What is Specialty Medical Device Development?
Specialty medical device development involves cutting-edge material science and therapeutic chemistries to improve human health and well-being. Due to the novelty of these devices, there is often little research or precedence on how to proceed with development. The materials in these devices can interact with the body in new and fascinating ways. Because of this, it is important that those developing such devices are able to understand and identify any risks from the new materials and therapies and to determine if they possess a danger to human health.
Specialty Medical Device Development at EKG Labs
At EKG Labs we regularly work with clients who are looking to develop new specialty medical devices that incorporate novel materials and therapies. We understand how to develop a research plan and how to investigate each component material to identify any potential impurities or degradants which may pose a health risk. EKG also knows how to prepare and submit data to the FDA as it relates specialty medical device development.