Sabina Nidzworska, PhD

Regulatory Affairs, Quality & IVDR/MDR Consultant – Poland

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Specialization

Sabina Nidzworska is a regulatory affairs and quality-management specialist supporting medical device, in vitro diagnostic and biotechnology companies throughout the product lifecycle. With nearly 10 years of sector experience, she combines scientific expertise with hands-on delivery in EU regulatory strategy, quality systems and clinical/performance evidence.

Based in Poland, Sabina helps innovative companies translate complex EU requirements into practical development, registration and commercialisation plans. At Vim Vitae, she strengthens the team’s ability to support clients with IVDR/MDR readiness, regulatory risk reduction, quality-system implementation and market-entry preparation, particularly for diagnostics and emerging medical technologies.

Key expertise areas

IVDR and MDR regulatory strategy and compliance

ISO 13485 and ISO/IEC 17025 quality-management systems

Technical documentation, regulatory submissions and product registration

Clinical evidence, performance evaluation and risk management for IVDs

Internal audits, CAPA, post-market surveillance and Notified Body readiness

Regulatory support from early product development through market access and lifecycle management

Notable engagements

Science Implementation: Founder and CEO of a consulting company providing regulatory strategy, QMS implementation, SOP optimisation, technical-file review, clinical assessment and business-development support to medical device and biotechnology companies.

Biozek, Imutest and Sensitest: Leads IVDR transition activities across the product portfolios, including ISO 13485 certification support, regulatory documentation, audit and inspection preparation, and coordination with Notified Bodies and regulatory authorities.

GeneMe: Served as Chief Quality Officer, leading the development and continuous improvement of quality systems across R&D, manufacturing and customer-service operations, while directing audit programmes, risk assessments and CAPA activities.

SensDx: Managed ISO 13485 quality systems and regulatory documentation for IVD devices, including self-testing products; supported clinical studies, risk management, technical documentation and EU market-access activities.

Markets

Sabina holds a PhD in Biotechnology, awarded with honours by the Intercollegiate Faculty of Biotechnology of the University of Gdańsk and Medical University of Gdańsk, as well as an MSc in Biotechnology from the University of Gdańsk. Her scientific background includes molecular biology, PCR, next-generation sequencing data analysis and diagnostic-laboratory quality systems.

Her career spans consultancy, R&D project management, regulatory affairs and executive quality leadership. This combination enables her to bridge scientific evidence, quality requirements and regulatory strategy—helping life sciences and diagnostics companies bring robust, compliant products to market efficiently.