Regulatory Support Built for Small Manufacturers
Under 50 employees, one device or a small portfolio, and an EU market to reach: your constraints are different — and the support should be too.
The constraints
Why Your Problem Is Different
A budget with competition
Your compliance budget competes with development and production. Large-consultancy fees are sized for large clients.
A small team
Regulatory work lands on people who already have a full-time job.
Time to market
Every month before CE marking is a month of costs without revenue.
A steep learning curve
MDR 2017/745 is dense — and reading it is nobody’s day job.
Article 15
The Article 15 Threshold: Written for Companies Like Yours
Article 15 of MDR 2017/745 requires every manufacturer to have a Person Responsible for Regulatory Compliance (PRRC). But micro and small enterprises — fewer than 50 employees and annual turnover or balance sheet total not exceeding €10 million (Recommendation 2003/361/EC) — are not required to employ one: they may appoint an external PRRC, permanently and continuously at their disposal. Medium and large manufacturers must have the role in-house.
It is one of the few places where the regulation explicitly accounts for company size — and it changes the economics of compliance for small manufacturers.
The model
Working with a Single Consultant
Direct access
You talk to the person doing the work — no account manager in between.
Fast decisions
Questions get answers, not tickets.
No internal bureaucracy
No hand-offs between departments, no minimum billable structure.
Continuity
The person who did your gap analysis is the same one supporting your audit.
The process
A Typical Journey
1 · Free initial assessment
30 minutes on your device, your market and your current documentation.
2 · Gap analysis & roadmap
What is missing, what comes first, and realistic milestones.
3 · Implementation support
Documentation, quality management system, risk management, registrations.
4 · Certification & market access
Support through conformity assessment to CE marking.
Typical timeline: 3–9 months, depending on device class, complexity and existing documentation.
Ready to Start?
Free 30-minute initial consultation · Response within 24 hours · No obligation
Regulatory information last reviewed: 10 August 2026