Bringing innovative medical device technology 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 device testing needs, from start-up ventures to established manufacturers.
We specialize in orthopedic, cardiovascular, diagnostic and therapeutic devices, and support every stage of medical device testing from test protocol development and prototype/feasibility trials to testing and consultation for 510(k) and other regulatory submissions.
Element provides a comprehensive suite of medical device testing and support services including:
- Mechanical & materials characterization
- Product regulatory testing
- Microbiological evaluation
- Chemical characterization, extractables & leachables
- Reprocessing validation and instrument evaluation
- Electrical safety testing
- Wireless coexistence
- Regulatory submission services and technical consulting
Everything we do is designed to help our customers develop better products, get them to market on time, save time and money, and minimize the risk to their business.