IPP · People
Meet the Team
Engineering precision meets regulatory pragmatism. Our team enables MedTech founders to move from prototype to market-ready device with clarity, speed, and audit confidence — centered on the Easy13485 Makerspace.
Dr. Volker Klügl
Founder & Managing Director
Dr. Volker Klügl accelerates medical device market entry and minimizes lifecycle costs through smart management of resources, requirements, and regulations. With 30+ years in engineering and leadership, he bridges strategic and operational project management for complex MedTech systems.
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Accelerating Medical Device Market Entry. Dr. Volker Klügl is your partner for MDR and Regulatory Affairs in MedTech. He focuses on reducing lifecycle costs by aligning resources, requirements, and regulations early and pragmatically.
Volker is a mechanical engineer (Dipl.-Ing.) with over 30 years of experience. Before founding IPP in 2005, he served in senior leadership roles. His long-standing work as a consultant — with emphasis on project management — spans both strategic-conceptual and hands-on delivery in complex technical programs.
He completed his PhD in Cardiff, Wales, and entered industry in 1992. In 2001, he moved into consulting; since 2002, his focus has been complex MedTech projects. Over the years, he has grown with the regulatory demands of Class IIb devices. Since 2015, he has concentrated on change programs driven by the digital product file, MDSAP, and MDR.
Expertise: Regulatory Affairs, MDR-compliant technical documentation, regulatory project leadership, large-scale programs, process consulting for MDR, and clinical evaluations — from IPP’s base in Nuremberg, Bavaria.
IPP Managers
The leadership core of IPP — combining strategic insight, technical depth, and regulatory precision to shape the vision and ensure excellence across all client engagements.
Felix Nickel
Manager · Medical Device Expert & Project Management
Felix Nickel specializes in validation of medical devices and compliant production processes. With a Master’s in Medical Engineering (TH Regensburg) and TÜV certification as a Process Validation Expert, he blends deep technical know-how with practical project delivery — aligning R&D, risk and regulatory to speed releases and ensure MDR-conform documentation.
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Profile
Felix Nickel is a specialist in medical device validation and the implementation of robust, compliant manufacturing processes. He completed his M.Sc. in Medical Engineering at the Technical University of Regensburg, focusing on medical R&D and acquiring broad capabilities across electrical engineering, medical informatics, materials science and medical device law.
Experience Highlights
- Process Validation: Supported one of the world’s largest dental manufacturers with validation of a manufacturing process for a camera-based intraoral 3D scanner.
- TÜV-certified: Process Validation Expert (Medical Devices); designs validation/qualification strategies and documentation when processes cannot be fully verified.
- Evidence Structures: Builds validation plans and the associated documentation structures required for regulatory compliance.
Current Role
Design Control Project Lead at Sirona Dental Systems GmbH, driving development of capture technologies for high-precision digital dental impressions and authoring MDR-conform technical documentation.
Expertise
- Process Software Validation & Qualification
- MDR-compliant Technical Documentation
- Regulatory Project Management & Large Programs
- Lean, scalable Quality Systems
Felix operates from Nuremberg (Bavaria) and supports clients in accelerating market entry while minimizing lifecycle costs by aligning resources, requirements and regulations early.
Moritz Nickel
Manager · Medical Device Expert & Project Management
Moritz Nickel is a verification specialist for medical devices with a strong background in medical engineering and production technology. He focuses on designing and executing robust verification plans, aligning design inputs/outputs, risk, and documentation to meet MDR requirements efficiently and predictably.
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Verification of Medical Devices. Moritz Nickel is an experienced specialist in verification for medical devices, combining hands-on project execution with deep knowledge of production technologies, device engineering, and prosthetics.
Over the years, Moritz has built practical verification frameworks that connect design control, risk management, and evidence creation to MDR expectations. He supports both the refinement of existing technical documentation and the end-to-end creation of MDR-conform files for new products.
Experience Highlights
- Planning and execution of verification activities (V&V), from test strategy and protocols to data analysis and reporting.
- Bridging R&D and production to ensure testability, manufacturability, and compliant records.
- Strengthening DHF/TF structures so submissions become predictable rather than last-minute sprints.
