Medical Device Software Consultant / January, 2024 — Present

Cloud solutions | Cybersecurity | Agile Medical Device Development • Transformation of design and development processes into Agile development • Ensuring compliance with IEC 62304, 21 CFR 820, AAMI TIR45 • Cybersecurity processes based on IEC 81001-5-1, NIS-2, AAMI TIR57 • Application of cloud solutions under EU MDR and FDA regulation • QMS digitalization using Confluence, Jira, and SharePoint • Design and pilot implementation of a SharePoint-based application for Computer System Validation (CSV) • Execution of Computer System Validation for internal tools based on IEC/TR 80002-2

Medical Device Software Consultant / January, 2024 — September, 2025

Transformation of design and development processes with a focus on agile development compliant with IEC 62304 ISO 14971 and 21 CFR 820.30. Cybersecurity process implementation based on IEC 81001-5-1. Guidance on cloud applications development and maintenance in the regulated environment. Development of a cloud-based software solution for design control processes (Spring Boot .NET React.js Next.js). Process digitalization using SharePoint and Power Automate technology.

Medical Device Consultant & Project Manager / May, 2022 — Present

🔹 𝗬𝗼𝘂𝗿 𝘀𝘂𝗽𝗽𝗼𝗿𝘁 𝗶𝗻 𝗠𝗲𝗱𝗶𝗰𝗮𝗹 𝗗𝗲𝘃𝗶𝗰𝗲 𝗖𝗼𝗺𝗽𝗹𝗶𝗮𝗻𝗰𝗲, 𝗤𝗠𝗦 𝗗𝗶𝗴𝗶𝘁𝗮𝗹𝗶𝘇𝗮𝘁𝗶𝗼𝗻 & 𝗣𝗿𝗼𝗷𝗲𝗰𝘁 𝗠𝗮𝗻𝗮𝗴𝗲𝗺𝗲𝗻𝘁 🔹 I help MedTech companies navigate regulatory complexity and accelerate medical device development through tailored services: 📗 𝗥𝗲𝗴𝘂𝗹𝗮𝘁𝗼𝗿𝘆 𝗔𝗳𝗳𝗮𝗶𝗿𝘀 & 𝗖𝗼𝗺𝗽𝗹𝗶𝗮𝗻𝗰𝗲 • EU MDR 2017/745, FDA 21 CFR Part 820 & MDSAP consulting • ISO 13485 QMS implementation & certification • Technical documentation for MDR/FDA • EU & US device registration support • Audit readiness (Notified Bodies, FDA, MDSAP) • Internal audits & gap assessments (MDR, ISO 13485, 14971, 62304) • Risk management (ISO 14971), design control (IEC 62304), cybersecurity (IEC 81001-5-1, FDA) • ISMS implementation (ISO 27001, 27701) • CAPA Management 💻 𝗗𝗶𝗴𝗶𝘁𝗮𝗹 𝗤𝗠𝗦 𝗦𝗼𝗹𝘂𝘁𝗶𝗼𝗻𝘀 • QMS digitalization with Jira, Confluence, SharePoint & Power Automate • Custom software tools • Implementation of AI in Quality Management Systems and Regulatory Affairs • Compliance with ISO 42001 - Artificial intelligence — Management system • QMS process automation (training, CAPA, technical documentation) • Validation of the software solutions for regulated environments (ISO 80002) 📈 𝗠𝗲𝗱𝗶𝗰𝗮𝗹 𝗗𝗲𝘃𝗶𝗰𝗲 𝗣𝗿𝗼𝗷𝗲𝗰𝘁 𝗠𝗮𝗻𝗮𝗴𝗲𝗺𝗲𝗻𝘁 • End-to-end project management for medical software development • Cross-functional coordination (RA, QA, R&D, clinical, risk) • MDR/FDA submission management • QMS & certification oversight (ISO 13485, MDSAP, ISO 27001, ISO 42001) • Resource planning, risk mitigation & stakeholder alignment • Project tracking via Jira, Confluence, or SharePoint I have built several ISO 13485 Quality Management Systems from the ground up and successfully brought multiple medical devices to the market. I’d be happy to help you do the same!

Medical Device Software Consultant / January, 2025 — September, 2025

Responsible for end-to-end design of Design Control processes across the complete medical device software lifecycle. • Processes compliant with ISO 13485, IEC 62304, IEC 82304, and 21 CFR 820.30 • Agile methodologies aligned with AAMI TIR45 • Cybersecurity processes in accordance with IEC 81001-5-1 • Cybersecurity integration with risk management and product lifecycle processes • Maintenance, product change, and software architecture processes • SOUP/OTS management process • Interfaces between risk management, usability engineering, and regulatory affairs • Software problem resolution process 💻 Design and pilot implementation of a cloud-based software application for interactive project management and document management

Risk Management Consultant / July, 2022 — November, 2023

• Risk Management on Medical Device Software and Medical Device Systems • Software development of an internal QMS and Risk Management Tools (Spring Boot, React) • Cybersecurity Risk Management • Counselling on Medical Affairs, Regulatory Affairs and Technical Documentation • ISO 14971, IEC 62304, IEC 60601, AAMI TIR57, ISO 11608, MDR (EU) 2017/745

Risk Management Consultant / July, 2022 — November, 2023

Design and development of Project Management and Risk Management software tool (responsible for full stack development - React Typescript Java Kotlin PostgreSQL). Risk management of Medical Device Systems and Combined Medical Products (ISO 14971 IEC 81001 IEC 62304 IEC 60601 ISO 11608). Technical File transition from MDD93/42 to MDR 2017/745. Regulatory Affairs and Medical Affairs counseling on various medical devices.

