MedicSense is a Clinical, Regulatory Affairs and Quality Assurance consultancy firm serving the Medical Device Industry
We act also as an In-Country Israeli Registration Holder (IRH)
MedicSense, an IQVIA business, has 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 ISO13485:2016 certified
MedicSense was established to assist companies to contend with regulatory issues. When you work with MedicSense you can rest assured that our creative and innovative solutions have helped numerous companies of all sizes to both receive clearance for marketing their products and to stay in compliance
Our strengths are based on our extensive R&D, engineering, techno-regulatory background and experience with a wide range of medical device technologies. We know how to get products past the regulatory hurdles by providing pragmatic solutions. We understand the needs of the vibrant high tech medical device industry and the dynamic regulatory environment.