We assist with developing design and development procedures so that you can implement a robust design control process during the entire product life cycle. Leveraging the technical backgrounds of our lawyers and regulatory science professionals, we provide global premarket assistance for medical devices and in vitro diagnostics. From start to finish, we work with you to seek formal product designation determinations by governing bodies; to determine the appropriate classification of your medical device; to help develop preclinical and clinical study plans; and to draft applications for human clinical studies.
