Understanding ISO 13485 & 510(k) Compliance for Medical Cable Manufacturers

When you're sourcing or building medical cables—especially for use in patient monitoring systems or OEM devices—understanding compliance requirements isn’t optional. It’s essential.

Whether you're a product engineer, procurement lead, or regulatory specialist, knowing what ISO 13485 and 510(k) clearance mean in the context of medical cable manufacturing will help you choose the right partner—and protect your device pipeline.

What is ISO 13485?

ISO 13485:2016 is an internationally recognized quality management system (QMS) standard specifically for medical devices and related services.

• Documented processes for design and production
• Verified and validated materials sourcing
• Traceability across every unit produced
• Risk management and quality controls baked into their operations

In short: it’s the difference between “we make cables” and “we make cables safe for medical devices.”

Orantech is proudly ISO 13485:2016 certified, and we audit our processes regularly to maintain compliance.

Why ISO 13485 Matters for Medical Cables

• Ensures repeatable, consistent quality
• Guarantees cable production follows controlled procedures
• Reduces the risk of product recalls or regulatory rejection
• Aligns with FDA and EU MDR expectations for component suppliers

Whether you’re building a Class II device or sourcing reusable patient cables, ISO 13485 helps ensure your components meet regulatory expectations.

What is a 510(k) Clearance?

A 510(k) is a premarket submission to the U.S. Food & Drug Administration (FDA) that demonstrates a medical device is substantially equivalent to an already legally marketed device.

While many cable manufacturers are not required to submit 510(k) clearances themselves (unless they're marketing a finished device), your supplier’s familiarity with 510(k) processes can be a huge advantage—especially for OEMs.

Orantech manufactures cables that support devices with active 510(k) clearances and provides technical documentation and traceability to help partners meet their submission goals.

What to Look For in a Certified Cable Manufacturer

• ISO 13485:2016 certification (current and verifiable)
• FDA registration (U.S. market only)
• CE marking or EU MDR alignment
• Cleanroom manufacturing or validated assembly space
• Access to Design History Files (DHF) or production traceability
• Material declarations and biocompatibility statements

How Orantech Helps OEMs and Device Developers

• Certified to ISO 13485:2016
• FDA-registered manufacturing site
• Supplies OEM-quality cables for GE, Philips, and Masimo-compatible systems
• Offers documentation for 510(k)-relevant components
• Custom builds based on your technical drawings, specs, or device needs

Final Thoughts: Compliance is a Partnership

Choosing a cable manufacturer with ISO 13485 certification and regulatory expertise protects your device, your business, and your patients.

At Orantech, we bring more than high-performance cables—we bring proven, auditable quality that supports every phase of your product lifecycle.