The Importance of a Quality Management System (QMS) for Your Medical Device

May 28, 2024
Quality Management Systems QMS
Pär Neidenström

Pär Neidenström
Senior consultant, Medical Device QA


Dalia Rhman
Product manager PRRC, Medical Device QA

The purpose of this article is to highlight the crucial role of the quality management system (QMS) for medical devices. Mainly by maintaining and improving patient safety and the product quality of the medical devices that are manufactured today. Of course, a well-developed and efficient QMS also has a very large impact on the manufacturers’ compliance with the regulatory requirements, e.g., MDR 2017/745, ISO 13485 and 21 CFR 820.

Compliance to these regulations should ensure the safety and performance of the products. This article will furthermore explain why you as a manufacturer should consult experts regarding both quality and regulatory issues; areas where GBA Key2Compliance is the obvious choice when it comes to contributing and creating great value.

The critical role of a risk-based QMS in ensuring safety and compliance

Why should you have a well-functioning risk based QMS system? It is not an unimportant question to ask yourself. If you do not understand it, you will have problems with your regulatory compliance.

The short answer is that authorities have discovered serious defects in products and manufacturing processes. Such processes have resulted in sometimes serious patient injuries. Poor controls in production and routines, cheating and carelessness are the cause of these deficiencies. Which in turn has resulted in large increases in the requirements for the content of quality management systems over the years.

It is easy to forget that a medical device consists of the product itself and all the documentation that has been created during product development (the technical file) and the batch documentation that is created for each unit produced A product without a complete and accurate documentation cannot be placed on the market. A risk based QMS ensures an implemented product development as well as regulated production processes. More specifically: a technical file which meets all regulatory requirements; and that produced units are traceable, documented, controlled, and holds a high product quality.

Essential processes within your Quality Management System

A comprehensive QMS system is crucial for meeting regulatory compliance and ensuring the production of high-quality medical devices. Here are the key components that should be included in your QMS:

  • Product Development: Ensures that all products are designed with safety and efficacy in mind from the outset.
  • Risk Management: A systematic approach to identifying, evaluating, and mitigating risks associated with your products.
  • Production Control: Processes to ensure that every product is manufactured consistently to the highest standards.
  • Deviation Management: A system for handling any deviations from standard processes, including investigation and corrective actions.
  • Complaint Management: Procedures for receiving, reviewing, and addressing user complaints effectively.
  • Regulatory Processes: Including Post Market Surveillance, clinical evaluations, and biological evaluations, ensuring continuous compliance with industry standards.

Partnering with a knowledgeable and experienced firm like GBA Key2Compliance can assist in developing or enhancing these elements within your QMS. Their expertise ensures not only compliance but also the efficiency and effectiveness of your system, paving the way for regulatory success and high-quality product development.

Fostering a culture of continuous improvement

A QMS should preferably encourage a culture of continuous improvement. The important feedback from stakeholders e.g., patients, healthcare professionals and regulators, should be integrated into the system. This will help drive corrective and preventive actions (CAPAs), and process improvements. A standardised way of working is also a consequence of a well-functioning QMS.

Important key processes creating opportunities for improvement are: the CAPA process; the deviation process; the complaints process; management review; internal and external audits; Post Market Surveillance (PMS); and risk analyses. An important source of improvement opportunities is the after-market analyses of the products on the market.

Potential problems can be detected as long as the performance of devices on the market is well monitored. This leads to proactive actions could be taken to reduce risks and thereby improve the product. Effective production control systems ensures that the manufacturing processes are carried out according to production methods. All failed checks become deviations and thus good opportunities for improvement.

Integrating risk management into your Quality Management Strategy

The risk management process is a key process in a risk based QMS. An effective risk management process plays a crucial role in ensuring product safety, regulatory compliance, and overall quality improvement. By systematically identifying, assessing, and reducing risks associated with products or processes, organisations can improve product quality, patient safety and minimising the likelihood of side effects. Risk Management is an essential part of the various regulations and is described in the regulations ISO14971.

Effective risk management not only helps companies meet regulatory obligations but can also contribute to cost reductions. Mainly by discovering risks that could generate large costs due to potential product recalls, patient injuries, etc. In addition, risk management provides valuable insights that: support informed decision making; foster a culture of continuous improvement; and drive innovation within the organisation. Therefore, it is important to integrate risk management into the QMS to ensure long-term success and sustainability of life science organisations.

Overcoming the challenges of QMS implementation and optimization

Creating, improving, and implementing a QMS can feel complicated and resource intensive. However, companies don’t have to take on these challenges on their own during this important journey. GBA Key2Compliance offers full comprehensive support. We have compliance solutions tailored to the unique needs of medical device manufacturers and distributors. With our many experts, both senior and junior; extensive experience in regulatory regulations; quality management and clinical evaluations.

GBA Key2Compliance provides a well-equipped team to guide organisations through every step of QMS implementation, optimisation, and maintenance. We build your QMS from scratch and help you convert from QMS to eQMS. GBA Key2Compliance offers additional comprehensive support in product development which includes support in quality, regulatory, clinical evaluation, and biological evaluation.

Conclusion: the strategic advantage of a quality management system

In summary, quality management systems are a critical tool for achieving regulatory compliance, while maintaining and improving product quality within the medical technology industry. By adapting to regulatory requirements, a quality culture is promoted. Moreover, by utilising the expertise from GBA Key2Compliance, companies can more easily navigate the complex regulatory landscape. Like this, safety and quality of devices is being thoroughly ensured and can therefore be safely used by patients worldwide.

By partnering with GBA Key2Compliance, organisations gain access to a vast pool of competencies encompassing regulatory strategy development, risk management, design controls, and post-market surveillance. From creating a management system (QMS) to its implementation and documentation support to regulatory training and auditing services, GBA Key2Compliance offers a tool to ensure product compliance and market success.