Reg in a Box was created to make regulatory documentation more approachable for digital health and Software as a Medical Device (SaMD) teams.
If you’re building a medical software product, you quickly realize that regulatory documentation becomes a major part of the journey. For clinicians and software developers, regulatory and quality requirements are often unfamiliar domains that must be learned alongside building the product itself. Understanding what to document, how to structure it, and how it all connects to FDA and EU MDR requirements can take months of work — especially without a clear starting point.
We created Reg in a Box to provide that starting point.
Where This Comes From
Reg in a Box is based on our experience developing Parky at h2o Therapeutics, a Software as a Medical Device designed for neurological assessment.
As part of bringing Parky through regulatory clearance, we built a complete quality and regulatory documentation system from the ground up. This included successfully achieving:
- FDA 510(k) clearance
- EU MDR (Regulation (EU) 2017/745) compliance
- ISO 13485 Quality Management System certification
Along the way, we developed and implemented documentation aligned with key regulatory standards, including IEC 62304 for software lifecycle processes, ISO 14971 for risk management, and IEC 62366 for usability engineering.
We experienced firsthand how much time and effort it takes to build this documentation structure — especially for teams whose primary expertise is in medicine or software rather than regulatory affairs — and how difficult it can be to know where to begin.
Why We Built Reg in a Box
Reg in a Box exists to help other teams avoid starting from scratch.
The frameworks we provide reflect the structure, organization, and regulatory alignment we developed during our own clearance process. They are delivered as fully editable Word and PDF documents, so your team can adapt them to your product, your processes, and your regulatory strategy.
Our goal is not to replace your regulatory expertise, but to give you a clear and practical foundation that helps you move forward with confidence.
Who It’s For
Reg in a Box is designed for:
- Digital health startups
- SaMD founders and product teams
- Quality and regulatory professionals
- Teams preparing for FDA 510(k) submissions
- Organizations building ISO 13485 Quality Management Systems
- Companies preparing EU MDR Technical Documentation
Our Approach
All Reg in a Box frameworks are aligned with the regulatory and quality standards commonly required for digital health and SaMD products, including:
- FDA 21 CFR Part 820
- EU MDR (Regulation (EU) 2017/745)
- ISO 13485
- IEC 62304
- ISO 14971
- IEC 62366
- FDA Cybersecurity Guidance
These frameworks are designed to give your team a structured starting point, while allowing full flexibility to implement and adapt them within your own organization.
Reg in a Box reflects what we built and learned while navigating FDA clearance, EU MDR compliance, and ISO 13485 certification ourselves. We hope it helps make the regulatory process clearer and more manageable for your team as well.