-- MEDICAL DEVICE REGULATORY & QUALITY CONSULTING
From a question to a workable plan.
Complex requirements. Clear next steps.
01 Understand the product
02 Identify what matters
03 Make progress
Regulatory support
Quality & risk management
Standards & compliance
-- PRACTICE AREAS
The expertise you need. A scope that makes sense.
Classification & market access
Quality systems & risk management
EMC, safety & software
Understand your device's regulatory status and plan the work needed for your target markets.
Build and improve practical processes for quality management, risk management and controlled documentation.
Connect relevant standards to your product, development activities and supporting evidence.
-- SENIOR ADVISORY
Jouni Karkinen
Direct access to experienced support.
Medical Device Regulatory & Quality Consultant
I am Jouni Karkinen, founder of Karkinen Consulting. I help medical device companies turn regulatory and quality requirements into practical work.
Helsinki, Finland
20+ years of professional experience
-- COMPANY BRIEF
-- REGULATORY INSIGHTS
Industry updates and practical guidance.
Articles addressing MDR classification challenges, quality management documentation updates, and international compliance strategies.
Scilife eQMS implementation support
Structured onboarding, process digitization, and validation for medical device teams.
Tell me about your device, target market and the support you need.
