Considering the effect that medical devices have on people’s lives, it’s not surprising that they are subject to strict technical and legal requirements. This is where ISO 13485 can help. It contains best practices for medical device manufacturing, and compliance is essential for anyone making tools and appliances in the industry. It also ensures organizations that supply medical devices satisfy the legal requirements that apply in multiple jurisdictions.
The World Health Organization estimates that there are an estimated 2 million different medical devices currently available on the global market, and their manufacturers have all had to pass a number of regulations and requirements, such as ISO 13485.
What Is ISO 13485 Certification?
ISO 13485 is part of the ISO 9000 family of standards, which contains best practices for implementing a quality management system (QMS). Whereas ISO 9000 is industry-neutral, ISO 13485 contains specific requirements for manufacturing medical devices.
The framework helps organizations develop a consistent, repeatable process for designing, developing, producing, installing, delivering, and disposing of these products.
It’s one of a handful of ISO standards for medical devices. Although compliance isn’t in itself a legal requirement, ISO 13485 provides a framework that helps organizations adhere to medical device directives, regulations, protocols, and responsibilities.
ISO 13485 Benefits
Achieving ISO 13485 compliance isn’t only about meeting legal requirements. There are also several other direct benefits for your organization.
Create a Culture of Continuous Improvement
One of the core principles of quality management is continuous improvement. It isn’t enough to make a single change and record a small improvement. Instead, you must build on these upgrades to create large-scale, positive change.
Implementing a QMS in any organization, regardless of its size, creates a cultural shift. All areas of the business should be looking for ways to operate more effectively, and if you reward employees for suggesting improvements, you can create a dynamic work environment.
More Evidence-Based Decision Making
Continuous improvement can only happen if you assess your current practices to look for opportunities for improvement. Analyzing relevant data can highlight ongoing issues that should be addressed.
Enhancing Product Quality and Safety
With a QMS in place, your organization can produce reliable medical devices without the risk of product recalls or lawsuits. Given ISO 13485’s core principle of continuous improvement and the increased employee engagement that comes with it, you will be in a better position to improve product quality and safety.
Meet Government Regulations
Manufacturers of medical devices in the U.S. are subject to several government regulations. The Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) oversees medical device regulation, with support from the Center for Biologics Evaluation and Research (CBER).
By meeting these regulations, you’ll protect your organization from lawsuits and fines, as well as the reputational risks that come with it.
Reducing Operational Risks
A QMS requires organizations to perform regular assessments of their practices. Under ISO 13485, this includes an evaluation of the complete manufacturing process, from design to disposal. This process can identify and mitigate operational risks, which in turn will reduce mistakes and product recalls.
Avoid Lawsuits From Patients
The Federal Drug Administration estimates that defective medical devices result in 200,000 injuries per year. If a device causes injury to the user and is proven to be faulty, the patient could sue the manufacturer.
But if you can show compliance with ISO 13485, you can prove that you met your requirements when manufacturing the product. Not only is the possibility of an injury far less likely, but you will also reduce your liability should an accident occur.
Improve Patient Outcomes
High-quality medical devices can help patients receive accurate diagnoses and improve their overall quality of life. If the devices you produce have a documented track record of positive patient outcomes, it will improve customer satisfaction and could provide a competitive advantage.
Boosting Customer Confidence and Credibility
ISO 13485 is a globally recognized standard, and certification demonstrates that your organization is committed to providing high-quality products and services. It also proves that the medical devices you manufacture comply with relevant government legislation and industry requirements.
Organizations that achieve ISO 13485 certification often advertise their compliance status on their website and press materials to give customers and other stakeholders confidence in your practices.
ISO 13485 Certification Success With Orion Registrar
Find out how you can certify to ISO 13485 with Orion Registrar. Our expert auditors are on hand to help you complete the certification process.