Quality Management Representative / October, 2020 — April, 2022

• Successful Implementation of QMS and ISO 13485/MDR certification for Medical Device class IIa • Software development - React / React Native / Node.js / Docker • Digital transformation of the Quality Management System • Implementation of Internal Audits, CAPA system, KPIs, Post-Market Activities • Counselling on GDPR, Risk Management, Technical Documentation

Quality Management Representative Software Developer / October, 2020 — April, 2022

Implementation of QMS and ISO 13485/MDR certification for Medical Device Software Class IIa. Software development - React.js React Native Node.js Docker. Digital transformation of the Quality Management System. Implementation of Internal Audits CAPA system KPIs system Post-Market Activities and Management Reviews. Counselling on Medical Affairs GDPR Risk Management and Technical Documentation compliance.

Quality Management Representative / Regulatory Affairs / October, 2019 — October, 2020

• Successful Implementation of QMS and ISO 13485 certification • Implementation of FDA 21 CFR Part 820 and MDR 2017/745 • Design of Risk Management System (ISO 14971) and Technical File (IEC 62304) • Preparation and lead of external audits conducted by Notified Body and pharmaceutical partners

Project Manager - Medical Device Software / May, 2017 — August, 2019

• Development of the software for Technical Documentation and Risk Management - IEC 62304 & ISO 14971 • Leading certification of the Software as a Medical Device (MDR 2017/745) • Clinical Decision Support Tool - Medical Device class IIa (audited by notified body TÜV Süd)

Co-Founder & Lead Project Manager / September, 2009 — August, 2017

• Project management lead of various software projects in logistics, controlling, and e-commerce • Development and maintenance of detailed project plans • Management and coordination of various working groups participating in a project • Managing project deliverables in line with the project plan and stakeholders to ensure the project meets the business needs • Implementation of Agile Project Management (Scrum and Kanban)

Co-Founder & Lead Project Manager / September, 2014 — March, 2017

Responsible for the digital strategy and business development in the CEE region.

Medical Doctor / December, 2011 — March, 2013

Internal medicine physician in emergency and intensive unit care.

Medical Doctor / December, 2011 — March, 2013

Worked in Gastroenterology and Oncology ward, Emergency, Intensive care unit.

Founder Medical Device Lead Consultant / April, 2022 — December

Regulatory consulting for EU MDR 2017/745 FDA 21 CFR Part 820 and MDSAP. Implementation and preparation for certification of ISO 13485 Quality Management Systems. Preparation and review of technical documentation in accordance with MDR and FDA requirements. Support with medical device registration in the EU and US markets. Audit readiness and support during external audits (Notified Bodies FDA MDSAP). Internal audits and regulatory gap assessments (MDR FDA ISO 13485 ISO 14971 IEC 62304). Risk management and documentation compliant with ISO 14971. Design control and documentation according to IEC 62304. Cybersecurity compliance based on IEC 81001-5-1 and FDA. Information Security Management System implementation in line with ISO 27001 and ISO 27701. Digitalization and implementation of eQMS using Jira Confluence Microsoft SharePoint and Power Automate compliant with ISO 13485 IEC 80002 and FDA 21 CFR regulations. Application of AI in Quality Management and Regulatory Affairs in compliance with ISO 42001. Custom software solutions for QMS and regulatory document workflows. Automation of compliance processes including training management CAPA and document control. Validation of software tools and systems used in regulated environments. End-to-end project management for medical device software development. Planning coordination and monitoring of cross-functional teams - software development regulatory affairs quality assurance RD clinical affairs and risk management. Managing regulatory submissions (EU MDR FDA) including timelines document delivery and stakeholder communication. Oversight of QMS compliance internal audits and certification projects (ISO 13485 MDSAP ISO 27001 ISO 42001). Resource and capacity planning task delegation and risk mitigation. Liaison between clients and technical teams ensuring regulatory alignment and project success. Agile project coordination for software development teams (Scrum/Kanban) including sprint planning backlog grooming and daily stand-ups. Experience with tools like Jira Confluence and SharePoint for project tracking and reporting.

Quality Management Representative Risk Manager Regulatory Affairs / September, 2019 — September, 2020

Implementation of QMS and ISO 13485 standards with the final TÜV SÜD certification. Implementation of FDA 21 CFR Part 820 and MDR 2017/745. Design of Risk Management (ISO 14971) and Development Process (IEC 62304). Preparation and lead of external audits conducted by the Notified Body and business partners from the Medical Device Software industry.

Project Manager Medical Device Software Quality Manager / May, 2017 — August, 2019

Design and development of a software for the Design Controls and Risk Management (compliant with IEC 62304 IEC 62366 and ISO 14971). Lead of the Medical Device Software certification (MDR 2017/745). Project management of a Medical Device class IIa Software (audited by notified body TÜV SÜD). Coordination of cross-functioning teams in DACH and APAC regions. Implementation of Quality Management System based on ISO 13485 and Risk Management process based on ISO 14971.

Co-founder of a Software Company / January, 2009 — April, 2017

Project management lead of various software projects in logistics controlling and e-commerce. Development and maintenance of project plans. Management and coordination of the various working groups participating in a project. Managing project deliverables in line with the project plan and stakeholders to ensure the project meets the business needs. Implementation of Agile Project Management (Scrum and Kanban).

Foundation and Management of E-commerce Projects / October, 2008 — January, 2016

Led end-to-end development of multiple online stores across Central European markets. Delivered complete project execution from concept to launch and optimization. Managed cross-functional teams including developers marketers and finance specialists.