About
Dr. Rafiq Muhammad
MBBS, MIHMEP, PhD · Physician and health-AI scientist. Clinical medicine, health AI research and regulatory evidence for medical devices.
A medical doctor with a PhD in artificial intelligence in healthcare from Karolinska Institutet and a master's in healthcare management, economics and policy from SDA Bocconi.
Fifteen years across clinical practice, humanitarian health programmes, academic research, a clinical research organisation and national health-system planning.
At Karolinska he built machine-learning decision support for patients with concurrent cardiovascular disease, kidney disease and diabetes, and a model predicting 30-day hospital readmission from electronic health records, with ten peer-reviewed publications.
As a real-world-evidence scientist at a Stockholm clinical research organisation he delivered registry and medical-record studies for health-sector and pharmaceutical clients.
He has drafted regulatory submission documents for medical devices for the US FDA, and built Device Evidence and Precedium.
Why this practice exists
Small AI device teams make their most expensive regulatory decisions — the code, the predicate, the study — before they can afford a regulatory department. The FDA’s own record already shows what comparable devices claimed and reported. Device Evidence reads it; Precedium applies it to one device at a time.
Device Evidence
The free public analysis behind every engagement: what the clearance summary of each AI-enabled device on the FDA’s list discloses, with the page, its predicate chain and its recalls.
Start with a free pathway brief
The first S1 brief for your device is free. A twenty-minute call is enough to start: what the device does, where you are, and the date you are working to.