Axiom Biotek is a Stockholm-based regulatory and quality consultancy for the medtech and pharma industries — medical devices, diagnostics and drug-device combination products across the EU, UK and US. We also act as EU Authorised Representative for manufacturers outside the Union, under a documented quality system with a qualified PRRC.
At larger agencies, the person who pitches you is rarely the person who does the work. Here they're the same people — one who has run the regulatory and quality side, one who has built and financed a medtech company from scratch.
Alice Mattsson
Commercial & Product StrategyAlice is a medtech founder and CEO who has built a company from first principles. She founded and leads Pharmista Technologies (ova&me), a Stockholm diagnostics venture developing a reusable pregnancy test — taking it from an observation on a pharmacy shelf to granted patents in Sweden, Europe and PCT, a completed proof of concept, and a funded prototype programme.
Her experience spans executive management, product development, business development, fundraising and commercial strategy — including Horizon Europe's Women TechEU programme, Sweden's SmiLe Incubator, and funding through the BioInnovation Institute (BII), the Copenhagen-based venture institute backed by the Novo Nordisk Foundation — alongside assembling the scientific and technical team to deliver the product.
At Axiom Biotek she brings the founder's-eye view: what regulatory and quality work really costs a young company in time, money and momentum — and how to sequence it so it earns its keep commercially.
Callum Kitson-Parker
Regulatory & QualityCallum is a regulatory and quality consultant working across medical devices, diagnostics and drug-device combination products in the EU, UK and US — from strategy and gap assessment through technical documentation, submissions and QMS.
He has also sat inside startups as a core team member, not just an outside adviser — coordinating engineers, scientists and management through the full journey from early development to market.
He leads Axiom Biotek's Authorised Representative service and serves as the point of contact for competent authorities and notified bodies. His view is that compliance should accelerate a product to market, not stand in its way — which means building only what regulators require and the team can actually maintain.
A close network, brought in when it's needed
Some engagements need more than regulatory and commercial expertise. We work with a close, vetted network of specialists — cybersecurity, software development, and marketing and business development — brought in only when a project calls for them.