Expertise
- Verification (V&V) & Test Method Development
- MDR-compliant Technical Documentation
- Design Control & Risk Management (ISO 14971)
- Production Technology & Process Readiness
- Project Management & Cross-functional Delivery
Moritz helps teams reduce cycle time and rework by aligning evidence early with realistic product risks and regulatory criteria—keeping projects on schedule and audits predictable.
Alexander Nellner
Consultant · Medical Device Expert & Regulatory Support
Alexander Nellner supports MedTech development and market introduction with a focus on technical documentation and MDR conformity. He bridges engineering detail and regulatory structure — ensuring risk, verification, and clinical strategy flow into submission-ready documentation.
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Alexander Nellner is a Medical Device Expert with a strong technical foundation and practical experience in documentation, verification, and regulatory compliance. His work ensures that product evidence, process control, and quality systems remain aligned throughout the full product lifecycle — from concept through CE submission.
Experience Highlights
- Development and maintenance of MDR-compliant technical documentation (DHF / TF).
- Support in verification planning, execution, and data reporting to ensure traceability to design inputs.
- Integration of risk management and usability evidence according to ISO 14971 / 62366.
- Collaboration with notified bodies and cross-functional R&D teams to streamline reviews.
Expertise
- Technical Documentation & DHF / TF Architecture
- Verification & Validation (V&V) Strategies
- MDR & ISO 13485 Implementation
- Risk & Usability Engineering (ISO 14971 / 62366)
- Regulatory Project Management
Alexander helps MedTech innovators reduce regulatory friction by integrating compliance tasks directly into development workflows — keeping documentation lean, structured, and ready for audit or submission at any time.
IPP Consultants
The leadership core of IPP — combining strategic insight, technical depth, and regulatory precision to shape the vision and ensure excellence across all client engagements.
Bettina Nachmann
Senior Consultant · Regulatory Affairs & Quality Management
Bettina Nachmann combines regulatory expertise with practical experience in quality and process management for medical devices. Her focus lies in supporting manufacturers to meet MDR and ISO 13485 requirements while maintaining efficient, scalable business operations.
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Regulatory Affairs & Quality Systems Leadership. Bettina Nachmann supports MedTech companies in building and maintaining compliant quality management systems, implementing MDR requirements, and aligning organizational processes with regulatory expectations.
With many years of experience in regulatory and operational functions, she helps companies transition from reactive compliance to proactive quality culture — enabling predictable audits, structured technical documentation, and long-term scalability.
Experience Highlights
- Setup and optimization of ISO 13485-compliant QMS for SMEs and startups.
- Gap assessments and implementation of MDR-conform technical documentation.
- Process analysis and improvement for design control, risk, and post-market surveillance.
- Training and coaching of cross-functional teams for regulatory readiness.
Expertise
- Regulatory Affairs (MDR / IVDR)
- ISO 13485 Quality Management Systems
- Process Development & Continuous Improvement
- Technical Documentation & Risk Management
- Internal Audits & Supplier Qualification
Bettina empowers MedTech organizations to operate confidently within regulatory frameworks — turning compliance into a driver of trust, quality, and business growth.
Nadine Pauli
Consultant · Regulatory Affairs & Quality Management
Nadine Pauli supports MedTech teams with MDR- and ISO 13485-aligned execution — from process setup and documentation flows to day-to-day regulatory operations. Her focus is practical compliance: clear structures, clean evidence, and predictable audits.
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Regulatory enablement for growing teams. Nadine helps startups and SMEs operationalize MDR requirements and ISO 13485 processes without overloading teams. She builds lean documentation pathways that create audit-ready evidence as work happens.
Core Work
- Authoring and maintaining MDR-conform technical documentation (DHF/TF).
- Supporting QMS build-out and harmonization with development reality.
- Risk management integration (ISO 14971) across design control and verification.
- Post-Market Surveillance (PMS) and PMCF planning, execution, and reporting.
How She Works
Partnering closely with engineering and product leads, Nadine aligns regulatory deliverables with meaningful milestones — enabling faster submissions and smoother NB interactions.
André Cakici
Consultant · Quality Management & Regulatory Affairs
André Cakici supports medical device manufacturers in developing and maintaining MDR- and ISO 13485-compliant processes. His focus is translating complex quality requirements into clear, applicable systems that work in everyday product development.
