Get clarity fast. Whether you bring us a pitch deck, a concept note, or an early prototype, we map your product to the correct regulatory pathway in plain language, saving you weeks of uncertainty and preventing costly missteps before fundraising or development begins.

Includes:

• FDA/Health Canada/EU classification

• SaMD/IMDRF risk category

• Predicate device or reference standard analysis for FDA 510(k) submissions

• Early red flags for AI/ML features

• Regulatory roadmap with realistic timelines

Perfect for AI diagnostics, CDS tools, ML-enabled imaging analysis, DTx, and cloud-connected software.

Your pre-QMS blueprint, right-sized for startups. Most early-stage teams don’t need a full QMS, but they do need structure. We build a simple, founder-friendly compliance plan that connects:

• What you're building

• What regulators expect (FDA, Health Canada, EU MDR/IVDR, UKCA)

• What risks matter

• What documentation protects your product

• Which controls you need now vs later

This avoids premature investment in enterprise QMS systems and helps you build only what’s appropriate for your maturity level.

AI is where strong products often hit regulatory friction. The FDA is still finalizing guidance on how to evaluate continuously learning models, adaptive algorithms, and ML-enabled decision support. We help you navigate this evolving landscape with confidence.

We help you:

• Frame AI features in ways that align with current FDA thinking

• Build evidence strategies for model performance, robustness, and bias

• Create documentation that speaks FDA and IMDRF language

• Avoid accidental up-classification or additional scrutiny

• Understand and apply Good Machine Learning Practice (GMLP)

This is ideal for computer vision imaging tools, predictive analytics models, triage algorithms, AI radiology tools, real-time inference engines, and other ML-enabled devices.

Only what you need, nothing you don’t. We create high-quality, audit-ready documentation built for modern software teams, not legacy device manufacturers.

Support includes:

• Software requirements & architecture (IEC 62304)

• Risk management (ISO 14971)

• Traceability matrices (requirements → risks → verification)

• Design documentation for AI/ML and SaMD

• Clinical claims & intended use alignment

• Evidence plans for algorithm performance testing

• ISO 42001 / AI governance guidance

• Labeling, UX risk factors, and IFU review

You get pragmatic, lean documents, not bloated templates copied from hardware devices.

When you're ready to file, we prepare and refine everything you need for a smooth review cycle.

Support includes:

• FDA 510(k) submission drafting

• Health Canada MDL applications

• EU MDR / IVDR technical documentation

• Pre-submission meeting packages

• AI/ML evidence packages and model performance documentation

• Responses to regulator questions

• Clinical evaluation strategies (SaMD)

Your early investments in clarity and documentation pay off here, producing faster, cleaner submissions.

Some teams need ongoing guidance but aren’t ready for a full-time regulatory hire. We act as your fractional regulatory lead, supporting you through rapid development cycles.

We provide:

• Design control guidance during sprints

• Review of new features (especially AI-related changes)

• Documentation oversight and continuous improvement

• Risk assessments for product decisions

• Support for investor diligence and board communication

You get continuity, clarity, and expertise, without the overhead of a full-time RA role.