The Solution to Your Testing Needs
Medical Device Testing: Testing Includes:
- Adhesives, Tapes
- Artificial Skin
- Bags
- Catheters
- Cables, Wires
- Coated Stents
- Intraocular Lens Injectors
- IV Solution Bags
- Knives
- Needles
- Pills & Tablets
- Staples
- Stents
- Sutures
- Syringes
- Tubes, Cannulae
Note: These are just a few of many other...
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Medical Device Contract Manufacturing & Assembly
Pre-Validated Medical Packaging: PRO-TECH carries a host of pre-validated pouches and trays that are stocked and can get you to market quickly with lower costs. These materials have been tested on our equipment with aging studies for up to 5 years.
Our components are made from premium materials and can be used in various...
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TM Electronics WORKER™: Leak & Flow Tester: Efficient and reliable leak and flow tester, perfect for checking the integrity of everything from flexible packaging to electronical products.
The TM Electronics WORKER™ is an affordable, dependable tool for your day-in, day-out leak testing, flow testing, and occlusion testing requirements....
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Product Testing, Certification and Inspection Partner.
Intertek's Packaging Validation & Testing Services excel at ensuring the performance, safety, and compliance of medical device packaging, leveraging our global network of laboratories for comprehensive support and expertise. Our suite includes quality determination, troubleshooting, certification, and tailored testing methodologies such as ISTA standard evaluations, ensuring that packaging meets rigorous international standards. We specialize in creating custom testing protocols for unique packaging designs, offering evaluations on mechanical properties, chemical analysis, and environmental impact to meet the specific needs of the medical device industry, and ensuring that products are delivered safely and intact to consumers and healthcare providers.
At TÜV SÜD, our comprehensive packaging validation & testing program is engineered to guarantee the protection and integrity of medical devices, ensuring they arrive safely in the hands of end-users. Capitalizing on our International Safe Transit Association (ISTA) accredited testing facilities, we simulate a variety of mechanical and environmental conditions that products may encounter to certify packaging design to ISO 11607 standards. By partnering with us and aligning with our program, medical device manufacturers benefit from expertise that not only validates the resilience of packaging systems but also optimizes materials to strike a balance between cost-efficiency and regulatory compliance.
Testing & Consulting Services Independent Testing & Research
Smithers provides a robust portfolio of Packaging Validation & Testing services that precisely mimic real-world supply chain physical and climatic events, ensuring that packaging for medical devices withstands the rigors of transit. Utilizing our ISTA-certified and ISO 17025-accredited laboratories, we offer expertise in climatic conditioning, compression, drop and impact, vibration, and pressure differentiation tests, integral to maintaining product integrity from manufacturing to the end user. Whether for product validation, packaging validation, troubleshooting shipment issues, or regulatory compliance, our comprehensive, state-of-the-art testing methodologies facilitate optimal packaging solutions that guarantee safety, durability, and regulatory adherence.
At Westpak Inc., our package validation and testing services are geared towards excellence in protecting and preserving the efficacy and safety of medical devices from the point of manufacture to end-user delivery. Employing ASTM and ISTA standards, our state-of-the-art laboratories specialize in a plethora of rigorous testing methods, including environmental conditioning, drop, vibration, and compression testing, to ensure robust packaging validation that aligns with ISO 11607 requirements. Our expertise and thorough testing practices afford you and all medical device manufacturers the confidence that your products will withstand the rigors of distribution, maintaining integrity and compliance through to the final destination.
QA Consulting leverages intricate knowledge of ISO 11607 standards to ensure medical device packaging meets the pinnacle of sterile requirements, ensuring protection throughout a product's lifecycle. Our rigorous worst-case scenario testing assesses package strength, integrity, and microbial contamination risk, providing robust baseline evidence for your packaging's reliability. With a strong focus on cross-departmental collaboration and deep expertise in medical device microbiology and sterilization, we offer comprehensive package validation services tailored to navigate the complexities of medical device markets, giving you the confidence your products will reach the end-user in pristine condition.
Network Partners Group provides holistic medical device packaging engineering services, leveraging our team of highly trained, experienced, and degree-qualified packaging professionals to design, develop, and validate impactful packaging solutions to provide immediate, valuable contributions to your existing medical device operations. Our services include the execution of all stages of package engineering, from prototyping and testing to addressing sterile barrier systems, equipping you with the tools to successfully navigate the environmental hazards of global transportation and supply chain complexities.
Cambridge Polymer Group specializes in comprehensive packaging validation testing & analysis services focused on ensuring the safety, longevity, and integrity of packaging for medical devices, including 510(k) clearance assistance, analytical testing, and detailed reporting to ensure that medical packaging meets rigorous FDA scrutiny under our ISO 9001:2015 quality management system. Leveraging advanced methodologies and adherence to relevant standards, including ASTM F1980, ASTM F2097, USP <1663>, USP <1664>, and EU No. 10/2011, we provide a solid foundation for your product safety and integrity, emphasizing our commitment to quality and regulatory compliance.
