Why is the ISO 13485 Standard for Medical Devices So Important for Companies?

The medical device manufacturing industry is a rapidly growing business sector around the world. With the combination of science and technology together they have revolutionized the medical world as it has helped to augment the recovery process. Medical devices are therefore an indispensable part of medical services across the globe. With companies coming up with affordable and effective devices every day, the market is competitive. Getting an ISO certification is the best way to strategically strengthen your competitive advantage.

The widely pursued global certification is the ISO 13485 standard for medical devices. From small to large-size manufacturers and sellers of medical machinery, everyone wants to obtain certification to maintain the quality of service/products and delivery. Especially, for small and medium-sized medical device production companies, accreditation becomes important ascompetition among small businesses is higher. Companies with these certificationscan earn a better reputation in the international market, which gradually affects their profit margin.

What is the ISO 13485 standard and what is its purpose?

The standard is designed to control the quality of production and delivery of medical devices. ISO 13485 has been derived from the international series for quality management. The standard acts as a process-based model, which enables manufacturers to maintain the quality benchmark and meet market demands. The purpose of the certification lies in its clauses. The requirements of the standard imply that the certification is made for increasing enthusiasm to maintain quality, stakeholder engagement, a sense of accountability, and customer satisfaction. Every manufacturing company is expected to deliver products, which are free of defects and malfunctions. Especially, the medical device manufacturing industry which is responsible for the fast recovery of countless patients. The standard ensures that a company understands the importance of quality assurance and enforces a sustainable and effective control system. The following benefits will help to understand the reason behind its importance and popularity among various companies.

The benefits of implementing the ISO 13485 standard for medical devices

  • Increase credibility and identity

With this standard in place, a company is forced to provide devices that perform as expected. The certification enables companies to avoid any disruptions that impose a compromise on the quality aspect. A company gets to maintain a particular benchmark, which helps it to earn a strong presence in the market. Their credibility increases as the company understands how to comply with international standards. Moreover, the standard allows companies to stay updated about customer needs and ongoing market trends. Therefore, they keep adding necessary modifications to the service. 

  • Increase employee engagement

A company cannot achieve long-term success if it fails to engage its employees in the system. One of the main requirements of the ISO 13485 standard is stakeholder engagement. According to that clause, a company is obligated to increase the morale of its human resource by showing them how valuable they are. Engaging them in the decision-making process or risk aversion programs should be set into place to increase their proactiveness.

  • Increase customer satisfaction

It is not hard to understand that by maintaining quality performance, a company successfully earns customer satisfaction. By meeting their demands and desires regularly, they build a strong brand image, which increases customer loyalty. It further affects the profit margin and international acknowledgment. A company not only achieves the existing customers’ constant support but also acquires new customers as the existing client base works as strong references.

  • Promotes continual improvement

The most important principle of the framework designed by the ISO 13485 is continual development. A company learns the importance of correction and constantly upgrades devices and tools based on demands and innovations. The management team gets manual data on the improvement needs, which helps them to systematically eliminate problems via audits and reviews.

  • Increase the decision-making power

Evidence-based decision-making is one of the key aspects of the quality management system mandated by the ISO 13485. It helps management to take decisions with the help of real-time data that properly align with the strategic goals of the company. It is evident that companies are concerned about their customers’ expectations as it determines their longevity in the market. The ISO 13485 standard for medical devices, therefore, is getting more important. It is better to get certified with the help of professional ISO advisors than to fill up templates online.

ComplianceHelp Consulting LLC is the most trusted consultancy service provider that helps to achieve certifications in the most convenient and fast way. Their professionals have industry experience and market knowledge to provide you with personalized solution models.