FDA & MDR Submission Support

Whether you are pursuing FDA 510(k) clearance, De Novo classification, PMA, or CE marking, early design decisions made without regulatory awareness can create gaps that are costly to recover.

Moving fast is essential. But you can only move fast safely if you know what you’ll need later.

Missing traceability, incomplete risk files, undocumented design decisions, and untestable architectures often force costly rework that delays regulatory approvals.

We don’t front-load your project with premature documentation. Instead, we bring the full regulatory awareness into your earliest engineering decisions—so when formal design controls are needed, nothing has to be redone.

From design work to submission-ready documentation

One-stop access to multi-disciplinary expertise.

We structure your development process to match the appropriate regulatory expectations at every stage.

In early development, we keep documentation lean and focused on user needs, key hazards, and critical functional requirements. As feasibility is established, we increase the level of rigor – adding more structured documentation, stronger traceability, and formal configuration management and change controls, all within our ISO 13485-certified quality management system.

We identify hazards early and carry them forward through the design process in accordance with ISO 14971—even when the formal risk file is built later. This means no surprise gaps in your risk traceability when it’s time to submit.

We design testable architectures and produce clinical-quality prototypes from the start. Verification strategies, test protocols, and acceptance criteria are defined early—so evidence generation is built into the development process. As programs mature, we support formal validation activities by helping prepare production-equivalent devices, use-related documentation, and the engineering inputs needed for end-user or clinical studies.

When it’s time to formalize, we produce the engineering documentation your submission requires: system and subsystem requirements, architecture diagrams, risk analyses, verification protocols and reports, traceability matrices, and review records (to name a few)—structured to support your 510(k), De Novo, PMA, or MDR technical file.

Our embedded software, firmware libraries, and data infrastructure have been through the regulatory process before. When we build on proven components, we know they will hold up under verification and submission scrutiny—which means fewer surprises, less rework, and a faster path to clearance.

We develop under our certified ISO 13485 quality management system, so development proceeds under a compliant framework from the start, even if you don’t have your own certified QMS in place. Then when the time is right, you can bring everything into your own system, with confidence that documents and records were developed correctly all along.

Result-based business model

Cash efficiency is a “do or die” proposition for any early stage company, and hourly-priced projects can quickly lead to cost and time overruns.

Our pricing is based on results, giving you the predictability you need to plan your budget and meet your funding milestones with confidence.

And with direct access to our project management system, you have real-time visibility into our progress so you always know where you are.

You pay for: Milestones completed

You don’t pay for: Our time

design for success

From napkin sketch to commercially-viable product, we take a holistic approach to product development, addressing all the required aspects for your device to be successful:

Technical
Ensuring the device can perform as required to deliver the intended clinical results

Usability
Ensuring the device can be operated in the intended clinical setting

Standards
Ensuring the design and development process is documented in compliance with ISO 13485:2016 and that the design meets the requirements imposed by relevant regulatory standards

Manufacturability
Ensuring manufacturing is feasible within your business case assumptions and identifying qualified suppliers and manufacturing partners

Financial
Optimizing device cost of goods sold (COGS)

IDEA

Research

Design & Development

Pre-clinical studies

Verification & Validation

Transfer to Manufacturing

CE & FDA Submissions

Our top team
is now
your team.

We are a small firm where everyone is an expert in their field, everyone is working hands-on with a client, and everyone is invested in your success.

Turn your sketch into reality.