JEMMDx

Successful diagnostics and Fem-Tech innovators with 25 + years of industry experience. We are a consultancy service uniquely focused on patient-centric diagnostics: Point of care tests, Consumer Diagnostics, and FemTech. In-depth knowledge and expertise in: Product Strategy and Messaging/ claims substantiation Clinical and Regulatory pathway development and clinical trial support Quality Management System (ISO 13485) implementation for global market support IVDR Pathway and DHF Gap analysis and remediation Regulatory submissions (UKCA, EU IVDR, FDA, WHO, PMDA etc) Studies/RWE: Regulatory, Post Launch, RWE and Usability, PMS reporting (PMPF) Stakeholder engagement/ advocacy – KOLs, NGOs, DHSC etc Medical communications- journal papers, White papers, conference symposia We offer an industry-experienced, pragmatic approach to deliver what is required For certification we work closely with the notified body to achieve this efficiently and quickly By simplifying the Path to Market we enable businesses from start-ups to established organisations to navigate complex regulatory, quality and clinical challenges . Engaging with healthcare providers and patients, we can enable actionable insights driving product design, development, launch and market development to enable life-changing Diagnostic and FemTech technologies successfully launch and improve people's lives.