Medical Device Quality Management Systems and Regulatory Services

Comprehensive registration services for global markets.

Assess your device's medical classification today.

Navigate EU, FDA, and HC regulations easily.

Expertise in EMC and safety standards compliance.

A medical device is positioned against a plain background. The machine features a screen displaying various icons and controls, likely for diagnostic purposes, and an apparatus for eye examination.

A smartphone displaying an application interface with various diagnostic tools is placed on a surface scattered with dark cylindrical objects resembling large batteries or tools. Beside the phone is a small black device with a label that includes text and a phone number.

Expert Medical Device Consulting Services

Karkinen Consulting Ltd. specializes in medical device regulation, offering comprehensive registration services and expertise including Quality Managment 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