Product Safety & Regulatory Support

Medical Devices

ENVIRON provides support to the medical device industry in all aspects of the development and regulation of medical devices—from design of pre-clinical and clinical testing through post-marketing surveillance. In addition to our work for individual companies, we have conducted studies under the joint sponsorship of regulatory authorities and industry trade associations in order to develop data critical to science-based decision making and standard setting.

Our scientists help clients to determine the likely regulatory pathway for their products and to develop the safety and efficacy data needed for marketing approval. We are also adept at addressing questions that arise after devices are marketed. ENVIRON scientists have extensive experience applying risk assessment methodologies to questions regarding the safety of medical devices and their components under actual conditions of use.

Clients also rely on ENVIRON to address recent regulatory developments that may place new demands on the performance of both industry and regulatory scientists to ensure that innovative medical products reach the marketplace quickly.