MediQuasar
Professional consultancy that supports you, improves processes and safeguards the future
With over 10 years’ experience in the field, I support companies and start-ups in managing European regulatory compliance (MDR), developing market access strategies and leveraging safety as a competitive advantage.
Katarzyna Zofia – Regulatory and Quality Affairs Consultant for Medical Devices
Our services
MediQuasar supports companies as a strategic partner, combining technical expertise, regulatory insight and clinical focus to accelerate market access and prevent critical issues. Every project is delivered with a tailored, flexible and independent approach, able to integrate with in-house teams without compromising technical rigour and independent judgement.
The goal is to transform compliance from an obligation into a competitive advantage, creating tangible value: patient safety, risk reduction and sustainable growth for businesses.
AUDIT
Audit services designed to verify the compliance of company processes with applicable regulations, identify risks and non-conformities, and propose corrective actions.
TECHNICAL DOCUMENTATION AND CE MARKING
Services for the preparation and review of the technical documentation required for CE marking and other certifications.
AUTHORISED REPRESENTATIVE
Legal representation services for non‑EU companies to ensure the compliance of products placed on the European market. Includes verification of product compliance and ongoing regulatory support.
MANAGEMENT SYSTEMS
ISO 13485 and ISO 9001 designed to ensure quality, traceability and compliance throughout the device life cycle
CONSULTING
On-site or remote technical‑regulatory and strategic support services to assess project feasibility and ensure process and product compliance.
TRAINING
Training services aimed at transferring knowledge on regulations, quality systems and medical device management, both online and in person.
Person Responsible for Regulatory Compliance: a rare regulatory asset in Europe
MediQuasar provides companies with a high-level regulatory function by taking on the role of Person Responsible for Regulatory Compliance (PRRC) in accordance with the MDR and IVDR.
Dr Katarzyna Zofia Chrusciel is among the few professionals in Europe who meet the requirements set out in the regulations to undertake this high-responsibility appointment, ensuring expertise, independence and continuous compliance throughout the entire device life cycle.
Our work approach
step 1
Introductory call
an informal discussion to understand needs and objectives
step 2
Preliminary assessment and roadmap
development of a tailored plan with clear objectives, timelines and agreed indicators
step 3
Operational consulting and training
an informal discussion to understand needs and objectives. development of a tailored plan with clear objectives, timelines and agreed indicators not just advice, but hands-on support, dialogue with notified bodies, and team development. documented compliance, reduced risks, market expansion, and sustained support over time.
step 4
Results and an ongoing partnership
documented compliance, reduced risks, market expansion, and sustained support over time.
About MediQuasar
MediQuasar is a specialist consultancy for medical devices, IVDs and related products, created to provide technical, regulatory and clinical support—transforming regulatory complexity into clear, actionable pathways. With an independent and tailored approach, we guide organisations of all sizes from concept to market, helping ensure safety, quality and sustainable growth.
Our strength lies in deep specialisation and an integrated perspective across Quality, Regulatory and Clinical Affairs—allowing us to anticipate issues and shorten time to market.
Each engagement is delivered through a flexible, bespoke approach aligned to the client’s needs, whether a start-up bringing its first device to market or a multinational executing remediation programmes.
HAS Consultant for Regulation (EU) 2017/745 and Regulation (EU) 2017/746
Katarzyna Zofia Chrusciel
BIOGRAPHY
Katarzyna Zofia Chrusciel has over 14 years’ experience across Quality Assurance, Regulatory and Clinical Affairs. She advises on both medical devices and in vitro diagnostics, combining strong problem‑solving and team‑building skills with in‑depth expertise in medical‑regulatory writing (BER, CER, PER). Her experience spans pre‑ and post‑market activities (PMS, PMCF, PSUR) and the preparation of vigilance and post‑market surveillance documentation (FSN, FSCA).
She is among the few professionals in Europe qualified to serve as PRRC.
News and insights
Technical deep dives, regulatory updates and practical takeaways to better understand European requirements and stay up to date in a constantly evolving sector.
MDCG guidance: what it is and why it is essential
MDCG (Medical Device Coordination Group) guidance documents are official EU publications that support the practical interpretation of the MDR/IVDR. They are not legally binding, but they represent a key technical reference for manufacturers, notified bodies and other...
MDR 2017/745: a clear overview of the European Medical Devices Regulation
Regulation (EU) 2017/745 (MDR) is the legal framework that governs all medical devices placed on the European market today. Fully applicable since 26 May 2021, it replaced Directive 93/42/EEC (MDD), introducing significantly more stringent requirements in terms of...
Training courses
MediQuasar training courses are designed to provide professionals and companies in the sector with practical skills and up-to-date regulatory insights. Targeted programmes, qualified trainers and a hands-on approach help build immediately applicable knowledge, strengthening in-house teams and making organisations more competitive in a continuously evolving market
Our commitment to ecology and sustainability
Sustainability is an integral part of MediQuasar’s advisory approach. Compliance alone is no longer sufficient: customers, partners and the market increasingly expect environmental accountability and social responsibility.
We guide clients through a practical pathway that also includes:
- reducing waste and improving resource efficiency
- selecting safer, more eco-friendly materials
- meeting environmental obligations (RoHS, REACH, waste)
- engaging teams and leadership on eco-design principles and a greener culture
Get in touch
MediQuasar is here to support you with expert guidance, tailored support, hands-on involvement and a strategic mindset.
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MediQuasar
MediQuasar s.r.l.
Via Vittorio Veneto, 11,
41032 Cavezzo MO, Italia
Phone. +39 393 2859 8580
Mail info@mediquasar.it
Vat no. 04162970364