Case Study: Advanced Oncotherapy achieves and sustains ISO compliance and FDA validation with Autodesk Fusion Lifecycle

How Advanced Oncotherapy is using PLM to achieve and sustain ISO compliance and FDA validation

Advanced Oncotherapy, a designer of the LIGHT proton beam therapy system with sites in London, Geneva and Syracuse, needed to move from R&D to regulated manufacturing while minimizing paperwork and achieving ISO 13485 and FDA compliance. Their legacy PLM couldn’t integrate PDM, CAD and ERP data or support enterprise-wide processes, risking manual errors and regulatory gaps.

They implemented Autodesk Fusion Lifecycle with consulting support from D2M3, migrating product data and going live in three months. The cloud-based PLM expanded from six legacy users to 60+ active users, now managing audits, change control, supplier audits, non-conformities and more, enabling secure global collaboration, a single source for compliance data, and planned integration with Epicor ERP to automate supplier and part workflows.

Advanced Oncotherapy

Neil Barker

Quality Manager