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Building efficient compliance frameworks. André Cakici combines technical precision with regulatory insight to create scalable, compliant processes for medical device manufacturers. He focuses on lean documentation, efficient QMS structures, and clear interfaces between R&D and QA.
Experience Highlights
- Setup and maintenance of ISO 13485-compliant quality systems.
- Risk management and CAPA process alignment across multi-site environments.
- Supplier qualification and auditing to MDR / ISO 13485 requirements.
- Coordination between regulatory and engineering functions for CE submissions.
Expertise
- Quality Management Systems (ISO 13485)
- MDR Compliance & Documentation
- Risk Management (ISO 14971)
- Audit Preparation & Supplier Management
- Continuous Process Improvement
André’s approach emphasizes practicality and efficiency — ensuring compliance becomes an enabler, not an obstacle, for MedTech innovation and production excellence.
Corinna Locke
Consultant · Regulatory Strategy & Technical Documentation
Corinna Locke crafts MDR- and ISO 13485-compliant documentation with a reviewer-friendly structure. She translates regulatory requirements into clear templates, consistent records, and submission-ready files that reduce rework and keep audits predictable.
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Regulatory clarity without the bloat. Corinna focuses on building documentation architectures that match product reality — aligning GSPRs, risk, verification evidence, and post-market activities into one coherent story for reviewers.
Experience Highlights
- Authoring and harmonizing MDR Technical Documentation (DHF/TF) for SaMD and device manufacturers.
- Gap assessments against MDR & ISO 13485 with practical remediation plans and templates.
- Preparation for NB interactions: structure, traceability, and evidence mapping.
Expertise
- MDR Technical Documentation & Submission Prep
- Quality Management Systems (ISO 13485)
- Risk Management (ISO 14971) & GSPR Mapping
- Verification Evidence & Traceability
Her approach emphasizes readability, traceability, and consistency — so teams stay fast while meeting regulator expectations with confidence.
Georgina Niedermayer
Consultant · Regulatory Affairs & Technical Documentation
Georgina Niedermayer supports MedTech companies in preparing MDR-compliant documentation and implementing efficient regulatory workflows. Her focus lies in bridging product development with regulatory requirements to create technical files that withstand audits and accelerate approvals.
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Connecting regulatory precision with development agility. Georgina Niedermayer assists teams in translating design and clinical insights into structured, audit-ready technical documentation. Her expertise ensures that compliance supports, rather than slows, the innovation process.
Experience Highlights
- Preparation of MDR-compliant technical documentation and device classification support.
- Hands-on experience in documentation architecture, risk analysis, and usability engineering.
- Support in CAPA documentation and post-market surveillance setup for SME environments.
Expertise
- Regulatory Affairs (MDR, ISO 13485)
- Technical Documentation & Device Files
- Risk Management (ISO 14971)
- Usability & Clinical Evaluation Support
Georgina’s structured approach helps streamline regulatory deliverables so teams can stay focused on development and market success.
Jonas Jung
Head of Academy · Startup Enablement & Digital Learning
Jonas Jung drives the Easy13485 Academy — translating complex MDR and ISO 13485 concepts into actionable learning experiences. His focus is empowering startup teams to apply regulatory structure from day one through interactive eLearning and ready-to-use templates.
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Bringing clarity to MedTech learning. Jonas combines regulatory expertise with a passion for learning design. At IPP, he creates digital enablement programs that help startup teams internalize MDR principles without the need for lengthy workshops or consulting hours.
Experience Highlights
- Design and management of the Easy13485 Academy — IPP’s digital learning platform for MedTech startups.
- Development of guided learning paths for QMS setup, risk management, and technical documentation.
- Close collaboration with consultants and auditors to ensure educational content meets real audit standards.
Expertise
- Regulatory eLearning & Digital Onboarding
- MDR / ISO 13485 Enablement
- Learning Experience Design (LXD)
- Process & Quality Training for MedTech Teams
Jonas helps MedTech innovators reduce compliance overhead through education — building regulatory knowledge directly into product development routines.
Maren Fiedler
Consultant · Regulatory Affairs & Quality Systems
Maren Fiedler supports medical device companies in establishing and maintaining regulatory compliance under MDR and ISO 13485. She focuses on pragmatic, scalable QMS processes that strengthen product safety and documentation efficiency throughout the lifecycle.
