Consulting

At EAG Life Sciences we help medical device companies navigate the complex medical device process by providing comprehensive chemical and physical testing services. We provide testing to support PMA and 510(k) applications, and can provide non-regulatory research and development services to support broader product development goals.

Medical Device Development Services

We provide comprehensive testing to support medical device development. We have in-depth expertise in both chemical and physical testing. Our scientists are experts in the analysis of complex matrices like polymers and composite materials and are adept at working in a regulatory environment.

Our analytical services include:

• Medical Device Chemical Analysis
• Medical Device Physical Analysis
• Failure Analysis and Problem Solving

Material Selection and Testing

Often the key to a successful medical device is the proper selection of materials. We can help you screen materials and components to see which would work best to achieve your product development goals. We can test the chemical properties of the materials and components to ensure there are no unwanted interactions between your device's components. Additionally, we can also test your API (Active Pharmaceutical Ingredient) with various candidate materials to examine potential extractable and leachable profiles. We can also test the physical properties of candidate materials to ensure your device can withstand the rigors of expected use.

Deformulation

Deformulation is an important tool for product development. It can deliver valuable insight into a competitor's product, develop a competing product or support a patent infringement case. Our organization has been providing comprehensive deformulation services for over 50 years and has experience working with products comprised of polymers, coatings, metals, ceramics and composite materials. In addition, we can provide expert testimony in a legal environment to support any patent infringement claims.

Marketing Claim Validation and Product Comparision Testing

Having a marketing claim validated by an independent third party is a valuable tool to win market share and grow new business. Clients chose to work with us to validate their marketing claims because of our experience, reputation as an independent third party and confidence that their data will kept confidential. Our technical affairs team will work directly with your R&D and marketing team to understand your product and to develop an appropriate study to demonstrate your products capabilities. Additionally, clients come to us to refute a competitor's claim. Depending on your needs we can perform a side by side comparison or simply analyze the attribute of interest in your competitor's device. EAG Life Sciences is also experienced assisting its client's in the legal arena. We have acted as expert witnesses in several cases and have provided depositions and courtroom statements.

For examples of our medical device development capabilities, please visit our Case Studies!