ChemRisk^® can provide valuable assistance with medical device development by addressing the often changing landscape of expectations set forth by regulatory agencies. We help manufacturers determine appropriate classifications for their devices, and identify safety, efficacy, and risk/benefit issues. We can also help our clients to establish compliance systems for post-market reporting, develop and maintain device registries, and manage regulatory and public issues in the face of recalls. We specialize in recognizing and characterizing the risks posed by chemical components of devices that may degrade or be released over time.

As such, our firm was chosen for projects as varied as exploring the possible presence of mercury in certain preparations and medical devices, assessing the possibility of compounds leaching from silicone breast implants, examining phthalates released from the tubing of certain fluid delivery pumps, assessing silicon levels in the powder linings of drug delivery injection devices, and evaluating a host of other trace chemicals allegedly released from medical devices.