We have over 20 years experience in the medical device industry providing Regulatory, Clinical and QA services, all under one roof.
Our vast experience will assist you in meeting specific technological and clinical requirements, complying with horizontal and vertical international standards as well as following the requirements of worldwide regulatory organizations, such as the FDA and the European Union (CE Mark). By becoming involved in the early stages of the development process, MedicSense minimizes the risk of potential re-engineering, thereby saving precious time and resources.
We have the expertise to guide you through the entire development process, from initial concept to regulatory plan, verification and validation, clinical studies, pre-marketing clearance and post-marketing compliance.
The services we provide will both allow you to begin marketing your product and ensure that you remain in compliance.
MedicSense is ISO9001:2008 Certified