Meridian 103.8 is a specialist consultancy that takes medical device, software and AI-as-a-medical-device companies from early development through regulatory clearance, commercial scale and capital — across Europe, the USA and Singapore.
Deep regulatory expertise combined with practical go-to-market and growth support — so the right product reaches the right market on a regulator-ready path.
We embed alongside founders and teams, translating regulatory approval into commercial traction at every stage.
We define the product and its regulator-ready route to market from the outset, mapping the EU, US and Singapore in parallel.
QMS, technical documentation and clinical evidence built to MDR/IVDR, FDA and HSA expectations — with SaMD and AI specifics baked in.
We streamline processes, documentation and portfolios to reduce risk and prepare for audit, partnership or acquisition.
We turn approval into revenue — go-to-market, investor readiness, diligence and non-dilutive grant funding.
Selected engagements across our focus regions. Each is added from a single content file, so the wall grows as the work does.
+ Engagements are anonymised at each client's request. Named references available under NDA.
What founders and regulatory leads say about working with Meridian 103.8.
A senior team spanning regulation, clinical, commercial and capital — with hands-on experience getting products to market across the EU, US and Singapore.
A monthly signal on regulation, market access and capital for medical device, SaMD and AIaMD teams. No noise.
Regulatory shifts, market-access playbooks and funding intelligence — written to be read here and shared straight to LinkedIn.
Tell us where you are on the journey — development, compliance, scale or capital — and we'll map the path from here.