Karkinen Consulting Oy Medical Device Regulatory and QMS Consulting
Device classification and regulatory pathway
EU MDR, FDA and Health Canada registration support
QMS, EMC and safety standard compliance
Practical regulatory and quality support for medical device companies entering EU, US and Canadian markets.
Regulatory and QMS support for medical device teams
Karkinen Consulting supports medical device companies with practical regulatory, quality and compliance expertise. Services cover device classification, registration planning, ISO 13485 quality management systems, risk management, EMC and electrical safety compliance, and implementation support for modern eQMS tools.
15+
Trusted by Professionals
Years of Experience
Expert Regulatory Services
Providing comprehensive consulting in medical devices regulation across multiple global markets with expertise.
Medical Device Consulting
Assess if your device qualifies and meets medical device regulations in your specific market area.
EMC Consulting
Contact Us
Reach out for expert guidance on medical device regulations and registration services across various regions.
Quality and Regulatory Consulting
Expert services in medical device regulation and quality compliance.
contact information
Karkinen Consulting Oy, Helsinki, Finland
Business ID: 3103786-9
info@karkinen.com
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