Polymers are some of the most commonly used materials in medical device manufacturing. Characterization of the relevant properties is key to ensure their quality and performance standards.
Medical grade polymer testing is integral to device development, improvement, and failure analysis investigations. With an experienced eye on current regulatory specifications, im体育APP’s highly qualified polymer experts have the expertise to help you improve and qualify your materials and products.
In addition to standard polymer characterization, we have developed techniques and capabilities specific to 制药s and medical devices, 包括:
- Gel permeation chromatography (GPC) of water-soluble polymers/excipients
- Gelatin bloom strength
- Pre-filled syringe extrusion force
- Syringe break and glide force
- Particulate counting and identification
Development of custom testing programs - 510 (k)计划 to compare medical devices to predicate devices
- Medical patch adhesion strength
- 驱动力量
- Chemical exposure testing (e.g. cleaners and antimicrobials)
- Evaluation of tissue adhesives
The im体育APP advantage
im体育APP is accredited to ISO/IEC 17025 through A2LA and the Standards Council of Canada and is regularly inspected by the 食物 and Drug Administration (FDA) and Health Canada. Our polymer scientists are experienced across a range of medical devices, including Class I, II, 和III设备.
As a comprehensive medical device testing partner, you’ll enjoy the benefit of a single source supplier for all of your testing needs, from feasibility and R&D to product development and production quality control. We offer a full suite of medical device testing, including mechanical testing, product qualification, material characterization and failure analysis.
For more information about our medical grade polymer testing, im体育APP 今天.
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