QTS offers complete medical device outsourcing services including simple and complex assembly, packaging, validation, sterilization and testing services. We offer clients comprehensive outsourcing for project completion or an a la carte menu of services to suit your unique needs. Whether you have one project or multiple projects requiring medical device outsourcing, we are fully equipped and staffed to handle it.

An overview of the barcode verification process and factors to consider with the recently implemented UDI rule. Our experts also review common challenges to barcode quality and answer questions.

Presentation Outline:

• UDI & Barcodes
• Verification Process & Attributes
• Controlling Quality

Are you feeling a bit overwhelmed and confused by Dose Audits? In this Dose Audits 101 webinar, you will learn what Dose Audits are, how they are performed and why they are so important. We will also cover some of the common challenges with Dose Audits and have our sterilization expert available to answer questions.

Presentation Outline:

• Dose Audits: What, Why & How
• Timing & Scheduling
• Common Challenges

Join QTS as our expert compares a traditional medical device packaging approach with an alternative approach that could save you time and resources.

Presentation Outline:

• Package Validation Timelines & Requirements
• Reducing Time & Expense

In this webinar our experts discuss what endotoxins are, where they come from, and strategies to help you mitigate risk. We will also discuss recent FDA guidance and how this may impact your medical device.

Presentation Outline:

• Microbiology of Endotoxins
• Testing for Endotoxins
• FDA Guidance
• Mitigating Risk

As the medical device industry trends towards single-use medical devices, there is increasing demand for more robust cleaning processes. In this engaging webinar, we will discuss different types of cleaning, key factors to consider for your specific device, selecting appropriate tests & methods, and much more.

Presentation Outline:

• Cleaning for single-use medical devices
• Understanding various cleaning methods
• Selecting appropriate cleaning markers
• Establishing acceptance criteria for validations

Have you adjusted your labels for compliance with the new European Union Medical Device Regulation? In this webinar we discuss the impacts the EU MDR will have on your medical device labeling.

Presentation Outline:

• Changes to labeling requirements in the new EU MDR
• UDI in the European Union and the EUDAMED Database
• IFU Changes and Patient Implant Cards

New Sterility Assurance Strategies for Products Sensitive to Sterilization Processes

For a healthcare product to be considered “sterile,” the traditional options that have been accessible to a manufacturer are either terminal sterilization to a maximal sterility assurance level (SAL) of 10^–6 or aseptic processing. While terminal sterilization is conducted on product after it is sealed in its sterile barrier packaging system, aseptic processing involves the handling of sterile components within a controlled environment, followed by the finished product being introduced into a sterilized package or container.

This research paper was originally published in the October 2021 issue of AAMI News, posted with permission from AAMI. Any other distribution of AAMI-copyrighted material requires written permission from AAMI.

In June of 2019, QTS Principal Sterilization Specialist Sopheak Srun attended the 10th Annual Kilmer Conference in Dublin, Ireland. The Kilmer Conference is an invite-only conference hosted by Johnson & Johnson and is a global forum for exchanging ideas within the sterility assurance community. Concepts and research presented at previous Kilmer Conferences have helped to shape many of the standards for assurance of sterility that we all use today.

Sopheak has written an in-depth summary of his experiences and takeaways from the recent conference – download his recap here.

QTS Principal Sterilization Specialist, Sopheak Srun, presented these slides at the AAMI Sterilization Standards Committee Microbiological Methods Working Group (WG08) meeting in Arlington, VA, on March 21, 2019.

The objective of the presentation was to educate other WG08 members on the expanded guidance for alternatives to batch testing.

The vast majority of hospital-acquired infections (HAI) arise from human-borne contamination from the workforce, the clinical environment, less-than-aseptic handling techniques, and the patients themselves. Nonetheless, the requirement for a maximal sterility assurance level (SAL) of a terminally sterilized product has remained at 10^-6, which is the probability of one in one million that a single viable microorganism will be on a product after sterilization. This paper presents a probabilistic model that predicts choosing an SAL greater than 10^-6 does not have a statistically significant impact on the incidence of surgical site infections.

This research paper was originally published in the May/June 2012 issue of BI&T (Biomedical Instrumentation & Technology), a bimonthly, peer-reviewed journal from the Association for the Advancement of Medical Instrumentation. Posted with permission from AAMI. Any other distribution of AAMI-copyrighted material requires written permission from AAMI.

Achieving a sterility assurance level (SAL) of 10^-6 often requires sterilization cycles that are expensive and might have adverse effects on materials. ANSI/AAMI ST67:2011 allows for performing risk analyses of alternate SALs and Annex C of that standard provides one example, but there are few published examples of such a risk analysis. If a statistical model based on standard academic statistical practices is used, the effects on the surgical site infection (SSI) rate of removing devices, adding devices, and changing a device SAL can be estimated. The use of probability statistics offers a practical approach for analyzing the impact of alternate device SALs.

This article was originally published by the Association for the Advancement of Medical Instrumentation in the 2013 peer-reviewed publication Industrial Sterilization-Research from the Field, available here. Posted with permission from AAMI. Any other distribution of AAMI-copyrighted material requires written permission from AAMI.

Overview of ISO 11607 (Packaging for terminally sterilized medical devices) and examples of real-world applications of the standard for discussion.Overview of ISO 11607 (Packaging for terminally sterilized medical devices) and examples of real-world applications of the standard for discussion.

Medical devices that are oxygen sensitive must be packaged using equipment that can modify the atmosphere of the package. The presentation will address: When does this need to be done? What is the best equipment to use and how do you test the package atmosphere? What difficulties do we know today about this process and what is being done to make it better?

The Final UDI Rule was released in the Code of Federal Regulations on September 24, 2013, with implementation for Class III device labeling in 2014. Manufacturers’ compliance with the UDI regulations requires effort on several fronts within companies including: Manufacturing, Labeling, Quality Assurance, Regulatory, and Information Technology and Enterprise Master Data. In other words, UDI is not ”just a barcode.” In this two-part seminar we will review some of the most critical requirements and impacts for medical device manufacturers.

Presentation Outline:

• Specific requirements contained within the Final UDI Rule, changes from the proposed rule to Final Rule and important details within the Final Rule
• Impacts related to your choice of Issuing Agency
• Industry challenges presented by the UDI Rule
• How the UDI requirements will impact manufacturers

The Final UDI Rule was released in the Code of Federal Regulations on September 24, 2013, with implementation for Class III device labeling in 2014. Manufacturers’ compliance with the UDI regulations requires effort on several fronts within companies including: Manufacturing, Labeling, Quality Assurance, Regulatory, and Information Technology and Enterprise Master Data. In other words, UDI is not ”just a barcode.” In this two-part seminar we will review some of the most critical requirements and impacts for medical device manufacturers.

Presentation Outline:

• Production Impacts: Verifying UDIs, controlled sources, UDI grading, and label printing records.
• Design Impacts: GS1 and HIBCC, code types supported
• DMR Impacts: Generation of GS1 codes, communication of UDI to QTS, and obligation to GUDID
• Sales Order/Job Impacts
• Background Work Necessary: Existing Customer Footprints

Quick answers about the Final UDI Rule from the FDA.

Overview of requirements, steps for implementation, and how QTS can help with UDI compliance.