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Learn about the essential testing methods and standards that ensure the safety and effectiveness of medical devices.
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Released By Element
May 26, 2021
With over 190 laboratories worldwide and more than 6,700 experts, Element offers medical device product evaluation and mechanical testing services to medical device manufacturers. In our ISO 17025 accredited medical laboratories, we work with medical device and pharmaceutical companies to complete everything from initial research and development studies to testing for full regulatory submissions and post market validations. Element provides a comprehensive range of material, electrical and design characterization testing on orthopedic, cardiovascular, raw materials, and implantable, diagnostic and therapeutic equipment. Our engaged experts have experience in every stage of the process, understanding that decreasing time to market is key. As a result, we have designed our services as a partnership with our customers – driving down lead time, minimizing vendor management and working as an extension of your R&D and manufacturing teams. With the broadest range of technical services in the medical industry alongside a global platform, Element delivers solutions when and where you need them. With changing regulatory environments in Europe and the US, our experts can help navigate questions, protocols, and provide regulatory submission support both internally and through our testing partners. We understand the challenges it takes to bring your device to market and our expertise can mitigate risk which results in better decisions, improved planning, and prevents delays and regulatory questions. Our experts routinely participate in ASTM, ISO and other technical committees, ensuring Element is at the forefront of the newest methods and trends. Download the Brochure via the widget to right to learn more
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