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AI & MDR/IVDR REGULATORY EXPERT LIST
AI & MDR/IVDR REGULATORY EXPERT LIST (FIN)
This page provides a directory of experts in AI and MDR/IVDR regulation who offer advisory and professional services related to the regulation of medical devices and artificial intelligence in Finland.
The list is intended to support companies and organizations in identifying and procuring external regulatory expertise. It is provided for informational purposes only and should not be considered an endorsement or recommendation of any individual expert or service provider. The information has been compiled to facilitate access to contact details and services within the regulatory field.
All information is based on submissions provided by the service providers themselves. The AI Regu project does not assess the quality of the services offered and is not responsible for their delivery or outcomes. The list is maintained by the AI Regu project and updated based on information received from listed organizations and experts. Contact us via the link below to requests for additions or updates.
The list is publicly available and may be freely shared.
Haapanen Anna
Dittmar & Indrenius Attorneys Ltd.
LL.D., Partner, Head of Technology, Licensing & Data
anna.haapanen@dittmar.fi
Puh: +358 400 992 925
LinkedIn
Sector
Legal Services
Regulatory Areas
AI Act
Data Act
MDR
GDPR
Intellectual Property
EHDS
Services
– Data and technology law
– Development and commercialization of AI solutions and other technology products and services
– Medical device regulation
– Health technology regulatory environment
– Complex contractual matters and negotiations
– Regulatory authority proceedings and dispute resolution
– Intellectual property matters and licensing
– Financing arrangements and mergers & acquisitions (M&A)
Keywords
Artificial Intelligence (AI) Solutions
Health Technology (HealthTech)
Medical Devices
Cloud Services
Intellectual Property Rights (IPR)
Contracts and Commercial Agreements
Dispute Resolution
Financing Arrangements and Mergers & Acquisitions (M&A)
Harjuveteläinen Katri
Regulyn Oy
CEO and Senior Consultant
katri.harjuvetelainen@regulyn.com
Puh: +358 4578 7478 10
LinkedIn
LikedIN Regulyn
Sector
Legal and Regulatory Consulting
Regulatory Areas
AI Act
MDR
IVDR
Clinical Trials Regulation (CTR)
Secondary Use of Health and Social Data and EHDS
NIS2
Data Governance and Data Regulation
Services
– Advisory services on AI regulation
– Support in developing AI governance frameworks and policies
– Advisory services on research legislation (including clinical research, secondary use of data, and regulatory requirements for the use of AI in research)
– Drafting and negotiating research-related agreements (including research agreements, consortium agreements, and data transfer agreements)
– Aligning AI, data protection, and sector-specific regulatory requirements
– Tailored consulting on complex issues related to health technology, data, and research
Keywords
Compliance Support
AI Regulation
Research Legislation
Regulatory Alignment in Complex Environments
Research Agreements
Health Technology
Data Utilization
Clinical Research
Holappa Terhi
UNA Oy
Development Manager
terhi.holappa@unaoy.fi
Puh: +358 44 468 5010
LinkedIn
Sector
Expert and Advisory Services
Regulatory Areas
MDR
AI Act
Services
– Training and support for wellbeing services counties on the regulation of medical device software (MDSW), including MDR and AI Act requirements.
– Delivering training for various stakeholder groups through events organized in collaboration with training and educational partners.
– Participating in expert mentoring and advisory activities through the SOTE AI Ecosystem MDR_AI Support Clinic.
– Contributing to the national implementation and adoption of MDR and AI Act requirements in collaboration with networks, projects, public authorities, industry associations, and the SOTE AI Ecosystem, particularly the Wellbeing Services Counties AI Network
Keywords
MDR
Medical Device Software (MDSW)
AI Act
Medical Device Artificial Intelligence (MDAI)
Practical Implementation of Regulatory Requirements
Key Industry Standards
Health Technology Usability (including IEC 62366-1 and IEC TR 62366-2)
Advisory Services
Training
Korhonen Kirsi
Korsi Key Oy
CEO, Consultant
kirsi.korhonen@korsikey.fi
Puh: +358 44 546 6066
LinkedIn
Sector
Business Consulting and Regulatory Consulting for Software Development
Regulatory Areas
MDR
AI Act
Services
– Consulting and advisory services, particularly on MDR and AI Act requirements
– Classification of software as a medical device (SaMD)
-Regulatory pathways and regulatory strategy development for health technologies
– Project management for software development and regulatory projects
– Quality management systems (QMS) and process development
– Preparation, review, and improvement of technical and product documentation
– Requirements management
– Training courses and workshops
Keywords
MDR
AI Act
Software as a Medical Device (SaMD)
Quality Management Systems (QMS)
Processes
Technical Documentation
Project Leadership
Regulatory Strategy
Consulting
Advisory Services
Person Responsible for Regulatory Compliance (PRRC)
Training
Workshops
Internal Auditing
ISO 13485
ISO 14971
IEC 62304
IEC 62366-1
IEC 82304-1
IEC 81001-5-1
Koskinen Katja
Nometech Oy
CEO
katja.koskinen@nometech.fi
LinkedIn
Sector
Consulting
Regulatory Areas
MDR
FDA
Services
Expert regulatory support for medical device companies, with a particular focus on health technology startups and scale-ups, covering regulatory strategy, market access, and quality management systems. Services include interpretation of EU MDR and FDA requirements, regulatory pathway planning, and the development and implementation of quality management systems aligned with market expectations, such as ISO 13485, MDSAP, and FDA QMSR.
