MedTech Regulatory Strategy Consulting made simple
We turn regulatory chaos into clarity for startups and scale-ups
Market Access, Regulatory strategy, ISO 13485 QMS, and global MedTech compliance — for startups, scale-ups, and industry leaders.
About Us:
Your Strategic Partner in MedTech Compliance
Niko Mangold
Founder & Regulatory Strategist
- Lecturer in MedTech Regulatory Affairs
- Expert in MDR compliance consulting, FDA regulatory consulting, ISO 13485, SaMD & AI regulatory support
- Guiding innovators from prototype to approval
Why Choose Our ISO 13485 and MDR Strategy Consulting?
| ✅ | Startup-Speed QMS – Launch-ready ISO 13485 systems in 6 weeks |
| 🌍 | Global Strategy – MDR, FDA, SFDA, Health Canada, UK, MEA, etc. |
| 🤖 | AI & Software Compliance – SaMD, machine learning, eIFUs, more |
| 🧩 | Trusted Network – Connected to top notified bodies, certifiers, and MedTech partners across Europe |
Need clarity on your next move?
Our MedTech Regulatory Strategy Consulting Services
QMS in 6 Weeks
Fast-track ISO 13485 implementation tailored for startups:
Together with 123Certify
EU MDR & FDA Strategy
Our MedTech regulatory strategy consulting services support startups through every phase — from strategy to CE/FDA approval.
AI & SaMD Compliance
Future-proof your software with expert support
International Market Access
Get registered in EMEA, US, Canada, GCC, and beyond
Workshops & Training
Custom team training on compliance and innovation:
Together with RT-University
What Our Clients Say
We’ve worked with several consultants, but Niko’s strategic input, industry connections, and deep MDR expertise made the difference. It felt less like outsourcing and more like having an internal expert on speed dial.
— RA Lead, Digital Health Company, Switzerland
Working with Mangold Consultants helped us go from zero to audit-ready in just a few weeks. Niko understood the pressure we were under and gave us both a clear regulatory roadmap and the confidence to move forward.
— Founder, AI Diagnostics Startup, Germany
Backed by Experts. Connected to Results.
Regulatory Thinking
We are proud to be an RT Approved Vendor, officially recognized by Regulatory Thinking – a leading initiative that bridges the gap between regulatory compliance and strategic innovation in the MedTech industry.
Regulatory Thinking brings together top-tier consultants, educators, and industry partners to support startups, scale-ups, and established companies on their journey toward regulatory excellence. Rooted in a collaborative network that includes universities, notified bodies, and global experts, Regulatory Thinking empowers health tech innovators to align compliance with business success.
As an approved vendor, we meet the high standards of quality, expertise, and reliability that Regulatory Thinking demands. Whether it’s in the field of regulatory strategy, technical documentation, or market access – our solutions are vetted, trusted, and ready to support your path to certification and sustainable growth.
Our Trusted MedTech Compliance Partners
Swiss Lifescience Consultants
Expertise in Swiss and EU market access, ISO 13485 consultants, and regulatory affairs consultants
surgeSupply
Specialists in clinical, quality, and PMS documentation for complex devices
ai4mdr
The AI-powered assistant for regulatory intelligence and documentation
123Certify
Fast-track ISO 13485 implementation — your QMS, certified in 6 weeks
QSInternational
Trusted Notified Body & Certification Partner for ISO 13485 and MDSAP
Let’s Bring Your Innovation to Market — Compliantly
Whether you’re launching your first device or scaling internationally, we’ll help you meet regulatory requirements without losing momentum. As specialists in MedTech regulatory strategy consulting, we guide innovators through ISO 13485, MDR, and FDA processes. Let’s turn compliance into your competitive advantage.