Bringing innovative medical products to the marketplace is a high‐risk venture. That’s why Element strives to provide absolute testing certainty by delivering accurate and reliable results for our clients’ medical product testing needs, from small, start-up ventures to large, established manufacturers.
Understanding the urgency of compressing product development cycle time helps to get your product to market faster. Your intellectual property is secure, and any test methods or technology we develop remains within your ownership. We understand the commercial demands on your time, so offering flexibility and efficiency is important to us.
The Element advantage
Our Engaged Experts work closely with customers to support them at every stage of their product lifecycle, from initial concept development to prototype manufacturing, process and release test method development and implementation.
Element has a proud history supporting customers to introduce new patented products and processes to the dynamic medical device industry. With a clear understanding of your markets, regulations, and challenges, we utilize our expertise and experience to help reduce your product development cycle-time and improve the speed of innovation.
We offer a full range of medical device testing, including:
- Medical device prototype design
- Materials selection
- Product and process development/combination products development
- Equipment design and medical device fabrication
- Custom polymer synthesis
- Failure analysis
- Regulation/equivalency testing
For more information about our medical product testing or to request a quote, contact us today.
Element offers the most comprehensive range of materials and product qualification testing services for the medical device industry.
Medical Device Product Development and Prototyping
Element’s medical device product development services enable safe and quality products to reach the market faster.
Medical Adhesive Testing
Our medical adhesive testing ensures quality is maintained throughout the lifecycle of a product, mitigating risk to patients and your business.
We offer analytical testing of medical and combination devices; ensuring product performance and regulatory compliance.
Medical Grade Polymer Testing
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.
Successful FDA 510(k) submissions are critical to your market success. Incomplete or inaccurate submissions can lead to failure and may delay your product launch.
Polymeric Failure Analysis
Failure analysis of polymer-based medical devices is critical to guarantee that process or material improvements can be made to prevent repeated failures.