Our whitepapers allow you to dig deeper into topics and understand the science behind our service as well as ways we can help solve your business challenges.
- Single Use & Newly Manufactured Device Cleaning Validations Performing a cleaning validation during the initial phase of a device’s lifecycle aids manufacturers in complying with current good manufacturing practices (CGMP) and quality system (QS) regulation as set forth by FDA for medical device manufacturers. Download the whitepaper to learn more.
- Current Regulatory Landscape for EO Residual Levels in Medical Devices Ethylene oxide gas remains a popular choice for terminal sterilization because of its effectiveness and its suitability for use with plastic and other heat-sensitive device materials. This whitepaper covers what manufacturers nee to know now and what the experts at Nelson Labs and Sterigenics think is on the horizon.
- Successful Medical Device Cleaning Validations: What You Need to Know Validating cleaning instructions for a tray of reusable orthopedic devices is an important milestone on the path to obtaining FDA clearance for those devices. Download the whitepaper to learn more.
- Establishing Bioburden Alert and Action Levels Most national and international standards regarding bioburden, sterilization, or environmental testing refer to establishing alert and action levels to assist in demonstrating continued control over a process or product. Download the whitepaper to learn more.
- Considerations for Third-Party Reprocessing of Single-Use Medical Devices Reusing single-use devices that have been safely reprocessed by a third-party reprocessor can enable healthcare providers to maintain high-quality patient care while saving on costs and reducing medical waste. Download the whitepaper to learn more.
- Considerations for Sterilization and Biocompatibility of 3D-Printed Orthopedic Devices Download this whitepaper to learn about the various biocompatibility and sterilization considerations surrounding 3D-printed orthopedic devices.
- 3D Printed Medical Devices and Biocompatibility Whitepaper 3D printed medical devices require versatile approaches to the assessment of their biocompatibility that consider several factors. Download the whitepaper to learn more.
- How Chemical Characterization Can Supplement & Support Biocompatibility Testing Using analytical chemistry and data from the compound libraries to assess the finished device can yield more specific data about these extractable compounds than biocompatibility testing. The known properties of the compounds can then be used to create a toxicological risk or safety assessment based on the predicted biological response to the compounds. Download the whitepaper to learn more.
- A Particle of Prevention Is Worth a Pound of Cure: The Significant Benefits of Premarket & Postmarket Particulate Testing of Cardiovascular Devices Device manufacturers that incorporate particulate testing into their product-development plans early are better equipped to navigate the regulatory clearance process and potentially reduce time to market.