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Eurofins Medical Device Testing
Приєднався 8 чер 2017
With 16 laboratories in North America, Europe and Asia Pacific, Eurofins Medical Device Testing offers regulatory compliance expertise and experienced GMP/GLP/ISO 17025 testing to ensure rapid turnaround times with the highest level of service, and most advanced technologies for your analytical chemical, microbiological, biocompatibility, electrical, mechanical and package testing needs.
Maintain Sterile Barrier Integrity with Eurofins
Sterile Barrier Integrity Testing is critical throughout the course of distribution and storage for all terminally sterilized medical devices. Let Eurofins Medical Device Testing determine the most appropriate testing method based on your device and/or packaging configurations to ensure device integrity per ISO 11607, ASTM F1929 or ASTM F2096. Watch the video to learn more.
Contact us with your Package Testing needs or questions: bpt-pages.eurofins.com/MD-Contact-US.html
Click to learn more about our Sterile Barrier and Seal Integrity Testing Services: www.eurofins.com/medical-device/services/packaging-seal-integrity/sterile-barrier-system/
Contact us with your Package Testing needs or questions: bpt-pages.eurofins.com/MD-Contact-US.html
Click to learn more about our Sterile Barrier and Seal Integrity Testing Services: www.eurofins.com/medical-device/services/packaging-seal-integrity/sterile-barrier-system/
Переглядів: 327
Відео
Extractables & Leachables Testing via new technology. Agilent 6546 Q-TOF LC-MS Preview
Переглядів 4712 роки тому
We are happy to announce the expansion of our already very powerful equipment within the Analytics department of our Munich laboratory. Our Munich laboratory has acquired an Agilent 6546 Q-TOF LC-MS (Liquid Chromatography-Time of Flight Mass Spectrometer) as their newest piece of state-of-the art equipment. The high sensitivity, wide dynamic range and high mass resolution with an extended datab...
Endure Storage with Eurofins’ Shelf Life Testing
Переглядів 4412 роки тому
Any medical device brought to market must have an expiration date, backed by shelf life testing. Eurofins Medical Device Testing’s shelf life and accelerated aging testing services ensure your device meets its intended use just as effectively after years of storage as the day it was manufactured. With more than 200,000 ft3 of storage space, and a wide range of environmental chambers for predefi...
Ensure Your Device Survives Global Transport
Переглядів 3722 роки тому
No matter how or where your device is shipped, it is important to ensure your product will survive the rigors of global transit. Our state-of-the-art laboratory testing very precisely simulates various standard and custom distribution cycles per ISO 11607 and ASTM D4169, for the environmental conditions your packaging will encounter during transit. As you finalize your packaging designs, and pr...
Your Trusted Package Testing Partner
Переглядів 5152 роки тому
Eurofins Medical Device Testing’s state-of-the-art Package Testing Lab is GMP, ISTA certified and ISO 17025 accredited to help evaluate every aspect of your packaging and labeling configurations. Our experts help perform functional testing, material testing, and accelerated and/or real time aging studies of primary and secondary packaging configurations to ensure your product will survive the r...
Packaging Validation of Medical Devices - Impact of the Revisions of ISO 11607 & Suitable Strategies
Переглядів 3,6 тис.3 роки тому
The medical device industry is a fast changing environment that is continuously adapting to the constant challenges within the medical landscape. One such challenge is designing an evaluation plan for fulfilling the requirements for a suitable and validated packaging system using package testing that will comply with FDA or international health and safety regulations. This webinar will mainly f...
Testing Requirements for a Successful Sterilization Validation
Переглядів 2,3 тис.3 роки тому
Today there are a range of sterilization techniques used to terminally sterilize medical devices. This webinar will provide a general overview of the requirements for planning and executing sterilization validations. Using two of the more common sterilization techniques, ethylene oxide (ISO11135) and irradiation (ISO11137), we will review in detail the testing requirements underpinning their va...
