RegPro gives medical device regulatory affairs teams AI-powered authoring tools — built to the same standard as the submissions they prepare.
Medical device regulatory work has rules that general AI doesn’t respect — jurisdictions, audit trails, traceability, and the kind of citations that hold up under inspection.
A single Class IIa device targeting FDA + EU MDR requires 7–12 documents. Most of that time is spent on structure, formatting, and figuring out which standard applies to which jurisdiction.
General-purpose assistants hallucinate regulatory citations, ignore jurisdiction differences, and generate outputs with no audit trail — making every output a liability, not an asset.
When your senior RA lead leaves, their prompt library, their templates, and their submission patterns go with them — and the next hire starts from scratch.
RegPro keeps your device context, your prompts, and your audit trail in one place — on your machine.
Tell RegPro your device class, intended use, and target jurisdictions. RegPro immediately shows you every document your submission requires.
Choose from an expert-curated prompt library or create your own. RegPro injects your device context and redacts PII automatically.
Run against your chosen AI provider. Review the draft. Accept — and RegPro saves the output with full traceability to the prompt version that produced it.
Every feature exists because a regulatory professional asked for it — not because it looked good in a deck.
Device data, API keys, and audit logs never leave your workstation. DPAPI encrypted at rest. Zero cloud storage of sensitive device information.
DPAPI · AES-256Input device class + target markets. RegPro maps your configuration to the exact submission documents required across FDA, EU MDR, Health Canada, TGA, and more.
FDA · EU MDR · HC · TGAA growing library of expert-authored prompts curated by a former Notified Body assessor — risk management, clinical evaluation, cybersecurity, usability engineering, software lifecycle. Add your own custom prompts to fit your device and workflow.
curated · extensible · versionedEvery action is HMAC-SHA256 hash-chained and tamper-evident. Every output is attributed to the exact prompt version and user that produced it.
HMAC-SHA256 · immutableBring your own API keys for Anthropic Claude, OpenAI, Azure OpenAI, Google Gemini, DeepSeek, xAI Grok, Perplexity, local Ollama, and more. Choose the model for every task. New providers added as the field evolves.
BYO keys · per-task modelUser need → requirement → design → code → test → risk. Maintained as a first-class product feature. Every prompt version is preserved. Nothing is ever deleted.
UR → REQ → DES → TESTRegPro doesn’t lock you into one provider — or charge you a markup on tokens.
More providers added as the field evolves — AWS Bedrock, Google Vertex AI, Mistral, and others on the roadmap.
We don’t just help you prepare IEC 62304 submissions. RegPro itself is developed under IEC 62304 Class A, with full ISO 14971 risk management, IEC 62366-1 usability engineering, and 21 CFR Part 11 electronic records compliance.
“I spent years reviewing medical device submissions as a Notified Body Technical & Clinical Assessor. I saw the same avoidable mistakes slow down life-saving products over and over — not because the teams weren’t capable, but because they lacked tools built for the regulatory context. RegPro is the tool I wished existed.”
RegPro is currently in private beta. We’re onboarding a small number of medical device manufacturers and contract RA firms. Pilot participants get early access, direct input into the product roadmap, and preferred pricing at general availability.
Apply for Pilot AccessOr email us directly at info@teckfile.com