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How do you extend life without unwanted side effects?

Medical Device

How do I show that my cardiovascular stent is safe from nickel leaching? How do I determine why our mapping catheter has failed? How to I prove that my hip implant is clean after manufacturing? How do I determine that the container system does not impact the performance of my IVD? How do I show that the surface of my ophthalmic device will not cause irritation? EAG scientists solve difficult medical device problems, advance product development, and provide valuable data for successful PMA and 510(k) submissions. By utilizing our unique combination of expertise in materials, electronics and life sciences, EAG empowers medical device companies to create new ways to repair and heal the body as well as improve quality of life for the patient.

Product Innovation & Improvement

EAG scientists support medical device innovation from selecting the raw or starting materials to assessing a new manufacturing process. We help device clients seeking to understand their surfaces and materials in order to obtain the maximum amount of information possible for FDA submissions. This may include surface modifications to enhance biocompatibility, materials purity and surface cleanliness.

Investigation & Troubleshooting

When failures or problems occur, the scientists at EAG Laboratories design investigations from basic characterizations to extended troubleshooting projects. Our expert metallurgists, polymer and coating chemists, electronic engineers, pharmaceutical scientists have years of experience finding the root cause of problems. From a failure analysis debug to a polymer degradation project, EAG offers deep expertise in medical device problem-solving.

Quality Assurance

Our laboratories provide valuable support for QA/QC projects. We have been ISO 17025 certified across many of our materials characterization services since 2009, with specific methods audited and inspected by major device manufacturers. EAG also provides GLP/GMP support for extractables/leachables programs. Our microelectronics test and engineering laboratories also monitor IC components of electronic devices.

Regulatory Compliance

EAG scientists understand the types of material characteristics needed as data to support US and OUS submissions, helping our clients bring innovative, safe and effective devices to patients. The regulated studies are designed under Industry Standards and Notified Body guidance documents (ISO 10993 parts 18 and 19) to help support the overall biological evaluation of medical devices. These regulated studies are performed in our ISO 17025 and ISO 9001:2008 certified laboratories, for Class II and III devices supporting therapies in Cardio/Peripheral Vascular, Ophthalmic, Orthopedic, Wound-Healing, Neurovascular, ENT, Urological, and Diabetes Care.

Manufacturing & Supply Chain Support

From qualifying incoming raw materials to confirming ultra-clean manufacturing, EAG’s surface, organic and microscopic analyses play an important role in supply chain support for the device sector. Areas of particular expertise include contamination control during manufacturing, alloy identification, semiconductor analysis, residual solvent analysis and surface cleanliness.

Consulting/Litigation

EAG’s consulting and litigation support services have helped companies resolve difficult issues with product liability and intellectual property challenges. Our litigation support services include analytical testing, interpretation of technical data, critical review of data, expert opinions and deposition/trial testimony.