Medical

Manufacture with Confidence with Our Third-Party Audits

Your medical device might look and operate right, but if it isn’t fully safe to use, it defeats your purpose and can lead to an expensive, troublesome recall.

Claiming safety compliance does not indicate a medical device–plastics injection molder is being held to premium standards. Many companies are merely following basic guidelines. HQC substantially enhances safety by arranging third-party NSF International audits of both our materials and our production and quality systems.

HQC is dual certified with ISO 13485 for medical devices and Safe Quality Food (SQF) Institute Level 3 for food, the institute’s highest rating. Provided by a separate auditing firm, our ISO 13485 certification authenticates our medical-packaging safety. The SQF Level 3 distinction identifies HQC as meeting the same safety requirements as a food or beverage packaging company’s.

In addition, HQC technicians are educated (i.e. more than trained) in safety for injection molding of medical-grade plastics. They must pass written and verbal tests before they can work in production.

Our internal quality systems include Good Manufacturing Practice (GMP) and Hazard Analysis Critical Control Point (HACCP) plans to track our manufacturing processes and prevent mistakes in products. This becomes particularly valuable to isolating and investigating an issue in the event of a recall. We perform our own mock audits for recall as well.

Comprehensive safety for medical devices goes well past our own intensive auditing – several HQC customers schedule their own audits of our materials and processes to verify conformance to FDA standards. The independent audits involve sending our products to laboratories for analyzation.

Many of our finished products also are sent for e-beam sterilization, which requires specific medical-grade plastics from a clean, safe manufacturing facility. HQC has multiple soft-sided clean rooms for injection molding and assembly of medical devices.

In addition, in certain cases, a third party will conduct bioburden testing to ensure our production rooms are clear of high-burdened areas on which bacteria can build.

Outperform Competitors with Inventive Problem-Solving

HQC supplies your business with much more than safety, injection molding and support services for your medical devices. We also equip you with original ideas and solutions for your manufacturing challenges.

As but one example, an HQC customer was shipping a similar medical device to different locations. They wanted to mold, assemble and shrink-wrap multiple components but were running into issues with their current supplier’s automation. The supplier did not have the resources to troubleshoot the problem nor coordinate the assembly equipment into the process.

HQC integrated the assemblies and then inspected and shrink-wrapped them to create a finished product ready for e-beam sterilization.

Customers often bring us their medical-device concept to determine if it is suited for injection molding. HQC reviews the concept and advises the customer on both the product’s manufacturability and its design. Our design recommendations consistently reduce tooling costs and prevent issues that can arise from not understanding the limitations of medical plastics.