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Efficient compliance through structure and clarity. Maren Fiedler advises MedTech teams on regulatory alignment and QMS implementation tailored to their organization’s maturity. Her approach bridges strategic compliance goals with day-to-day practicality, ensuring teams can focus on innovation while meeting audit expectations.
Experience Highlights
- Implementation and maintenance of ISO 13485 systems for SME and startup environments.
- Preparation and coordination of MDR Technical Documentation for Class IIa/IIb devices.
- Internal audits, supplier management, and CAPA facilitation.
Expertise
- Regulatory Affairs (MDR / IVDR)
- Quality Management (ISO 13485)
- Audit Preparation & QMS Optimization
- Risk Management (ISO 14971)
Maren combines analytical precision with practical regulatory insight, enabling clients to turn compliance into a driver of process excellence and trust.
Emil Klügl
Team Operations & Media
Emil supports IPP’s day-to-day operations and media production. He helps keep processes organized, coordinates materials across projects, and contributes to visual content that explains complex regulatory topics with clarity.
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Emil works across operations and media to keep projects moving smoothly and communication crisp. He supports the team with content preparation, light design tasks, and the organization of assets for Academy modules, client materials, and the Makerspace.
Focus Areas
- Operational coordination and task follow-up
- Media prep for Academy & Makerspace content
- Document organization and publishing support
- Cross-team assistance for events and client deliverables
What he adds
A reliable backbone for the team: hands-on support, quick turnaround, and a clear eye for presentation. Emil helps translate complex topics into clean, digestible formats that fit the IPP style.
Gabriela Röding
Regulatory Consultant · Quality Systems & Clinical Evaluation
Gabriela Röding supports manufacturers in establishing and maintaining compliant quality management systems and MDR technical documentation. She combines regulatory expertise with strong organizational skills, helping teams to create clear, audit-ready deliverables and align clinical evaluation strategies with overall business goals.
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Profile. Gabriela Röding contributes her expertise in regulatory affairs, quality assurance, and documentation processes for medical device manufacturers. Her approach is structured, reliable, and detail-oriented — ensuring every document and process step meets MDR and ISO requirements.
Core Competencies
- Implementation and maintenance of ISO 13485-compliant QMS
- Preparation and structuring of MDR technical documentation
- Support for clinical evaluation reports and post-market surveillance
- Process documentation and continuous improvement initiatives
Working Approach
Gabriela’s work is characterized by a precise and efficient approach to regulatory deliverables. She bridges the gap between technical documentation, quality system requirements, and practical implementation — enabling teams to maintain compliance without overcomplication.
Darja Blisse
Quality & Regulatory Consultant · Technical Documentation & MDR Compliance
Darja Blisse supports medical device manufacturers in the preparation and maintenance of technical documentation, risk management files, and quality management systems. Her structured and detail-oriented approach ensures MDR-compliant, audit-ready documentation and smooth project execution.
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Profile. Darja Blisse contributes her regulatory expertise to the preparation of medical device documentation and quality system processes. Her experience covers MDR technical files, risk management per ISO 14971, and internal audit support.
Core Competencies
- Development and maintenance of MDR-compliant technical documentation
- Integration of regulatory requirements into QMS workflows
- Risk management and usability documentation (ISO 14971 / IEC 62366)
- Audit preparation and CAPA coordination
Approach
Darja’s approach is analytical and quality-driven — translating complex regulatory requirements into actionable documentation frameworks that meet both notified body and customer expectations.
IPP Certified Partners
The leadership core of IPP — combining strategic insight, technical depth, and regulatory precision to shape the vision and ensure excellence across all client engagements.
Marco Schön
Quality Management & Process Validation
Marco supports MedTech startups and manufacturers in building and maintaining efficient, audit-ready quality management systems. With hands-on experience in validation and MDR-compliant process design, he ensures product realization is smooth, traceable, and compliant from day one.
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Marco specializes in the setup and optimization of quality management systems (QMS) for medical device manufacturers. His focus lies on creating lean, effective documentation structures and ensuring consistent regulatory compliance throughout development and production.
