Designing medical devices requires adherence to the highest safety and quality standards. It is therefore essential for designers to work with medical device manufacturing companies who follow International Organization for Standardization (ISO) 13485 guidelines. If you’re among such designers, learn more about this rule, including why it was created and what makes it so important.

How ISO 13485 Affects Medical Device Design

What Is the ISO? 

The International Organization for Standardization, a standard-setting, nongovernmental organization based in Geneva, Switzerland, created regulation 13485 in 1996. The organization has so far created over 20,000 standards regarding healthcare, agriculture, and food safety manufacturing to provide consumers with safe, quality products. These products adhere to international manufacturing standards created by representatives from the organization’s 164 participating countries. 

What the Rule Covers

ISO 13485 addresses medical devices, quality management systems, and regulatory requirements. It was created for organizations that design, produce, install, store, distribute, and service medical devices. The rules apply to organizations of any size no matter what type of medical devices they create; however, guidelines vary in accordance with the product. The stipulations for heart monitors, for example, aren’t the same as those for mobility devices.

How Periodic Reviews Help

ISO 13485 undergoes extensive reviews every five years to determine if any changes are necessary to further protect those using devices, such as updates regarding medical device manufacturing management or technology.

Why Companies Follow ISO 13485

It’s critical that designers develop relationships with manufacturing companies that strictly adhere to ISO 13485 guidelines. Companies without certification from this internationally recognized quality assurance group should always be avoided, as faulty materials, methods, or technology should be used. Aside from compromising the health of users, poorly made products also lead to recalls and legal liabilities. Noncompliance with the rules can also harm the medical professionals who rely on these products to perform their duties.

Working with medical device manufacturing companies who follow this standard and any related updates will help preserve your professional reputation as an ethical designer developing high-quality products. The standard is also necessary for competitive advantages within a constantly evolving industry.

Rely on the medical device manufacturing services from Pacific Integrated Manufacturing Inc. for ISO 13485-certified products. The Bonita, CA-based global leader in healthcare manufacturing features a 50,000 square-foot facility where technicians provide contract services such as assembly kitting, thermoplastics, packaging, material procurement, and sterilization management. Call (619) 921-3464 today for a free quote or learn more about services online.