A main challenge in manufacturing medical devices is understanding their role and application during concept and design. As leaders in medical injection molding, HQC supports and advises your business where guidance will profit you most. We help you choose the right medical plastics, keep materials consistent and achieve full device utility. HQC also excels in swift response times and prompt prototype turnarounds.
HQC often molds and assembles medical devices for neonatal/infant care, assembles surgical tubing and completes assemblies of vial collections including the capping and shrink-banding of components.
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.
HQC specializes in both rigid and flexible packaging, including that which requires two-component or two-material molds. HQC performs injection molding of medical plastics with Radio Frequency Identification (RFID) as well.
HQC also provides value-added services and capabilities such as collection-system assemblies, ultrasonics, laser marking, serial numbering and pad printing. We can also assemble tubes with both solvent and silicone adhesion components.
We can further supply you with certificates of conformance that detail how your medical devices were manufactured, as well as how they achieved safety compliance.
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.
We are your resource for optimal safety, function and form for your medical devices with custom medical plastics. Contact us at (630) 820-5550 to further discuss your objectives.