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Eurofins Medical Device Services US
เข้าร่วมเมื่อ 8 มิ.ย. 2017
From implants and instruments to single-use and combination products, as well as active electronic devices, Eurofins Medical Device Services offers the optimal testing strategy for all types of Class I, II, and III devices. We help verify product designs, confirm safety and efficacy, and ensure user needs are met.
With over 40 years of experience in preclinical testing and regulatory submissions, our scientists assist companies in navigating international regulatory requirements and scientific trends. Our 20+ state-of-the-art facilities across North America, Europe, and Asia Pacific provide a full scope of testing services, including Analytical Chemistry, Microbiology, Biocompatibility, Electrical & Mechanical, Packaging, Stability Testing, and Storage.
We are committed to global regulatory standards and quality systems compliant with cGMP, GLP, and ISO 17025, conducting tests in accordance with ISO, ASTM, ANSI, and AAMI standards to meet our customers' unique needs.
With over 40 years of experience in preclinical testing and regulatory submissions, our scientists assist companies in navigating international regulatory requirements and scientific trends. Our 20+ state-of-the-art facilities across North America, Europe, and Asia Pacific provide a full scope of testing services, including Analytical Chemistry, Microbiology, Biocompatibility, Electrical & Mechanical, Packaging, Stability Testing, and Storage.
We are committed to global regulatory standards and quality systems compliant with cGMP, GLP, and ISO 17025, conducting tests in accordance with ISO, ASTM, ANSI, and AAMI standards to meet our customers' unique 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/
มุมมอง: 371
วีดีโอ
Extractables & Leachables Testing via new technology. Agilent 6546 Q-TOF LC-MS Preview
มุมมอง 4872 ปีที่แล้ว
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
มุมมอง 5392 ปีที่แล้ว
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
มุมมอง 4542 ปีที่แล้ว
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
มุมมอง 6302 ปีที่แล้ว
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
มุมมอง 3.8K3 ปีที่แล้ว
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
มุมมอง 2.6K3 ปีที่แล้ว
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
มุมมอง 2.7K4 ปีที่แล้ว
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
มุมมอง 3K5 ปีที่แล้ว
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
มุมมอง 8955 ปีที่แล้ว
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
มุมมอง 10K5 ปีที่แล้ว
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
มุมมอง 1.2K6 ปีที่แล้ว
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
มุมมอง 7K6 ปีที่แล้ว
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
มุมมอง 8726 ปีที่แล้ว
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
มุมมอง 5K6 ปีที่แล้ว
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
มุมมอง 1.5K7 ปีที่แล้ว
Biocompatibility Testing of Combination Products & Medical Devices: New Regulatory Guidance
Developing a Testing Plan for Medical Device Design Verification
มุมมอง 23K7 ปีที่แล้ว
Developing a Testing Plan for Medical Device Design Verification
Biocompatibility Basics: Making sense of the Annex A Matrix
มุมมอง 6907 ปีที่แล้ว
Biocompatibility Basics: Making sense of the Annex A Matrix
Chemical Characterization: The Starting Point for Biological Evaluations
มุมมอง 8327 ปีที่แล้ว
Chemical Characterization: The Starting Point for Biological Evaluations
Developing Test Strategies Per the New ISO 10993-1: Current Status and Upcoming Changes
มุมมอง 7687 ปีที่แล้ว
Developing Test Strategies Per the New ISO 10993-1: Current Status and Upcoming Changes
Changes in Europe’s Medical Device Regulations: Consequences for Manufacturers
มุมมอง 3.4K7 ปีที่แล้ว
Changes in Europe’s Medical Device Regulations: Consequences for Manufacturers