avoidance and change resistance have impaired adoption of commercially available solutions. However, today paper-based and spreadsheet based approaches are increasingly viewed as fundamentally insufficient and sources of risk, and often seen as an obsolete even by those who use them.”

As to formalizing processes, Gartner® supports and guides organizations in the choice of their software tool to ensure the implementation of an efficient QMS. Here follows an extract from the research to provide you with some of the buyers’ main criteria when choosing an efficient software for their quality management system:

– Promote organizational resilience and risk-sensing through analytical tools and novel technologies,
– Ensure, encourage and enforce compliance,
– Offer desired functionality coupled with the ability to adapt to changing circumstances,
– Have a user interface/experience (UI/UX) that will support rather than hinder user adoption, particularly for casual or infrequent system users,
– Promote transparency across the organization,
– Can be licensed and hosted in specific ways,
– Incorporate new technologies (including IA, machine learning [ML] and IoT) in a meaningful, accessible way without compromising quality core management functionalities,
– Offer workflows for both in person and virtual quality audits.

Extracts from Gartner® report “Market Guide for Quality Management System Software”, published on January 2022

How, we believe, Tuleap meets the criteria

1️⃣ Have a user interface/experience (UI/UX) that will support rather than hinder user adoption➡️ Ready-to-use templates to simplify and drive user adoption when starting new medical devices software projects
2️⃣ Promote transparency across the organization➡️ A collaborative platform ensuring 100% transparency and real-time project monitoring: information is gathered in one single place and shared with all the involved stakeholders
3️⃣ Offer desired functionality coupled with the ability to adapt to changing circumstances➡️ A wide range of agile tools that allow organizations and their teams transition to a more iterative and incremental way of working, while being able to adapt the tools to their specific needs and processes
4️⃣ Incorporate new technologies in a meaningful, accessible way without compromising core quality management functionalities➡️ The implementation of a standardized process to meet the medical industry’s requirements and the possibility to integrate the software across other tools to benefit from an centralized all-in-one solution (efficiency, quality, reliability…)
5️⃣ Ensure, encourage and enforce compliance➡️ Enables automated end-to-end traceability overall the medical device development: process design, configuration and requirement management, risk management and the relates risk mitigation measures, test and validation campaign planning to ensure and prove standards compliance (i.e. ISO, IEC, ASPICE, IATF….)
6️⃣ Offer workflows for both in person and virtual quality audits➡️ Provides project workspaces that auditors can easily access, even remotely, and enhances a greater capacity to prove compliance thanks to the automatic generation of a traceability matrix that prove you meet both customers’ expectations and delivered products quality standards
7️⃣ Can be licensed and hosted in specific ways➡️ Offers several on-premises and in the cloud hosting solutions as to best adapt to the organization’s needs and support software deployment
8️⃣ Promote organization resilience and risk-sensing through analytical tools and novel technologies➡️ An enterprise agile planning tool enhancing adaptation capability to a fast-paced environment that englobes features and tools to help organizations manage requirements, assess and tackle risks – this, through a data-driven approach thanks to the customizable dashboards and metrics available within the software tool – as well as reinforce test management to keep ensuring durability and quality


How to develop medical device software compliant with ISO 13485 and IEC 62304 standards? 

Article based on Gartner, Market Guide for Quality Management System Software, By Sam New, 4 January 2022.
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