Nometech supports organizations in integrating regulatory strategy into product development from the earliest stages. Activities include regulatory advisory and coaching, training, preparation of technical documentation, and readiness support for certification processes, notified body interactions, and regulatory submissions.
Keywords
MDR
FDA
SaMD (Software as a Medical Device)
QMS (Quality Management System)
QMSR (Quality Management System Regulation)
Technical Documentation
Project Management
Regulatory Strategy
Consulting
Advisory Services
PRRC (Person Responsible for Regulatory Compliance)
Training
Workshop
Quality Manager as a Service
ISO 13485
ISO 14971
IEC 62304
IEC 62366-1
IEC 60601 Series
Liede Sandra
Laissa Oy
Legal Expert
sandra.liede@laissa.fi
Puh: +358 40 700 1658
LinkedIn
Sector
Legal Services and Legal Advisory, with a focus on Health Technology and Life Sciences
Regulatory Areas
MDR
IVDR
AI Act
GDPR
EHDS
Secondary Use of Health and Social Data Act (Toisiolaki)
Services
– Legal advisory and consulting for health technology and life sciences organizations
– Interpretation and practical application of regulatory requirements in business operations
– Risk and liability assessment
– Regulatory strategy support
– Simplification of complex legal and regulatory matters
Keywords
MDR
IVDR
AI Act
GDPR
EHDS
Secondary Use of Health and Social Data Act (Toisiolaki)
Legal Advisory
Regulatory Interpretation
Business-Oriented Regulatory Compliance
Risk and Liability Assessment
Regulatory Strategy
Compliance Support
Health Technology Law
Life Sciences Regulation
Legal Consulting
Maijala Miikka
Clinius Oy
CEO
miikka.maijala@clinius.fi
Phone: +358 40 509 6160
LinkedIn
Sector
Regulatory Affairs (RA), Quality Assurance (QA) and Clinical Research
Regulatory Areas
MDR (Medical Device Regulation)
IVDR (In Vitro Diagnostic Medical Devices Regulation) ISO 13485
Services
– Planning, management and reporting of clinical device investigations
–Support for clinical evaluations
– Quality management and CE marking documentation services
– ISO 13485 quality management system services
– Regulatory and risk management consulting from a clinical implementation perspective
– Artificial intelligence as part of a medical device
Keywords
Clinical device investigations
Clinical evaluation
ISO 13485
Quality management systems
Documentation support
Risk management
Regulatory compliance services
Nevalainen Suvi
DigiFinland Oy
Chief Legal Officer, Data Protection Officer
suvi.nevalainen@digifinland.fi
suvi.nevalainen@gmail.com
Puh: +358 50 516 4202
LinkedIn
Sector
Consulting
Regulatory Areas
MDR
AI Act
Digital Health Regulation
Data Protection and Information Security (EU Regulatory Framework)
Services
– Training and advisory services for DigiFinland’s owner-customers
– Training services as an independent side activity
– Legal advisory on AI, MDR, data protection, and digital health services
Keywords
MDR
AI Act
Digital Solutions Regulation
Nurminen Lassi
Managing Director
lassi@mdsfinland.com
Puh: +358 50 535 1237
LinkedIn
Sector
Consulting
Regulatory Areas
MDR
IVDR
ISO 13485
FDA
AI Act
CRA (cyber resilience act)
Services
– Quality management systems aligned with ISO 13485 requirements
– Quality and compliance consulting
– PRRC (Person Responsible for Regulatory Compliance)
– Technical Documentation (EU CE Marking)
– Clinical Evaluations (CEP / CER)
– Biological Evaluations (BEP / BER)
– Support for FDA approval processes (510(k), De Novo, PMA)
– Training and testing services (e.g., ISO 10993 and IEC 60601)
– Artificial Intelligence as Part of a Medical Device
– Clinical Investigations
– IPR Strategy
Keywords
Compliance Support
CE Marking Support
Technical Documentation
Quality Management Systems
Clinical Investigations
O’Rourke Stephen
Clarifi Oy
Founder | Regulatory Strategy & Commercialisation
Stephen@Clarifi.fi
LinkedIn
Sector
Regulatory Strategy and Commercialisation Advisory for Early-Stage Medical Device, Digital Health and AI-Enabled HealthTech Companies.
