We provide medical testing and regulatory support for a broad Variety Of devices and substances across the health care industry. Working to ISO, ASTM and FDA standards and novel methodologies with justification once the standards are not adequate, we supply a one-stop solution to chemical and mechanical testing, consultancy service for regulatory submissions, and materials characterization. Our complete offering is valuable to our customers as we provide evaluation and interpretation of test results, and not just the numbers. Analytical interpretation and rationale support makes regulatory submissions stronger once you have the ability to clearly demonstrate why you chose your method and show a complete comprehension of what the results mean for your devices and the end users.
As materials science specialists we understand that problems Inevitably come down to the substance degree. Pinpointing when the problem happens, and how to fix it, isn’t always simple. Informed testing, and years of experience, allows us to examine any medical apparatus problems and challenges to troubleshoot issues. The identical experience is applied to medical device material characterization and regulatory testing. Devices are complex in geometry, chemistry and material and the criteria often have to be considered carefully to be certain that the tests we perform give us the truest evaluation of medical devices in use. This strategy is exactly what we at Lucid eon have built our reputation on for encouraging the successful entry of medical devices to FDA and other regulatory bodies.
Our team comes from diverse backgrounds and works closely together to cross fertilize experience for any specific application. In addition to medical device testing specialists with industry experience, we are composed of surface science specialists, metallurgists, ceramics and polymer specialists, mechanical engineers, materials authorities e.g., on hydroxyapatite and a number of other disciplines.Our materials knowledge gives us excellent understanding of their behaviour and performance. Your product or substance could benefit from the many services we provide, such as.
- Biocompatibility – make sure your products are biocompatible and prevent unnecessary in vivo testing
- Quality Control Testing – guarantee batch consistency through present or Lucid eon developed protocols
- Powder Processing Consultancy – troubleshoot and optimize processes to produce better returns, stability and overall performance including grinding, foaming and rheology
- Regulatory Submission Support – create accurate and complete information to submit to FDA and other authorities
- Cleanliness Validation – develop protocols, confirm cleanliness, identify contaminants and comprehend the significance of changes to your production process
- Wear and Mechanical Testing – test the durability and robustness of orthopedic implants and other medical devices
- Failure Analysis – identify root causes, resolve failures and prevent re-occurrence