Medical Device Qualified Supplier Directory
Quality Tech Services, LLC (QTS) Company Profile
Qualifications: ISO 13485, FDA Registered, Supplier to Medical Manufacturers, Exhibitor in at least 2 MD&M and/or MEDTEC shows
Markets Supplied: North America
QTS is a Medical Device Outsourcing company that provides the expertise, responsiveness and exceptional quality required to rapidly bring medical devices to a highly regulated market. We specialize in developing innovative solutions for a wide range of Medical Device manufacturing scenarios. As an FDA registered, ISO 13485 certified, MedAccred Sterile Device Packaging accredited and J-PMDA compliant company, QTS holds the highest in quality standards when assisting medical device companies with their assembly and packaging needs. Our certified class 10,000 cleanrooms provide controlled and monitored work areas to ensure the cleanliness and quality you require for your medical devices.Pre-validated Medical Packaging
QSEAL® Pre-validated Medical Packaging is an exclusive line of stock medical device packaging systems created in standard sizes for both tray and pouch-based systems. Because the system has already been designed, sourced and validated to ISO and medical industry standards, manufacturers can bring new products to market much faster – at the same time, lowering costs significantly.
Package Design Expertise
Medical device packaging requires attention to multiple design, distribution and market factors. QTS has deep expertise to help you define your needs and assist you in developing a package that is effective and appropriate to the distribution and use environments of your device.
Our medical device expertise combined with an extensive network of industry recognized and approved suppliers, allow us to secure reliable sources that meet your material requirements.
Medical packaging can lose its integrity as a result of dynamic events that occur during processing and/or distribution. QTS employs physical test methods that validate the package integrity has been maintained throughout all the phases of processing, handling and expected shelf life.
Label Development & Printing
From the design of your label to ensuring labels meet domestic and international label compliance requirements, QTS works diligently to deliver precise label printing for all your medical devices.
Critical Inspection Services
QTS offers a climate-controlled inspection suite, state-of-the-art equipment and certified inspection staff. Our inspection services provide the expertise and technology to help eliminate your need for large capital and overhead investments and in return, help to reduce costs and minimize risk.
QTS offers comprehensive medical device sterilization services. Certified staff microbiologists and sterilization specialists oversee the process, and we provide complete validation services including creating protocols, sample preparation, coordinating third-party laboratory testing, and submitting a final report to our clients.
Lab Testing Services
QTS coordinates contract laboratory testing services including, testing within a validation as well as for routine monitoring purposes. Partnering with QTS for laboratory testing helps you reduce the time and costs associated with managing an additional vendor.
Supply Chain Management
QTS maintains an extensive network of industry-recognized suppliers to increase efficiencies for our customers. Additionally, we can develop inspection approaches for your device that ensure defects are uncovered early and that quality is maintained throughout the entire manufacturing process.