# Mangold MedTech – Niko Mangold, Regulatory Strategist

> Website: https://mangold-medtech.com
> Contact: niko@mangold-consultants.com
> LinkedIn: https://www.linkedin.com/in/niko-mangold/
> Booking: https://calendly.com/niko-mangold-consultants/15min

## About

Niko Mangold is a Regulatory Strategist specializing in EU MDR and IVDR for medical devices. He helps researchers, physicians, and MedTech founders navigate regulatory requirements to get to market faster. With 40+ international regulatory projects, he turns regulation into a strategic advantage.

## Services

- **Regulatory Quick Test** (Free, 5 min): Find out where you stand and get your three most important next steps.
- **Classification – AI Check & Workshop** (from €97, BAFA-eligible): AI-powered MDR/IVDR classification check or full-day personal workshop with roadmap.
- **Clear to Launch Sessions** (€20/month): Monthly live sessions on regulatory topics. 30 min input + 30 min Q&A. Limited to 15 participants.
- **Long-term Partnership** (from €3,000/month): Personal Regulatory Strategist — from classification to audit.

## Target Audience

- Researchers & Founders — from prototype to approval
- Physicians & Clinicians — bringing medical innovation to market
- MedTech Startups — convincing investors with a clear regulatory roadmap

## Credentials

- 40+ international regulatory projects
- Author – MedTech Regulatory Guide
- ai4mdr – proprietary AI tools for regulatory tasks
- Lecturer at 4C Accelerator & Health Captains Club Member

## Detailed Information

For comprehensive information, see: https://mangold-medtech.com/llms-full.txt

## Sitemap

https://mangold-medtech.com/sitemap.xml