Why ApprovaDoc exists
Small medical device teams have been stuck with a bad choice for too long: track SOP training in spreadsheets and hope nothing falls through the cracks, or buy an enterprise quality management system that costs more than your entire product budget and takes months to configure.
The problem we kept seeing
We built ApprovaDoc because we kept running into the same problem: a small team preparing for an ISO 13485 audit, scrambling to prove that SOPs were properly reviewed, approved, and acknowledged by the right people. The evidence was scattered across email threads, shared drives, and spreadsheets that no one fully trusted.
The enterprise platforms solved this — but at a price and complexity level that made no sense for a team of fifteen. MasterControl and Veeva Vault are excellent products for large organizations with dedicated quality teams. They are not built for a startup with three engineers and a part-time QA lead.
ApprovaDoc exists to fill that gap. It handles the SOP lifecycle stages small teams need most: document review, approval, training, and periodic review. Route documents through structured review and approval, assign training by revision, collect acknowledgments, verify comprehension, and export audit-ready records. No CAPA, no complaints module, no supplier management — just the document control and training evidence layer done right.
How we think about compliance software
Every design decision in ApprovaDoc starts from the same question: will this help a small team demonstrate compliance to an auditor?
Immutable by design
Acknowledgment records, review decisions, quiz attempts, and audit logs are write-once. No edits, no deletions, no exceptions. What happened stays exactly as it happened.
Built for auditors
Every export, every record, and every workflow is designed around what auditors actually ask for during ISO 13485 and FDA inspections — not around what looks good in a demo.
Right-sized for small teams
Five people or seventy-five. ApprovaDoc is built for teams that need real compliance tooling without six-figure contracts, months of implementation, or dedicated QMS administrators.
Regulatory experience, not just software experience
This product comes from direct experience developing medical devices, navigating FDA and ISO audits, and working inside quality systems that ranged from excellent to barely functional.
Who ApprovaDoc is for
ApprovaDoc is built for small regulated teams — typically 5 to 75 people — working under ISO 13485, FDA QMSR, or similar quality frameworks. That means medical device startups, SaMD companies, digital health teams, and contract manufacturers who need document review, approval, and training evidence without enterprise overhead.
The people who get the most value are QA leads, regulatory affairs managers, and operations teams who are responsible for audit readiness but don't have the budget or bandwidth for a full eQMS implementation. If you have ever spent two days compiling training records from spreadsheets before an audit, this product was built for you.