Regulatory Areas
EU MDR
EU IVDR
S FDA medical device pathways (including 510(k))
EU AI Act considerations for AI-enabled medical devices
Services
– Early regulatory guidance for startups: Helping founders understand whether their technology is likely to qualify as a medical device, what classification may apply, and what this means for their development plans.
– Regulatory strategy before significant investment: Identifying potential regulatory barriers, costly assumptions and evidence requirements before companies commit substantial time and resources to development or testing.
– EU and US market-entry planning: Helping startups understand their potential regulatory pathways under the MDR, IVDR and FDA frameworks, and how these may influence product development and commercialisation.
– Medical device software and AI-enabled technologies: Assessing regulatory implications of intended purpose, software functionality, AI integration, third-party technologies and product claims.
– Evidence and development planning: Helping teams understand what clinical, technical and risk-management evidence they may need, what they can establish now, and what can reasonably wait until later.
– Regulatory decision briefs and independent assessments: Focused reviews that give founders, research teams and investors a clearer understanding of regulatory options, uncertainties, risks and recommended next steps.
– Startup mentoring and practical workshops: Working directly with founders and development teams to help them understand regulatory requirements, ask better questions and make informed decisions as their technologies evolve.
Keywords
Early-Stage HealthTech Startups
MedTech Startups
Regulatory Strategy
Regulatory Feasibility
Medical Device Qualification and Classification
Intended Purpose
MDR
IVDR
Medical Device Software (MDSW)
Software as a Medical Device (SaMD)
AI-Enabled Medical Devices
AI Act
FDA 510(k)
EU/US Market Entry
Evidence Planning
Clinical Evaluation
ISO 14971
IEC 62304
Regulatory Due Diligence
Research Commercialisation
Startup Mentoring
Regulatory Decision Support
Rahnasto Johanna
Roschier Asianajotoimisto Oy
Senior Associate, Attorney-at-Law
johanna.rahnasto@roschier.com
Puh: +358 20 506 6727
LinkedIn
Sector
Legal Services and Legal Advisory
Regulatory Areas
AI Act
Data Act
MDR ja IVDR
IPR
GDPR
EHDS and the Secondary Use of Health and Social Data Act (Toisiolaki)
ePrivacy
ICT Law and Regulation
Services
– Regulatory advisory for the health technology sector, including medical devices, data, and artificial intelligence
– Application of legislation, risk management, and compliance support in technology, data protection, and ICT-related matters
– Intellectual property services, including patents, trademarks, and copyright
– Contractual matters, including licensing, research, development and collaboration agreements, software and cloud service agreements, and sales and distribution agreements
– Legal advisory in marketing, consumer protection, and product liability matters
– Assistance in regulatory and administrative proceedings
– Dispute Resolution
Keywords
Artificial Intelligence and Health Technology Law
Intellectual Property Rights (IPR)
Data Protection
Contracts
Dispute Resolution
Compliance Advisory
Licensing
Mergers and Acquisitions (M&A)
Riihimäki Tiina
Foundtri Oy
Founder, Principal Advisor
info@foundtri.com
LinkedIn
LinkedIn Foundtri
Sector
Strategic regulatory and quality consultancy combined with international business support for health technology, medical devices (MD), in vitro diagnostics (IVD), and medical device-pharmaceutical interface matters. Expertise serves startups, scale-ups, medical device and IVD manufacturers, pharmaceutical companies, as well as importers and distributors of medical devices and diagnostic solutions.
Regulatory Areas
EU Medical Device Regulation (MDR)
EU In Vitro Diagnostic Medical Devices Regulation (IVDR)
UK Medical Devices Regulations (UK MDR)
Swiss Medical Devices Ordinance (MedDO)
FDA Regulatory Compliance
Good Vigilance Practices (GVP)
Medical Device Requirements for Drug-Device Combination Products and Regulatory Framework Interfaces
Services
– Strategic Advisory: Aligning regulatory and quality requirements with business objectives, product portfolio strategies, and international growth plans.
– International Market Access and Trade Support: Assessing regulatory requirements and evidence expectations in target markets, planning registration pathways, and clarifying the responsibilities of distribution partners and supply chain stakeholders.
