Grassstone

WHAT WE DOThe medical devices market is growing exponentially throughout the world. Device manufacturers tend to shape medical spending by bringing new products to market through emergency authorizations, quickly repurposing manufacturing lines, and modifying or upgrading old devices. Eventually, the regulatory and quality consulting market receive... d a pivotal position, driving product approval for the manufacturers. We understand the small-mid-size philosophy and the work they need to accomplish with constrained resources. Medical startup goes through tremendous challenges with regulatory and quality issues. FDA clearance is the most challenging in terms of time, expense, and resources. Grassstone has committed to help startups and small to mid-sized firms to help regulatory and quality needs.THE TECHNICAL STUFFWhether you're just starting or looking to restructure, we've got you covered. Our mantra is: analyze, identify, advise, execute. Our mission is to create relationships, not transactions. We promise that we'll be there as questions or issues arise every step of the way. OUR EXPERTISEWe're a group of medical device quality and regulatory experts and strategists who thrive on sharing our experience and knowledge to help you succeed in your device approvals. Our expertise proves that clear communication and expert collaboration with regulatory bodies boost your bottom line of pre-market and postmarket device success. Our services include medical device premarket notification (510k) and premarket approvals (PMA) processes, risk management consulting, establishing and maintaining quality management systems, help conducting pre-sub meetings with FDA or other appropriate regulatory bodies, providing feedback support, help in conducting stage I and Stage II audits, and achieving final approvals for device marketing.Read More