Our team of expert consultants has extensive hands-on experience in navigating the complex landscape of managing regulatory submissions for medical software products in the EU and US markets.
Successful regulatory submissions require manufacturers to stay up to date with the latest regulations, guidances, standards, and best practices which can be time consuming and difficult to manage. True North covers the regulatory landscape of both the United States and the European Union, providing you with a holistic view of the changing requirements. We not only keep you informed about changes but also provide valuable insights and analysis to help you understand the implications of new regulations on your products, QMS, and overall compliance strategies.
We also understand the evolving nature of the IT industry and the medical device regulations. By combining our legacy systems expertise with our proficiency in emerging technologies (e.g. AI and machine learning), we help you anticipate regulatory challenges and adapt to changing requirements. We provide insights and guidance to incorporate compliance measures early in the development process, saving you time, resources, and potential roadblocks in the future.
From initial strategy to final submission, we provide end-to-end solutions to support your compliance journey. The entirety of our service provides you with comprehensive regulatory consulting, including assistance with 510(k) submissions, CE marking, technical documentation, risk assessments, and more. Our collaborative approach ensures that your submission is accurate, complete, meets all the necessary regulatory requirements and is optimized for your unique business.
By leveraging our expertise you can make informed decisions and stay ahead of the curve.
Contact us today to learn more about our regulatory submission services.
