01
Expert-led Strategy & Roadmap
Define the optimal CE marking pathway with ex-notified body reviewers who have decades of MDR / IVDR experience. Build a clear, milestone-driven plan from current stage to approval.
The AI-native EU MDR cabinet
Faster, lower-costCE marking.Fixed pricing only.
Gate pairs ex-notified body reviewers and ISO 13485 auditors with our specialized AI platform to accelerate your MDR / IVDR approval across Class I, IIa, IIb, III, MDSW and companion diagnostics. US pathways (510(k), De Novo, PMA) launch Q2 2026.
Adialante — MDR dossierOn track
Technical file
68%
✓GSPR gap analysisDelivered
Technical documentationIn review
Clinical evaluation reportScheduled
Notified body submissionQ4
Who we are
The most experienced MDR cabinet in Europe.
We are a team of ex-notified body reviewers, ISO 13485 lead auditors and AI engineers with decades of combined experience transforming how EU regulatory work gets done.
With milestone-based pricing and faster, higher-quality outputs, our incentives are fully aligned with yours — to deliver medical innovation to European patients significantly faster.
15+
Years spent inside notified bodies
60%
Faster than traditional MDR consultancies
100%
Human oversight by senior reviewers
Want to accelerate your CE marking?
Book a free consultation Our customers
We support the next generation of medical innovation in Europe.
“Gate's ex-notified body experience and regulatory expertise has been invaluable. Their AI-powered approach has enabled us to move faster without compromising quality, all with fixed, risk-free pricing. It was a no-brainer to choose them as our regulatory partner.”
Read the full story
Services
How Gate supports you from strategy to approval.
A unique blend of deep EU MDR expertise and AI engineering — we deliver results, not billable hours.
02
Pre-submissions to CE Mark
Consultants who have reviewed and delivered hundreds of technical files drive the entire process, from GSPR gap analyses through end-to-end authoring, clinical evaluation and final submission.
03
Accelerated with MDR-trained AI
We pair experienced regulatory experts with our custom AI purpose-built for MDR / IVDR workflows to compress timelines, automate manual authoring, and move significantly faster, with constant expert oversight.
04
Fixed, Risk-Free Pricing
No hourly billing. We work on fixed, milestone-based pricing — you only pay when defined deliverables are completed. Aligned incentives, predictable costs, zero risk on execution.
Team spotlight
Our experts are highly experienced and ex-notified body.
Dr. Margaux Renaud, PhD, is a former Principal Reviewer at BSI with 14 years reviewing MDR technical documentation across Class IIa, IIb, and III devices. Margaux holds a PhD in Biomedical Engineering and ISO 13485:2016 Lead Auditor certification. She has reviewed and supported hundreds of technical files — from active implantables to MDSW and companion diagnostics — and has helped startups and public MedTech companies secure CE marking under both MDD and MDR.
Dr. Margaux Renaud, PhD
Principal Regulatory Affairs · ex-BSI Notified Body
Track record
Complex devices, complex classes, delivered to CE mark.
Our team has authored and reviewed filings across all MDR / IVDR pathways and classes — from GSPR strategy through to notified body approval.
Class IIb
Active implantable neurostimulation platform
IVDR Class C
Companion diagnostic for oncology therapy
Class III
Structural heart valve delivery system
MDSW Class IIa
AI-powered radiology triage software
Class IIa
Robotic-assisted surgical planning module
PMCF
Post-market clinical follow-up plan and reports
Why choose us
We are reinventing MDR consulting with state-of-the-art technology.
Bringing medical innovations to European patients faster — without cutting a single regulatory corner.
Other consultants
Other MDR consultancies benefit from slower delivery and unclear timelines — same manual work, more billable hours.
Slower delivery
Unclear costs
Misaligned incentives
Hourly billing
Gate
At Gate we agree on a clear timeline, and work with speed and quality — only paid when we deliver the milestones.
Clear timelines
Fast delivery
Aligned incentives
Risk-free pricing
FAQ
Your questions answered.
Everything you need to know about working with Gate. Still have questions? Book a free call and we'll walk you through it.
Book a free callWe agree on a milestone-based scope upfront — GSPR mapping, technical file authoring, clinical evaluation, submission. You only pay when each milestone is delivered and approved. No hourly overrun, no surprise change orders.