Quality Management Systems are Key to Develop Medical Devices

Using a quality management system (QMS) while developing medical devices can help guarantee the safety and quality of the final product. These systems also help organizations to deliver effective products to the market that, above all, put the patient at the center of healthcare. Also key to the successful development of medical devices are biomedical engineers, who contribute to the design of effective and safe products. 

“Technology must be safe and effective. We must reduce the damage technologies cause during a patient's healing process. Quality standards are essential to ensure this,” said Francisco Aceves, President, Mexican Society of Biomedical Engineering (SOMIB).

QMSs group a large number of processes and procedures covering all aspects of a medical device’s lifecycle to ensure its quality and functionality. But to be truly successful, these systems must guarantee operative continuity, ensure that innovation is safe and effective, optimize costs and ensure that the device is aligned with all certifications. “A QMS guarantees the optimal use of sanitary technologies,” explained Aceves.

These tools aim to reduce time to market for devices, helping them to comply with industry regulations while eradicating activities that do not add value and improving supplier relationships and management, according to Intellect. The ISO 13485 norm guarantees that all medical devices abide by industry standards during the implementation of a QMS. “Increasingly, organizations in the industry are expected to demonstrate their quality management processes and ensure best practice in everything they do,” says ISO.

The three stages of a QMS are: operative management, evaluation and selection, and regulation and development. The operative management stage is linked with a health technology assessment (HTA) to evaluate the potential benefits and efficiency, clinical and technical safety and the cost-effectiveness relationship. The evaluation and selection stage involves a health technology management (HTM) process, while the last stage involves a health technology regulation (HTR) process that can be supported by adhering to ISO, IEC norms and the official Mexican standards for operation and evaluation.

To implement a successful QMS, companies must ensure that they have the correct multidisciplinary teams that can help them to correctly develop new technologies. “Multidisciplinary teams are key to properly tackle sanitary technologies, but also help to adapt to different social contexts,” says Aceves. Although many players are needed for these teams to be successful, biomedical engineers are essential as they are experts in both the necessary technology and the available equipment. “Hospitals should have a biomedical engineering department to participate in equipment and regulatory framework evaluations,” he explained. Despite their relevance, biomedical engineers are sometimes not consulted by hospitals.  

Mexico’s General Law of Health classifies medical devices into six categories: medical equipment, prosthetics, orthotics and functional aids; diagnosis agents; dental use supplies; surgical and healing material; and hygiene products. Each of these groups has unique requirements that manufacturers must follow. The wide variety of requirements forces each QMS to adapt to the needs of each category. 

By consistently delivering high-quality medical devices, companies can increase their client base and gain a better reputation in the market. QMS offers the patient more safety, better health outcomes, more accessibility to medical devices and improved transparency. By adopting these technologies, the organization leaves room for expansion, growth and profit. If norms and standards are not applied within the processes, companies put the lives of people at risk and innovation can be lost.