MedTech Startups: Secure your road to CE marking.
Launching a medical device isn't a technical sprint — it's a regulatory marathon. The MAC AI assistant guides you from ideation to post-market surveillance. Secure your time-to-market and reassure your investors from day one, without blowing up your burn rate.
Your regulatory journey, step by step.
From the very first idea to post-market surveillance, MAC has you covered.
Ideation & R&D
Ideation & R&D
Your reality
Technology moves fast. You don't yet have a QMS, and the wall of standards (ISO 13485, ISO 14971) feels overwhelming in front of a blank page. You push the paperwork to later.
What MAC brings
Stop building in the dark. Your assistant guides you in writing your first procedures (SOPs). From day one it connects your Design Inputs to your Design Outputs.
Structuring & Pivots
Structuring & Pivots
Your reality
Your product pivots, making your documentation obsolete. Worse, your VC investors demand guarantees during regulatory due diligence.
What MAC brings
Absolute agility. MAC checks the impact of your design changes on your documentation. When facing investors, present an objective MAC compliance score (A to F), proving that your project is "Due Diligence Ready".
The Notified Body wall
The Notified Body wall
Your reality
The moment of truth. The stress is intense: one missing item, one traceability gap — and your file is rejected.
What MAC brings
The AI acts as an uncompromising pre-auditor. MAC scans your Technical File, ensures "Submission Readiness", and generates preventive CAPA action plans.
Post-CE marking
Post-CE marking
Your reality
You celebrate your certification. Then comes lifecycle management (Change Control), Post-Market Surveillance (PMS), and evolving standards.
What MAC brings
Effortless maintenance. MAC continuously evaluates your QMS. A new standard appears? MAC runs an instant Gap Analysis.
Preserve your runway, maximize your valuation.
The cost of a certification delay is measured in lost months of runway. Hiring full-time consulting firms from day one is financially unsustainable. A MAC subscription lets you internalize premium expertise for a fraction of the cost.
The Technical File module is what interests us most. Your tool could address our needs without having to bring in very expensive consultants.
Built by founders, for founders.
Backed by the top names in French innovation, we founded, certified, and sold our own medtech startup. Read our story →
100% Plug & Play — compatible with your tools
Don't let regulation break your momentum.
Bring the rigor of a premium auditor in-house today, and focus on what really matters: innovation and your patients.