Medical Diagnostic Device Housing: Clean Room PC Injection Molding

Mon, 10 Feb 2025 00:00:00 +0000

Project Overview

A medical device OEM developing a portable point-of-care diagnostic analyzer required a two-part plastic housing for the device enclosure. The housing needed to be produced in USP Class VI polycarbonate, molded in a clean room environment, and supported by full lot traceability documentation to support the client’s 510(k) submission and Device History Record.

The device enclosure is a Class II medical device component — non-implantable, patient-facing, requiring surface biocompatibility and resistance to hospital-grade disinfectants.

Medical Grade Injection Molding: What You Need to Know About FDA Compliance

Wed, 15 Jan 2025 00:00:00 +0000

Sourcing plastic injection-molded components for a medical device is fundamentally different from sourcing industrial parts. The stakes — patient safety, regulatory approval, product liability — demand a different level of rigor from both the buyer and the supplier. This guide covers what medical device OEMs and their supply chain teams need to understand before selecting a plastic molding supplier.

What “FDA Compliant” Actually Means for Molded Parts

“FDA compliant” is a term that gets used loosely. For plastic injection-molded components used in medical devices, compliance typically refers to one or more of the following:

Medical on JBRplas

Medical Diagnostic Device Housing: Clean Room PC Injection Molding

Project Overview

Medical Grade Injection Molding: What You Need to Know About FDA Compliance

What “FDA Compliant” Actually Means for Molded Parts