We’ve provided you with all our best case studies, research, webinars and insights below for download.
Registration is required to access some of the resources below.
One quick registration below will give you access to all our resourcesQTS Brochure
Read details
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.
UDI Barcode Verification
Read details
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
Dose Audits 101
Read details
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
Utilizing Pre-Validated Packaging to Get Your Device to Market Faster
Read details
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
Endotoxins: What’s Your Plan?
Read details
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
Systems Approach to Medical Device Cleaning
Read details
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
Are Your Labels EU MDR Ready?
Read details
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
Sterility Assurance Strategies for Product Sensitive to Sterilization Processes
Read details
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.
2019 Kilmer Conference Recap
Read details
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.
Bacterial Endotoxins Testing: Alternatives to Batch Testing
Read details
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.
Medical Device SALs and Surgical Site Infections: A Mathematical Model
Read details
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.
Using Statistics as a Risk Analysis Tool for Selecting An Alternate SAL
Read details
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.
Case Studies and Practical Interpretations of ISO 11607
Read details
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.
Modified Atmosphere Packaging and Ultra-High Molecular Weight Polyethylene (UMPHE) Components
Read details
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?
Background of UDI and Preparing for Impacts (Part I)
Read details
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
Implementation of UDI (Part II)
Read details
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
Unique Device Identification (UDI) Frequently Asked Questions
Read details
Quick answers about the Final UDI Rule from the FDA.
UDI Best Practices for Implementation
Read details
Overview of requirements, steps for implementation, and how QTS can help with UDI compliance.
Identifiable and Sterile: Trends Driving Device Packaging (BONEZONE, March 2016)
Read details
In this article Gunderson and Nissen of QTS discuss how new UDI guidance and movement towards single-use, sterile products have impacted medical device labeling and outsourcing trends. Additionally, they note the importance of spending time with end-users and examining the package needs to be more cost-effective and efficient.
Perspectives on What’s Ahead in 2014 (Medical Device Technology, November/December 2013)
Read details
Key insights from industry leaders, including Gerry Gunderson of Quality Tech Services (QTS), regarding what’s in store for the medical device sector in the coming year.
Outsourcing Outlook on Cleanroom Manufacturing and Assembly (Medical Product and Manufacturing News, January/February 2011)
Read details
What criteria should an OEM consider when selecting an outsourcing partner with cleanroom capabilities? Bob Lord, Sales & Marketing Director at Quality Tech Services, provides some insights.
How Damage to Barcodes Affects Grading and Scannability
Read details
QTS Principal Project Engineer, Brian Nissen, shares with us how damage to Linear (1D) and Datamatrix (2D) barcodes can impact scannability and grading in the medical device supply chain.
To request access to a video recording of a webinar, please contact your QTS Account Manager or email us at info@qtspackage.com
close [x]