Regulation feels like a barrier.
We make it a foundation.
Fabola is a specialist regulatory partner for MedTech and IVD companies navigating CE-marking, market entry, and compliance for the first time. We bring the technical rigour of a senior regulatory affairs expert and the strategic clarity of someone who has built companies and understands what is at stake.
The person behind Fabola
I'm Ingela Mauritzon, a MedTech regulatory specialist, academic in innovation science, and founder with an international background spanning the UK, Europe, Singapore, and China.
After more than a decade working across clinical diagnostics, healthcare innovation, and regulatory affairs, including co-founding and running IVD laboratories, I started Fabola to offer something different: regulatory expertise that is grounded in real clinical and commercial experience, not just compliance checklists.
We work primarily with early-stage MedTech and IVD companies, and with non-EU companies entering the European market. Our goal is always the same: to make regulation legible, manageable, and strategically useful and not something to be feared.
How we can help
Regulatory Strategy & CE-Marking
From classification and risk analysis to technical documentation and notified body submission, we guide MedTech and IVD companies through the full MDR and IVDR conformity assessment process. Specialist experience in AI-driven software as a medical device (SaMD), IVD certification, and post-market surveillance.
External PRRC: Person Responsible for Regulatory Compliance
Under Article 15 of MDR/IVDR, every manufacturer needs a PRRC. Micro and small enterprises can engage an external one. We offer dedicated, retainer-based PRRC services that ensure your company meets its legal obligations permanently and continuously, as the regulation requires.
Clinical Validation & Lab Services
Through Fabola Lab Services, we offer independent clinical diagnostics and genomic laboratory services to support regulatory submissions, clinical evaluation, and post-market requirements under MDR and IVDR.
Training & Education
Online and in-person courses and workshops on MDR, IVDR, and global regulatory strategy built for teams, startups, and innovators who need clear, actionable compliance knowledge. Available through the Fabola learning platform and on request.
What makes working with Fabola different
Academic Depth
Apart from our own research in Innovation and Regulatory Affairs, we work at the frontier of how regulation is evolving. We are particularly interested in AI, digital health, and SaMD. Our clients benefit from that perspective.
Clinical and commercial experience
In our team, we have co-founders who have led clinical diagnostics laboratories, validated MedTech performance, and built companies from the ground up. We understand the devices we work with, and we understand the pressures of running an early-stage company.
A guide, not a gatekeeper
Regulation can feel opaque and intimidating, especially the first time around. Our job is to make it clear, navigable, and where possible, strategically useful. We've built regulatory knowledge into our clients' organisations, not just their documents.
Get in Touch
Let's find out if we're a good fit
Whether you are preparing for your first CE-marking, entering the European market, looking to expand globally, or in need of ongoing regulatory support, we would love to hear about your project. Reach out and we can have a conversation about where you are and where you need to get to.
© Fabola AB. All rights reserved.