For Pre-Market Startups & Scaleups

SaMD Greenfield Development

Building a SaMD from scratch means two simultaneous challenges: writing the software and satisfying the regulator. P4SaMD makes them the same phase.

Trusted by

healthcare organizations worldwide

The Problem

The 3–6 month documentation sprint that kills launch momentum.

Engineering and documentation run on disconnected timelines: by the time quality teams start documenting, traceability is already broken and the system has changed. The result is a 3 to 6 month documentation sprint that delays revenue and pressures the quality team to reconstruct artifacts that were never captured incrementally.

The Need

Compliance as a continuous output of normal engineering work.

A framework that eliminates friction between engineering speed and regulatory requirements, integrating compliance directly into the SDLC so teams build software that's audit-ready at every increment, not just at the finish line.

The Solution

From first commit to compliant MVP, in one motion.

P4SaMD enables continuous compliance orchestration by monitoring the development environment in real time. As code evolves, quality documentation is automatically synchronized.

The team builds their product. P4SaMD builds the regulatory file alongside it, making audit-readiness the default output of normal engineering work.

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Case Study

Case Study // Digital Health Startup

"A Digital Health startup focused on personalized metabolic health management and clinical support platforms, combining medical expertise with advanced technology."

Scope

✓API developed on P4SaMD connected with a regional EHR
✓Full greenfield SaMD development with continuous compliance orchestration from day one
✓Automated traceability matrix maintained with zero manual effort throughout development
✓Complete Design History File generated continuously alongside engineering work

Measured outcomes from the field.

1 Month

from zero to a fully compliant MVP on sovereign infrastructure

manual effort required for traceability matrix maintenance throughout development

100%

Compliance-by-Design: eliminating the typical 3–6 month documentation sprint before launch

Capabilities Involved

The P4SaMD capabilities that power this use case.

01 — SDLC

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