Three free tools to navigate medical device regulation

Regulatory work is hard to start. Before you write a single quality document, you need to know what class your device is, which regulations apply in your target markets, and what the road to approval actually looks like. We built three free, interactive tools to answer exactly those questions — no account, no sales call, and nothing to install. Here is what each one does.

Device Classification Wizard

Classification is the first fork in the road, and getting it wrong is expensive. The Classification Wizard asks a short series of plain-language questions about your device and shows you where it lands under EU MDR 2017/745 and the FDA framework.

• Step-by-step questions — no regulatory background required
• Your device class under EU MDR and the FDA, side by side
• The likely conformity assessment or clearance pathway for that class
• A clear set of next steps once you know your classification

Startup Launchpad

If you are taking a regulated product from idea to market, the Launchpad maps the whole journey. It breaks the path into milestones — from concept and research through design, risk management, testing, clinical evidence, submission, and launch — with realistic cost and timeline ranges at each stage.

• A milestone-by-milestone roadmap from first idea to market launch
• A short quiz that pinpoints the stage you are at today
• Cost and timeline estimates for every milestone
• The most common mistakes at each stage — and how to avoid them
• A downloadable PDF summary you can share with your team or investors

Regulatory Guide

Once you know your device and your markets, the Regulatory Guide turns that into a concrete compliance picture. Select your product type and the markets you are targeting, and it assembles the regulations, standards, and documentation that apply to you.

• Applicable regulations and standards for your product and target markets
• Estimated submission costs, fees, and time to market
• The regulatory pathway and the documents you will need to produce
• An audit-readiness view and your post-market obligations
• Recommended MoniDoseQMS modules mapped to each requirement
• A full PDF report with source links to the underlying regulations

Why we built them

MoniDoseQMS exists to make quality management simpler for regulated industries. These tools are that same idea offered up front and free: clear answers to the questions every team faces before the compliance work begins. Use them on their own, or as a starting point for building your quality system in MoniDoseQMS.