From Digital Health Idea to Market — Without Getting Lost in Regulations.
Regulatory documentation is the biggest bottleneck for digital health startups.
Regulatory in a Box gives you a complete, ready-to-implement system for FDA 510(k) and EU MDR compliance, so you can move faster, avoid costly delays, and focus on building your product.
Lean, reliable, sustainable.
Aligned with FDA 510(k), EU MDR, ISO 13485, IEC 62304, ISO 14971, and other key standards.
Products
510(k) in a box
A structured FDA 510(k) documentation framework designed for digital health and SaMD teams preparing regulatory submissions.
Provides the core documentation foundation, including software lifecycle, risk management, and cybersecurity documentation.
EU MDR in a box
A structured EU MDR Technical Documentation framework designed for digital health and SaMD companies preparing submissions.
Covers Annex II and III documentation requirements, including software, risk management, and usability documentation.
QMS in a box
A Quality Management System documentation framework for SaMD/digital health products aligned with ISO 13485.
Covers essential quality processes including design controls, CAPA, document control, and change management.
IEC 62304 in a box
A software lifecycle, verification, and validation documentation framework aligned with IEC 62304 and regulatory expectations.
Provides the core documentation structure required for software medical device regulatory compliance.
Standards & Frameworks
FDA 21 CFR Part 820 · EU MDR (2017/745) · ISO 13485 · IEC 62304 · ISO 14971 · IEC 62366 · FDA Cybersecurity Guidance
Need Hands-On Support Instead?
In addition to our documentation frameworks, we provide end-to-end regulatory consulting services for digital health and Software as a Medical Device (SaMD) products.
We can support you with:
- Complete FDA 510(k) and EU MDR submissions
- Development of software validation and lifecycle documentation
- ISO 13485 Quality Management System implementation
- Targeted regulatory guidance and document review
This option is ideal for brand new teams that want direct expert involvement rather than starting from scratch.