– Support for Startups and Growth Companies: Defining regulatory pathways at an early stage, establishing phased approaches to documentation and quality management system development, and prioritizing resources for the activities most critical to the next development or market-entry phase.
– Strategic Expert and Leadership Roles: Providing senior regulatory and quality expertise, leading international regulatory and quality projects, and assembling the required specialist competencies through the Foundtri Expert Network.
– Regulatory and Quality Support Across the Product Lifecycle: Supporting product development and lifecycle management through technical documentation, risk management, conformity assessment preparation, and post-market activities. Includes clinical evaluations and performance evaluations.
– Quality Management Systems: Developing and improving quality management systems, preparing organizations for audits, supporting corrective actions, and providing guidance in notified body selection, application processes, and conformity assessments.
– Drug-Device Combination Products: Supporting device documentation requirements, Notified Body Opinion (NBOp) applications, and related assessment processes for drug-device combination products.
– Capability Management: Assessing current and future competence needs, defining responsibilities, and planning training, mentoring, and external expert support in alignment with organizational objectives.
Keywords
Strategic Regulatory and Quality Advisory
International Trade and Market Access
Startups, Scale-ups, and International Expansion
Target Markets and Supply Chain Economic Operator Responsibilities
MDR, IVDR, and Combination Products
Medical Device Software (MDSW)
Technical Documentation, Quality Management Systems (ISO 13485), and Product Lifecycle Management
Usability Engineering (IEC 62366)
Biological Safety and Biocompatibility (ISO 10993)
Product and Process Risk Management (ISO 14971)
Capability Management
Project Leadership, Capability Continuity, and Professional Networking
Rotonen Mikko
Triconsult Oy
Consulting Services Director
mikko.rotonen@triconsult.fi
Puh: +358 40 737 3707
LinkedIn
Sector
Consulting
Regulatory Areas
AI Act
MDR
Services
– Medical Device Software (MDSW) Development in Compliance with ISO 13485
– ISO 42001 AI Management and Optimization
Keywords
Product Development Support
MDSW (Medical Device Software)
ISO 13485
ISO 42001
Tyni Tiina
Tmi Tiina Tyni
Medical Device MDR Regulatory Expert
info@tiinatyni.com
LinkedIn
Sector
Consulting
Regulatory Areas
Medical Device Regulation (MDR)
AI Act
Services
– Medical Device Regulation (MDR)
– CE Marking Process
– Regulatory Strategy
– Technical Documentation Preparation
– ISO 14971 Risk Management
– Clinical Evaluation
– Post-Market Surveillance (PMS)
– Serious Incident Handling and Reporting
– Instructions for Use (IFU) and Product Labeling
– UDI and EUDAMED Registrations
– Liaison with Notified Bodies and Competent Authorities
– Support for Distributors and Importers
– ISO 13485 Quality Management System Development
– Due Diligence Assessments
– Other EU Legislation Relevant to Health Technology (e.g., AI Act, Battery Regulation)
– Regulatory Expert Review of AI-Generated Content
Keywords
Understanding MDR Requirements
Practical Implementation of MDR Requirements
MDR CE Marking Certification Process
AI Act Support
Wakkinen Janica
PromedQarax Oy
Partner & Sr. Consultant, Business Development Manager
janica.wakkinen@promedqarax.com
Puh: +358 40 722 1981
LinkedIn
Sector
Consultation; healthtech, medical devices and in vitro diagnostics
Regulatory Areas
MDR
IVDR
FDA
UK MDR
Swiss MedDO, IvDO
AI Act
Data Act
Services
– Quality Assurance: ISO 13485 quality systems, audits, validation, and interim quality leadership.
– Regulatory Affairs: Strategy, submissions, and technical documentation across the EU, UK, Switzerland, the US, and other territories.
– Clinical Affairs: Clinical evidence, planned and maintained across the lifecycle.
– Post-Market Surveillance: PMS planning, literature and safety database searches, PMSR/PSUR and PMPF/PMCF reporting.
– eQMS & PLM: Evaluate, select and implement the right quality and lifecycle management systems.
– Training: Custom training, ready-made packages and mentoring.
– Project Management, including regulatory and quality projects
– See more: https://promedqarax.com/services/
Keywords
Quality & Regulatory (QARA) consultation
Regulatory advice
Quality Assurance
QMS / eQMS
Supplier Quality Management
Auditing
Technical Documentation
MDSW / AIaMD / SaMD / SiMD
Cyber security
Due Diligence / Gap Analysis
PRRC
Training
Project Management
ISO 13485
ISO 14971
ISO/TS 24971-2
IEC 62304
IEC 81001-5-1