Medical Grade Polymer Testing
Streamline your medical device development with comprehensive polymer testing that supports regulatory approval and optimal product performance. Our FDA-inspected facilities deliver specialized characterization, validation, and failure analysis expertise throughout your product lifecycle. As a single-source testing partner, we provide the specialized capabilities needed for successful medical device manufacturing and compliance requirements.
What is Medical Grade Polymer Testing at Element?
Medical Grade Polymer Testing delivers characterization of key properties to meet quality and performance standards. This testing is integral to device development, improvement, and failure analysis investigations, supporting the complete lifecycle of medical device manufacturing.
What Can Element Offer You For Medical Grade Polymer Testing?
Materials And Components We Test
Materials And Components We Test
We test water-soluble polymers, excipients, pre-filled syringe components, medical patches, and tissue adhesives. Our comprehensive capabilities include gel permeation chromatography of water-soluble polymers, gelatin bloom strength testing, and specialized evaluation of tissue adhesives. We support testing across Class I, II, and III medical devices with particular expertise in combination polymer/drug devices
Key Tests Offered
Key Tests Offered
Our testing includes material identification, thermal properties analysis, mechanical testing, and molecular weight determination. We provide specialized medical device testing including syringe break and glide force, particulate analysis, and medical patch adhesion. Additional capabilities include pre-filled syringe extrusion force testing and actuation force measurement.
In addition to standard polymer characterization, we have developed techniques and capabilities specific to pharmaceuticals and medical devices, including:
- Gel permeation chromatography (GPC) of water-soluble polymers/excipients for Molecular Weight (MW) and Molar Mass Distribution (MWD) determination
- Gelatin bloom strength
- Pre-filled syringe extrusion force
- Syringe break and glide force
- Particulate counting and identification
Development of custom testing programs
- 510(k) programs to compare medical devices to predicate devices
- Medical patch adhesion strength
- Actuation force
- Chemical exposure testing (e.g. cleaners and antimicrobials)
- Evaluation of tissue adhesives
Methods And Solutions Offered
Methods And Solutions Offered
We develop custom testing programs for pharmaceuticals and medical devices, supporting your specific requirements throughout the product lifecycle. Our services cover development, improvement, and failure analysis investigations, with specialized techniques for medical applications. We provide comprehensive 510(k) programs to compare medical devices to predicate devices.
Our medical-grade polymer test methods:
- Material identification
- Material thermal properties (Tg, Tm, thermal transitions in protein-based devices, residual cure)
- Filler content analysis
- Mechanical testing: Tensile, Compressive, Flexural, Density, Hardness, Melt Flow
- Morphology and elemental analysis
- Determination of crystal structure of drugs in combination polymer/drug devices
- Molecular Weight (MW) and Molar Mass Distribution (MWD) of polymers
Cutting-Edge Equipment We Use
Cutting-Edge Equipment We Use
Which Labs Offer This Service
Which Labs Offer This Service
Our 9,000-strong team operates from Life Sciences hubs across the world, providing global access to our expert capabilities. Find your nearest Life Sciences hub on our Locations Page.
Medical Device Development Expertise
Medical Device Development Expertise
Our polymer scientists bring specialized experience across Class I, II, and III devices, supporting your 510(k) programs and regulatory submissions. Element's highly qualified polymer experts have the expertise to help you improve and qualify your materials and products. We offer expertise in developing custom testing programs specific to medical device applications, with particular focus on combination polymer/drug devices.
Materials and components we test
Medical devices
- Pre-filled syringe components
- Medical patches
- Tissue adhesives
- Water-soluble polymers/excipients
- Class I, II, and III devices
Polymers and materials
- Water-soluble polymers
- Medical-grade polymers
- Gelatin-based materials
- Pharmaceutical excipients
Your Challenges, Our Solutions
Regulatory expertise delivered
Quality standards achieved
Development path optimized
Production testing simplified
Why Choose Element
Complete testing solution
Regulatory compliance
Medical device specialists
Advanced capabilities
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