How ISO 13485 Certification Enhances the Safety and ROI of Biomedical Equipment

Doctor encouraging a patient in bed

Clinical asset purchasers have so many serious factors to consider when making decisions about lifesaving biomedical equipment. And the cost of purchasing a new medical device, such as an infusion pump or telemetry monitor, is certainly no joke. According to 2021 market research, infusion pumps made by leading original equipment manufacturers (OEMs) currently range from $2,380 to $5,982.

Repairing lifesaving medical equipment can significantly increase device lifespan and, therefore, ROI--but only if the repair restores OEM-level safety and functionality. Using 3rd-party replacement parts helps lower repair costs while avoiding common OEM issues like limited availability, delayed shipping, and discontinued components. However, the FDA ensures that OEM parts will always meet regulatory quality standards. Unfortunately, that's not true for all 3rd-party products on the market. Surprisingly, 3rd-party medical device manufacturers aren’t required to follow 21 CFR 820, Quality System Regulations.

That leaves decision-makers tasked with carefully vetting the manufacturing process of any potential 3rd-party parts partner. The fastest way to determine if a 3rd-party manufacturer aligns with OEM quality is to ask about ISO 13485 certification.

What is ISO 13485?

ISO refers to the International Organization for Standardization, a non-governmental organization representing 165 member nations. ISO has developed common technical, industrial, and commercial standards that facilitate global trade. These standards describe quality management systems (QMS) that help companies produce safe, reliable products across industries. ISO standards closely align with the regulatory requirements of its member countries, so ISO-certified businesses have an easier time entering the global market.

ISO 13485:2016 is a quality management system designed specifically for manufacturing medical devices. It requires companies to develop manufacturing processes that mitigate risk at every step and to provide comprehensive documentation of quality verification throughout the production cycle.

What's involved in ISO 13485 quality management?

Manufacturing replacement parts involves a complex, multiphase process. For example, Elite Biomedical Solutions specializes in infusion molding production of replacement components for devices like the BD Alaris IV pump. Creating a replacement part, such as a rear assembly case for the Alaris 8100, involves four phases before market production. These include:

  • Research
  • Development
  • Validation testing
  • Product launch

Each phase involves multiple team members contributing to several complicated processes. Product quality depends on executing every function in the production cycle correctly, down to the last detail. ISO 13485 QMS guidelines reduce errors and improve identification of design flaws and product abnormalities that may cause device failure or an adverse patient event.

Is ISO 13485 the same as FDA 21 CFR 820?

The U.S. Code of Federal Regulations (CFR) Title 21 part 820, which covers medical devices, requires a robust QMS. Third-party manufacturers can also voluntarily register to follow 21 CFR 820.

However, the QMS outlined in ISO 13485 is even more exhaustive than the current FDA regulation. In 2019, the FDA announced plans to harmonize with the global standard, but the COVID-19 pandemic delayed this initiative. Although the exact timeline remains unknown, the FDA has expressed that it still intends to map 21 CFR 820 to the QMS described in ISO 13485:2016.

Some, but not all, OEM's pursue ISO 13485 certification, which helps when bringing products to the international market. It's less common among 3rd-party manufacturers because many companies focus on turning out products quickly to increase profits.

Strong quality management requires some extra time and money. But cutting corners in manufacturing doesn't always increase ROI for the buyer. That's because lower quality parts are more likely to downgrade performance and increase safety risk.

What's the difference between ISO 9001 and ISO 13485?

Many businesses that make parts for OEM devices have ISO 9001:2015 certification. This is a step in the right direction, but ISO 9001 is a general standard applicable to any industry. It primarily focuses on procedures that ensure customer satisfaction.

However, biomedical equipment serves a very different purpose than other devices. Sure, customer satisfaction is important. But quality and risk mitigation can literally make a difference between life and death for clinical equipment used in patient care every day.

ISO 13485 includes all the basic requirements outlined in ISO 9001. But the additional rigorous risk management strategies of ISO 13485 give medical device manufacturers even more control over product quality. That level of control keeps patients safe, hospitals in compliance, and helps providers deliver effective, value-based medical care.

How does a business become ISO 13485 certified?

Certification begins when a manufacturer voluntarily implements an ISO 13485 QMS. This includes:

  • Required procedures
  • Design and development planning, review, and validation
  • Product and process verification
  • Device history files and Device history records
  • Supply chain verification

The most important part of the QMS is documentation. Beginning with design planning, manufacturers must record every process and quality checkpoint.

When the QMS is established, an independent certifying body, or registrar, visits the facility and audits all QMS documentation and processes. Once the registrar confirms the QMS meets all ISO 13485 requirements, they issue an ISO 13485 certificate. The business must pass an audit every three years to maintain certification.

To verify an ISO 13485 certification, use the International Accreditation Forum’s certificate database.

What does ISO 13485 certification really mean for health systems?

Partnering with an ISO 13485 certified 3rd-party manufacturer gives hospital purchasing agents peace of mind. It guarantees a high level of quality and indicates the partner intends to stand by the health system in the event of product failure.

Choosing a business that commits to following ISO 13485 guidelines impacts the bottom line. Elite’s products, including the rear assembly case for Alaris 8100, typically cost about 30% less than OEM replacement components. That can substantially boost ROI without sacrificing performance or safety.

Elite Biomedical Solutions is ISO 13485 certified, and FDA registered. Elite proudly manufactures all products in the U.S.A. For more information or to schedule a QMS demonstration, contact us today.

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