Chemical Characterization/Toxicological Risk Assessments: A Smart Approach to Biological Evaluation
Переглядів 2,7 тис.4 роки тому
Upcoming changes to the general guidance for biocompatibility testing will soon dictate a new approach to biological risk assessment for all types of medical devices. Regulatory agencies will require a more rigorous Chemical Characterization as a prerequisite for biological risk assessment, followed by Toxicological Risk Assessments, to elucidate the need for further testing. During this webina...
Chemical Characterization: How to Initiate the Biological Evaluation of Medical Devices
Переглядів 2,9 тис.5 років тому
Chemical characterization is the initial step in the biological evaluation of any medical device with direct or indirect patient contact. If a chemical characterization assessment on a medical device is conducted and evaluated appropriately, it can potentially minimize the need for additional biological testing. The recent revision to ISO 10993-1 highlights the importance of chemical characteri...
Threat Modeling Medical Devices
Переглядів 8645 років тому
Learn threat modeling and risk identification around medical devices. This will include a review of relevant threats, attack surfaces, testing methodologies, and test criterions. The presentation will focus on current issues and solutions in medical device security testing
Container-Closure Integrity Testing for Drug Delivery Devices
Переглядів 9 тис.5 років тому
Container-closure integrity is evaluated during all phases of the product-package life cycle for a drug delivery device from package development, as part of the design verification study, to manufacturing, through commercial stability, and in many cases in lieu of sterility testing. So, what exactly is meant by the term container-closure integrity, and how can an appropriate leak testing techno...
Package Testing: Developing a Test Plan that Avoids Product Launch
Переглядів 1,2 тис.6 років тому
The medical device industry is a fast-changing environment that is continuously adapting to the constant challenges within the medical landscape. One such challenge is designing safe packaging that will protect products during shipping and transport while simultaneously complying with FDA or international health and safety regulations. Many medical device companies struggle with the development...
Sterility Validation 101: Ensuring a robust sterilization validation program from start to finish
Переглядів 6 тис.6 років тому
The mapping of a successful sterilization validation program for medical devices can be challenging. From assessing the impact of your manufacturing environment, to your packaging design and choice of sterilization methods, many factors will impact how you validate your sterilization process. While parts of the program are simple, others are very complex, and it can be difficult to know where t...
Biological Evaluation of Breathing Gas Pathways of Medical Devices, A New ISO Standard
Переглядів 8226 років тому
With the recent development of ISO 18562, an important gap in the biological evaluation of medical devices has been addressed. ISO 10993, which covers biological evaluation of medical devices, does not sufficiently address the biological evaluation of the gas pathways of medical devices. ISO 18562 represents the application of the best-known science, in order to improve patient safety by addres...
Endotoxin Testing: Make Sure FDAs New Guidance Doesn’t Delay Your Product Launch
Переглядів 5 тис.6 років тому
Learn about endotoxin testing, its history, the current status and expectations of the FDA, and the establishment of current limits, as well as an interactive discussion on the new guidance, the current impact, and what may be coming.
Biocompatibility Testing of Combination Products & Medical Devices: New Regulatory Guidance
Переглядів 1,4 тис.6 років тому
Biocompatibility Testing of Combination Products & Medical Devices: New Regulatory Guidance
Developing a Testing Plan for Medical Device Design Verification
Переглядів 22 тис.7 років тому
Developing a Testing Plan for Medical Device Design Verification
Biocompatibility Basics: Making sense of the Annex A Matrix
Переглядів 6727 років тому
Biocompatibility Basics: Making sense of the Annex A Matrix
Chemical Characterization: The Starting Point for Biological Evaluations
Переглядів 7787 років тому
Chemical Characterization: The Starting Point for Biological Evaluations
Developing Test Strategies Per the New ISO 10993-1: Current Status and Upcoming Changes
Переглядів 7607 років тому
Developing Test Strategies Per the New ISO 10993-1: Current Status and Upcoming Changes
Changes in Europe’s Medical Device Regulations: Consequences for Manufacturers
Переглядів 3,4 тис.7 років тому
Changes in Europe’s Medical Device Regulations: Consequences for Manufacturers