About ReguPartner – Supporting MedTech Innovators with Expert Regulatory Guidance
Our Vision and beliefs is that a Quality Management system should be the backbone of a company and not a burden to carry.
Our mission is to empower our costumers to reach their MDR approval journey safely and cost effective, dedicating their time and energy to build products safely and with highest Quality
With over 15 years of combined experience in quality assurance and regulatory affairs, I’ve successfully led the development and certification of medical device software under the MDR.
This includes building compliant Quality Management Systems, preparing technical documentation, and managing submissions to Notified Bodies.
That hands-on experience is now the foundation of ReguPartner — providing expert support to MedTech companies working to meet today’s complex regulatory demands with clarity and confidence.
Our Core Values
- Professionalism & Quality
- Innovation & Adaptability
- Customer Focus & Trust
- Integrity & Responsibility
Discover how our expert services can support your MedTech innovation journey.
About the Founder
Certified ISO 13485 Internal Auditor and regulatory expert with 15 years in software and MedTech, dedicated to helping companies balance compliance and innovation. I help startups, scale-ups, and established companies navigate complex regulatory challenges and bring innovative products safely to market.
Before founding ReguPartner, I served as Chief Quality & Regulatory Officer and PRRC at FRISQ AB, and later as Quality & Regulatory Affairs Manager at Cambio Group. I successfully led MDR transitions, built ISO 13485-compliant Quality Management Systems from the ground up, and guided CE-marking processes for digital health software across Europe.
My expertise spans ISO 13485, ISO 14971, ISO 27001, FDA regulations, GDPR, HIPAA, IEC 62304, and emerging AI regulations (ISO 42001). At ReguPartner, I leverage this hands-on experience and a pragmatic approach to help MedTech companies stay compliant, agile, and innovation-focused.
Why I Started ReguPartner
After years working in-house, I witnessed how many companies struggle to balance compliance with agility. ReguPartner was created to make regulatory support simpler, faster, and more effective—tailored to the realities of modern MedTech development.
Founder & CEO
