FDA 510(k) in a box
A complete set of FDA 510(k) submission documents for SaMD, guiding digital health teams through regulatory preparation.
Includes
- All documents required for an FDA 510(k) submission
- Editable Word and PDF templates (fill-in-the-blank)
- Built-in questions and guidance notes in each document
- Software V&V, risk assessment and cybersecurity documentation as required for FDA review
Standards & Frameworks
FDA 510(k), IEC 62304, ISO 14971, FDA Cybersecurity guidance
EU MDR in a box
A complete set of EU MDR Technical Documentation templates guiding teams through regulatory preparation.
Includes
- EU MDR Annex II & III Technical Documentation templates
- Editable Word and PDF templates (fill-in-the-blank)
- Guidance notes to help align content with EU MDR expectations
- Software, risk, and usability documentation for the technical dossier
Standards & Frameworks
EU MDR (2017/745), ISO 14971, IEC 62304
QMS in a box
A practical Quality Management System template set designed for software-focused medical device organizations.
Includes
- ISO 13485-aligned QMS and SOP templates
- Editable Word and PDF documents with guided sections
- Design controls, document control, CAPA, and change management
- Embedded guidance to adapt the QMS to your organization
Standards & Frameworks
ISO 13485, ISO 14971, IEC 62304 fit for FDA and EU requirements
IEC 62304 in a box
A documentation system for software lifecycle, verification, and validation, suitable for SaMD and digital health products.
Includes
- IEC 62304-aligned software lifecycle documentation
- Software verification & validation templates for any type of product
- Configuration and software change management documents
- Fill-in-the-blank Word and PDF files with built-in guidance
Standards & Frameworks
IEC 62304, ISO 14971, IEC 62366 fit for FDA and EU requirements
Need Hands-On Support Instead?
In addition to our template packages, 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 teams that want direct expert involvement rather than working from templates.
