Quality and Regulatory

Expert guidance for medical device registration and compliance worldwide.

A blue protective face mask with a white print displaying certification details, including CE marking and standards compliance. The mask features ear loops and a structured design.
A blue protective face mask with a white print displaying certification details, including CE marking and standards compliance. The mask features ear loops and a structured design.
EMC Consulting

Ensuring compliance with electromagnetic compatibility standards effectively.

A wooden table displays various hearing aid devices in their respective cases. Several head-shaped models showcase the devices. In the background, a screen is visible with abstract green and blue graphics.
A wooden table displays various hearing aid devices in their respective cases. Several head-shaped models showcase the devices. In the background, a screen is visible with abstract green and blue graphics.
Risk Management

Implementing ISO 14971 for effective risk assessment and management.

Karkinen Consulting provides exceptional guidance on medical device regulations and quality management systems. Expertise in EU and country requirements is invaluable for your product registration process.

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

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