What is SaMD in a Box?
SaMD in a Box provides structured regulatory documentation templates for digital health and Software as a Medical Device (SaMD) products. Templates are editable, fill-in-the-blank Word and PDF files with embedded guidance.
Are these templates suitable for both FDA and EU MDR?
Yes. We offer separate packages for FDA 510(k) submissions and EU MDR Technical Documentation, plus standalone packages for ISO 13485 QMS and IEC 62304 software lifecycle documentation.
Do you guarantee FDA clearance or CE marking?
No. Regulatory outcomes depend on your device, evidence, and execution. Our templates help you prepare documentation, but they do not guarantee approval or certification.
Is this legal or regulatory advice?
No. SaMD in a Box provides documentation templates and general guidance notes. It is not legal advice or a substitute for professional regulatory counsel.
What file formats do I receive?
All packages include editable Word and PDF documents.
Are the documents “fill in the blanks”?
Yes. Templates are structured with sections to complete, plus embedded questions and guidance notes to help you tailor content to your product and organization.
Can I use the templates for AI/ML SaMD products?
Yes, with appropriate adaptation. AI/ML products may require additional considerations depending on claims, risk, data, and regulatory strategy. We can provide consultation for AI/ML enabled SaMD product submissions.
Do you include eSTAR files for FDA 510(k)?
No. The FDA 510(k) package provides the required submission documents as editable templates. You can use the completed content to prepare your final submission format.
Does the FDA 510(k) package include software validation and cybersecurity?
Yes, at the level typically expected for an FDA 510(k) submission, including software verification/validation documentation, risk management, and cybersecurity assessment templates.
Does the EU MDR package include an ISO 13485 QMS?
No. The EU MDR package focuses on Technical Documentation (Annex II & III). QMS templates are provided separately in the ISO 13485 QMS in a Box package.
What’s the difference between “FDA 510(k) in a Box” and “Software Validation & Verification in a Box”?
FDA 510(k) in a Box includes software documentation needed for the submission. Software Validation & Verification in a Box provides a deeper, standalone IEC 62304-aligned lifecycle documentation system (including change/configuration management).
What’s the difference between “QMS in a Box” and “Software Validation & Verification in a Box”?
QMS in a Box is an organization-level ISO 13485 quality system (SOPs, CAPA, document control, audits, etc.). Software Validation & Verification in a Box is a software lifecycle documentation system aligned with IEC 62304.
Can I purchase one package now and add others later?
Yes. Many teams start with one package (e.g., FDA or EU MDR) and add software lifecycle or QMS templates as their regulatory needs grow.
Do you provide consulting support?
Yes. We can support teams with document review, submission preparation, and tailored regulatory consulting depending on needs and availability.
Will you customize the templates for my product?
Template packages are designed for self-serve use. Customization and hands-on support are available through consulting.
Who are these packages best for?
Digital health and SaMD teams who need structured documentation and guidance—especially startups or teams without deep in-house regulatory experience.
Who are these packages not for?
Teams seeking legal advice, guaranteed outcomes, or “one-click” compliance. Also not intended for PMA-only pathways or products requiring highly specialized regulatory strategies without expert involvement.
How do I know which package I need?
If you’re preparing an FDA submission, start with FDA 510(k) in a Box. If you’re preparing EU documentation, start with EU MDR in a Box. If your main gap is software lifecycle documentation, choose Software Validation & Verification in a Box. If you need organizational procedures and audit readiness, choose QMS in a Box.
How do I get started?
Use the Request Access or Contact page to reach out, and we’ll guide you to the right package and next steps.