Core Competencies
- Implementation of ISO 13485-compliant QMS structures
- Validation of manufacturing and testing processes
- Preparation and execution of supplier and internal audits
- Support for MDR and FDA submission readiness
Experience
Marco has supported both startups and established manufacturers through multiple QMS implementations, helping teams establish control plans, risk assessments, and technical documentation structures that satisfy notified body expectations while keeping workflows efficient.
His approach emphasizes practicality and efficiency — ensuring compliance never slows down innovation.
Martin Schröder
Senior Regulatory Consultant · Risk Management & Technical Documentation
Martin supports MedTech teams in structuring MDR-compliant documentation and risk management that hold up in audits. He combines hands-on engineering insight with clear regulatory execution — aligning design control, V&V, and post-market planning to keep submissions predictable and timelines on track.
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Profile. Martin Schröder brings structured, reviewer-friendly execution to regulatory workstreams. He plans and authors MDR technical documentation, builds risk files aligned to real-world use, and ensures design verification is traceable to product requirements and GSPRs.
Core competencies
- Risk management per ISO 14971 (hazards, HARs, risk controls, residual risk)
- DHF/TF authoring and gap closure against MDR & NB expectations
- Design Control & V&V planning, traceability, and test evidence
- Post-Market (PMS/PMCF) strategy and practical implementation
- ISO 13485 process integration and audit preparation
Working style
Pragmatic, evidence-first, and fast. Martin favors clear templates, short decision cycles, and early alignment with notified-body reviewers to de-risk timelines and avoid costly rework.
Udo Roth
Finance & Operations · Business Administration & Strategic Development
Udo Roth oversees finance, administration, and internal operations at IPP. With extensive experience in strategic business planning, process optimization, and financial control, he ensures the company’s sustainable growth and operational excellence.
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Profile. Udo Roth brings decades of managerial and financial expertise to IPP. His focus lies on efficient resource planning, transparent performance structures, and sustainable company growth.
Core Competencies
- Financial planning and controlling
- Operational and organizational development
- Process optimization and efficiency improvement
- Business strategy and implementation
- Cross-departmental coordination and governance
Approach
Udo Roth ensures that financial precision and organizational structure go hand in hand with innovation. His method combines pragmatic decision-making with data-driven planning to create long-term stability and scalability.
IPP Backoffice
The leadership core of IPP — combining strategic insight, technical depth, and regulatory precision to shape the vision and ensure excellence across all client engagements.
Christina Klügl
Operations & Business Administration
Christina ensures smooth day-to-day operations at IPP — coordinating finance, contracts, and vendor processes, and keeping teams supplied with the structure and information they need to move fast. She connects administrative precision with a service mindset so projects and audits stay predictable.
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Christina supports IPP’s operational backbone with a focus on finance, purchasing, and contract administration. She streamlines recurring workflows, maintains clean records for audits and due diligence, and ensures project teams have the right resources at the right time.
How she helps teams
- Operational clarity: standardized templates and checklists for smooth onboarding, purchasing, and document handling.
- Reliable coordination: vendor and service management, scheduling, and communication across stakeholders.
- Evidence readiness: tidy records and version control to keep internal audits and external reviews stress-free.
Focus areas
- Financial & administrative processes
- Contract & supplier coordination
- Document stewardship for audits & due diligence
- Office & resource management
Ursula Roth
Business Administration · Accounting & Finance
Ursula Roth manages accounting and financial administration at IPP, ensuring transparent, compliant financial processes and smooth coordination with partners and auditors. With years of experience in bookkeeping and controlling, she supports the management team in maintaining stability and efficiency.
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Reliable financial backbone for innovative teams. Ursula oversees IPP’s accounting and controlling processes, ensuring every project runs on a solid administrative and financial foundation. Her structured, analytical approach keeps operations compliant and transparent across internal and external stakeholders.
Core Focus
- Financial accounting and invoice management
- Budget control and liquidity planning
- Preparation of documentation for audits and due diligence
- Coordination with tax advisors and external partners
Experience
Ursula combines years of experience in financial administration with a pragmatic understanding of the MedTech industry’s operational requirements. Her goal is to enable the IPP team to focus on innovation and regulatory excellence, backed by clear, reliable financial structures.