ai regu työkalut
AI & MDR/IVDR REGULATORY EXPERT DIRECTORY (FIN)
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)
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
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
MDS Finland Oy
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
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)
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