Quality, safety, and compliance are huge factors in the healthcare sector. When you develop a new medical device, you must follow diverse guidelines and regulations. These standards ensure that your product serves its purpose throughout its life on the market. Quality certifications like ISO 13485 guarantee the safety and satisfaction of users. Adhering to these standards is essential to developing and manufacturing high-quality, effective medical devices. That’s why you should partner with development firms that have strived toward ISO 13485 certification. Learn the importance of working with an ISO 13485 certified company—and the benefits it brings to your business—with this guide.

What Is ISO 13485?

Before you can understand the impact of working with an ISO 13485 certified company, you should know more about the International Organization for Standardization and the guidelines they develop. ISO creates and publishes standards for quality across a vast range of industries, products, and processes. The ISO 13485 standards revolve around medical devices and the companies involved in designing, producing, installing, or servicing these products.

Sections 4 through 8 of ISO 13485 introduce five specific requirements of a quality management system for medical device development. Section 4 discusses the general requirements of a quality management system, including monitoring processes and determining necessary methods of quality management. Section 4 also discusses creating and publishing necessary files such as a quality manual, a medical device file for each project, and records that prove conformity to ISO standards.

Section 5 discusses management responsibility and the role top management personnel should play in the quality management system. This section also discusses the importance of customer focus and the need to meet customer requirements.

Section 6 covers resource management—including human resources, infrastructure, and the work environment. This section emphasizes that providing these resources is key to maintaining an effective quality management system.

Section 7, product realization, details requirements for all aspects of planning and developing a product. This includes designing, creating, and reviewing a product as well as controlling the equipment that monitors and measures said product.

Finally, Section 8 discusses measurement, analysis, and improvement of the quality management system. You can use methods such as customer assessments, internal auditing, and product monitoring to continuously revise and improve upon the quality management process.

The Importance of Working With an ISO 13485 Certified Company

What do these standards mean for you as a client? ISO 13485 defines the kind of standards and processes you should look for in a medical device development firm. These standards guarantee more than industry compliance. They indicate the kind of value you’ll receive when you work with a certified company. Here are just a few of the benefits you can look forward to you when you partner with an ISO 13485 certified company for diagnostic product development and other medical device services.

Guaranteed Credibility and Reputation

ISO standards are international indicators of incredible quality. Companies with an ISO 13485 certification have put time and effort into being the best they can possibly be. Working with a certified company means working with an entity that is passionate about the products and services it delivers. ISO certified companies take quality seriously, which means they’ll take your job seriously. Moreover, the international recognition that comes with ISO certifications creates reliable credibility and a good reputation for a company, which in turn creates more opportunities. An ISO 13485 certified company might have easier access to materials, equipment, and other resources necessary to complete your job correctly. A reputable quality management system opens doors for developers and, in turn, the clients who work with them.

Prioritizing Customer Needs

Customer satisfaction comes up multiple times within the ISO 13485 requirements. Companies that adhere to these standards prioritize their customers’ needs and requirements. By partnering with these companies, you know that you’ll be happy with the results of your project. ISO 13485 certified companies go above and beyond to deliver quality to their clients. Even better, they already have the practices and resources in place to turn your idea into a successful product.

Tried and Tested Processes

There’s a reason why ISO created a gold standard for quality across the world. The requirements and guidelines outlined in ISO 13485 are the work of multiple experts with years of experience and data on their side. A company that builds its quality management system without these standards only has its own experience on which to rely. Companies that adhere to ISO 13485, on the other hand, follow strategies set forth by years of hard work and evidence. Moreover, ISO 13485 defines a need for evidence-based changes and decisions. Companies that follow these guidelines use facts and data to drive their decisions. This creates more effective strategies and improvements for their quality management systems. When tried and tested practices define a company’s quality control, you reap the benefits of efficient, effective, and compliant processes.

Endless Improvement

As mentioned above, ISO 13485 contains a section that revolves around analyzing and improving the quality management system. Companies who follow these standards when building their quality control processes will also strive to follow this last standard. Continual improvement helps a company deliver better results with every project they take on. Who would you rather work with: a company that thinks acceptable products are good enough, or a company that consistently strives to go above and beyond expectations? ISO 13485 certified companies incorporate continual improvement into every step of the process. With ongoing analysis and assessment, these companies can review their current processes and identify ways to reduce errors and minimize the consequences of problems. The result is a development process that gets better with every project. This puts the certified company’s work—and your product—above what other competitors in the market could achieve.

World-Class Quality With Every Project

ISO 13485 certification is a high achievement. Companies that adhere to these standards know their industry well and perform their job with the utmost passion and care. When you work with such a company, you see results that reflect that quality. ISO 13485 standards establish practices that deliver nothing but success. Working with these companies means designing medical products that are safe, effective, and valuable for both you and your users.