Start with intended use
Product claims, users and clinical context shape classification, risk, evidence and architecture. We make those dependencies visible early.
About Predetics
Regulatory consulting and software development for SaMD.
Predetics is a specialist Pharmadocx Consultants brand for teams developing Software as a Medical Device, software in a medical device and AI-enabled medical technologies.
Why we exist
Software and regulatory work should not be separate.
Medical device software cannot be developed in one lane and documented for regulators in another. Intended use affects architecture. Risk controls affect requirements and testing. Cybersecurity decisions affect the submission and post-market plan.
We bring these workstreams together. Our role may begin with pathway strategy, a Pre-Submission or an evidence gap review—or with architecture and implementation when the product itself needs work. The engagement is shaped around the actual device, team and market plan.
Predetics operates as a focused brand within Pharmadocx Consultants, drawing on its wider medical-device regulatory foundation while concentrating on software-intensive products.
How we work
How we approach the work.
Connect code to evidence
Requirements, hazards, architecture, controls and tests should support the claims made in the submission.
Be precise about uncertainty
Regulatory decisions belong to authorities. We give clear recommendations, assumptions and options without promising outcomes we do not control.
Build for what follows
A submission is a milestone, not the end. We consider maintainability, change control, cybersecurity and post-market responsibilities.
Tell us about your product.
We'll review where the product stands and explain which regulatory questions should be addressed first.