About us

Experience, rigour and a proven method—serving safety and sustainable growth.

Compliance, quality and vision to move every project confidently towards market access. 

About MediQuasar

MediQuasar is a specialist consultancy in Regulatory Affairs, Quality and Clinical Affairs for medical devices, IVDs and related products. It was founded to help companies and professionals turn European regulatory complexity into clear, sustainable and results‑driven pathways.
With an independent, rigorous and hands‑on approach, we support organisations of all sizes, ensuring safety, compliance and growth.

Mission, vision e values

We work with a clear purpose: enabling the development of safe, compliant and high‑quality devices. Our mission, vision and values underpin every engagement—driving consistency, integrity and responsible decision‑making.

Why choose MediQuasar

Technical depth, a tailored approach and hands‑on delivery—this is what makes MediQuasar different. We act as a strategic partner, transforming compliance into a real competitive edge

Our approach

The MediQuasar method combines structured analysis with practical support at every step. A four‑stage journey designed to deliver transparency, effectiveness and measurable results across the full product life cycle.

The founder

Dr Katarzyna Zofia Chrusciel brings over 14 years’ experience across Regulatory, Clinical and Quality. She provides expert leadership and is among the few professionals in Europe able to assume the PRRC role under the MDR/IVDR.

Person Responsible for Regulatory Compliance (PRRC)

The PRRC role is a critical responsibility under the MDR/IVDR, entrusted only to professionals with proven technical and regulatory competence. MediQuasar provides this service as a qualified external function, ensuring oversight, rigour and continuous compliance.

Discover why the PRRC role is a strategic asset for your business >>