Dr Chrusciel began her career in HSE, quality and environmental fields, gaining first-hand experience of multidisciplinary collaboration and the impact of clear, measurable processes. In 2011, she shifted her focus to medical devices—seeing compliance not as a constraint, but as a catalyst for innovation and patient safety.

 She has held senior operational and management roles—including Corporate Director for Quality Management & Regulatory Affairs (Europe), Principal Consultant (Global) and MDR Project Leader (Europe)—leading regulatory teams, shaping market access strategies and delivering remediation programmes across Europe and internationally.

 Since 2021, she has supported MDR/IVDR implementation as an HAS consultant. As an outsourced PRRC and consultant, she works alongside organisations to build ISO 13485 quality systems, strengthen technical documentation, manage clinical and performance evaluation, and ensure robust post-market surveillance and vigilance.

With a strong interest in continuous learning and sustainability, she champions projects where compliance enables growth: leaner processes, clearer metrics, transparent engagement with notified bodies and internal capability building—helping organisations become more autonomous, resilient and faster to execute

Areas of expertise

• Regulatory: MDR/IVDR, EUDAMED, FDA 510(k); classification, UDI, labelling, MDD/IVDD → MDR/IVDR remediation
• Clinical/Performance: CER/PER (ISO 14155, MEDDEV 2.7.1 Rev. 4, MDR Article 61, MDCG 2020-5/6); plans/reports, gap analysis, literature review
• Post-market: PMS, PMCF, PSUR; surveillance protocols, trending, KPIs and continuous improvement
• Vigilance: FSN, FSCA, incident management and competent authority communications
• Quality: ISO 13485, ISO 9001, internal/supplier audits, data integrity, CAPA, change control
• Risk & Usability: ISO 14971, IEC 62366; biocompatibility (ISO 10993)
• Special processes and validations: EO sterilisation (ISO 11135); packaging/transport (ISO 11607, ISTA 2A, ASTM D4169)

Values, work ethic and commitment

Dr Chrusciel’s work is grounded in transparency, accountability and capability transfer. Over time she has developed a tailored consulting model that integrates seamlessly with in-house teams as a trusted, flexible external function—while maintaining technical rigour and independent judgement.

Her focus goes beyond meeting regulatory requirements: it is about delivering measurable business value through pathways that combine safety, quality and sustainable growth.
This commitment supports long-term partnerships built on ongoing dialogue, continuous updates and mutual trust.