Medical Device Quality Management Systems and Regulatory Services

Assess your device's medical classification today.

Navigate EU, FDA, and HC regulations easily.

Expertise in EMC and safety standards compliance.

More information? Please, use the contact form at the end of the page.

Expert Medical Device Consulting Services

Karkinen Consulting specializes in medical device regulation, offering comprehensive registration services and expertise including Quality Management Systems in compliance across EU and other markets.

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
Y-identification: 3103786-9
info@karkinen.com