Axiom Biotek is a regulatory and quality consultancy for medtech and pharma — EU MDR/IVDR, FDA and UK MHRA, from strategy and submissions through QMS and EU representation. Senior-level, hands-on, no hand-offs.
Classification, pathway and submission-ready documentation for EU MDR/IVDR, FDA 510(k)/PMA and UK MHRA — including notified body and agency interactions.
02Pragmatic ISO 13485 and FDA QMSR systems — right-sized for startups, remediated for scale-ups, audit-ready for everyone.
03Fluent in both rulebooks: essential drug delivery outputs, Article 117, human factors and design controls that satisfy drug and device reviewers alike.
04Legal representation under MDR/IVDR Article 11 for manufacturers outside the Union — with real regulatory oversight, not a letterbox.
Axiom Biotek is Alice Mattsson and Callum Kitson-Parker — a medtech founder and CEO, and a regulatory and quality consultant. Product development, fundraising and commercial strategy on one side; submissions, QMS and EU representation on the other.
You work directly with the people doing the work — from first gap assessment to submission day and beyond.
More about Axiom BiotekA short note is enough — we'll come back within one business day with an honest view of whether and how we can help.