Formly

Formly is a regulatory partner specifically designed for medical device companies aiming to accelerate market access across major global jurisdictions. The platform integrates three core components: a team of senior regulatory experts with hands-on experience at the U.S. Food and Drug Administration (FDA), a purpose-built electronic quality management system (eQMS), and AI agents trained on live regulatory updates. This combination allows companies to either delegate the entire submission process to Formly’s experts or use the platform’s tools independently. Formly’s expert team does not merely provide advisory services; they actively handle submissions for FDA 510(k), premarket approval (PMA), EU Medical Device Regulation (MDR) technical documentation, UKCA marking, and MDSAP (Medical Device Single Audit Program) certifications. By assigning former FDA reviewers and notified body specialists to each project, the service ensures that submission documents meet the specific expectations of regulators, reducing the risk of deficiency letters and delays. The integrated eQMS is built with medical device workflows in mind, covering design controls, risk management (ISO 14971), clinical evaluation (MEDDEV 2.7/1 for EU MDR), post-market surveillance, and CAPA (corrective and preventive actions). It automates document version control, audit trails, and regulatory reporting, enabling teams to maintain compliance without manual overhead. Templates and checklists are pre-configured to align with FDA’s 21 CFR 820, ISO 13485:2016, and EU MDR Annex IX requirements, saving weeks of setup time. Formly’s AI agents continuously monitor regulatory changes from sources like FDA guidance documents, EU Medical Device Coordination Group (MDCG) updates, and international standards updates. They