Formly

Formly revolutionizes the way startups and established companies approach medical device certification in the European Union and the United States. By combining expert regulatory guidance with advanced AI technology, Formly ensures that your medical device meets all necessary compliance standards efficiently and effectively. The platform's AI copilot assists in creating audit-proof technical documentation, significantly reducing the time and stress associated with interpreting complex standards and guidance documents. With features like the Quality Management System (QMS) that is fully ISO 13485 compliant, Formly eliminates the need for expensive templates and workshops, offering a streamlined solution for document approval and lifecycle management. Additionally, Formly's AI-generated MDR compliant documentation simplifies the creation of complex documents, making the certification process faster and more straightforward. Whether you're dealing with software only devices, hardware, or devices classified as I, IIa, IIb, or III, Formly scales to meet your needs, ensuring that your focus remains on bringing your product to market rather than navigating compliance challenges. With Formly, medical device certification becomes a manageable, efficient process, supported by a team of regulatory experts and cutting-edge AI technology.