BoardSnap is an iOS app that captures the whiteboard-heavy design and regulatory work medical device teams do — risk analysis, design verification, 510(k) strategy — and turns it into structured, documented output you can build a DHF from.
Medical device development is documentation-intensive by necessity. Every design decision, every risk analysis, every regulatory strategy discussion needs to be traceable. But the real thinking happens at whiteboards — design reviews, FMEA sessions, verification planning — and the whiteboard rarely makes it into the Design History File intact.
BoardSnap gives device teams a systematic way to capture whiteboard output as documentation-ready text. Snap the risk analysis diagram, the design verification test matrix, the use error analysis flow. BoardSnap AI reads the structure and returns a written summary that becomes the starting artifact for your technical file.
For device companies managing multiple product families or development programs, Projects keep each program's documentation history separate. Design files for an orthopedic implant shouldn't mix with a diagnostic imaging program. Pin the applicable standards (ISO 14971, IEC 62304, etc.) as context so every summary reflects the right regulatory framework.
Map hazards, hazardous situations, and harms on the board with the FMEA structure. Draw the risk estimation grid. Snap it. The summary becomes the first artifact of your risk management file — structured, traceable, and ready for your RA team to formalize.
Lay out the V&V test matrix on the board: design inputs, test methods, acceptance criteria, responsible party. Snap it. The structured summary gives your quality team the V&V plan draft before the design review closes.
Map the regulatory pathway, predicate devices, substantial equivalence argument, required studies. Draw the submission timeline. Snap it. The summary gives regulatory affairs the submission strategy brief aligned with what the team agreed.
Walk through the use scenario on the board: user profiles, use environment, critical tasks, failure modes, mitigations. Snap it. The summary becomes the use-related risk analysis starting point for your human factors engineering file.
Sketch the PMS framework: data sources, signal detection criteria, periodic review cadence, CAPA triggers. Snap it. The structured output becomes your PMS plan draft — and updates to the plan get tracked as new snaps in the same project.
VisionKit runs on-device — no external data transfer during perspective correction. AI summarization sends content to BoardSnap's API. For boards containing design specifications, clinical data, or confidential device information, review your IP protection and information security policies. BoardSnap-generated summaries are useful as working documents and first drafts; they do not replace the formal QMS documentation process or regulatory review.
BoardSnap summaries are starting-point artifacts — a structured capture of what was discussed and agreed. They need to go through your QMS review process before becoming formal DHF records. Think of them as the raw material your RA/QA team formalizes, not the final document.
Yes. Tabular structures, grids, and matrices read well. BoardSnap AI extracts the rows, columns, and content in structured prose — not a perfect table reproduction, but a faithful written description of the FMEA content.
Each product family gets its own project in BoardSnap. Board history, pinned standards references, and context are isolated per project. Nothing from one product's development history appears in another.
Yes. Pre-inspection planning sessions — what the auditors will look for, where the gaps are, what to prepare — work well as whiteboard sessions and BoardSnap captures. The summary gives your quality team a structured pre-audit action plan.
Free: one project, 30 boards. Pro: $9.99/month or $69.99/year for unlimited everything plus AI chat.
Snap a board. Get a clean summary and action plan tied to your team.