-- MEDICAL DEVICE REGULATORY & QUALITY INSIGHTS
From requirements to understanding.
Complex requirements. Clear next steps.
01 Understand the product
02 Identify what matters
03 Follow what changes
Regulatory insights
Quality & risk management
Standards & compliance
-- AREAS OF EXPERTISE
Medical device quality and regulatory expertise.
Classification & market access
Quality systems & risk management
EMC, safety & software
Medical device and IVD qualification, classification and regulatory requirements in the EU, US and Canada.
ISO 13485 quality systems, ISO 14971 risk management and documentation supporting product safety and compliance.
Standards and regulatory considerations for electromagnetic compatibility, electrical safety and medical device software.
-- ABOUT JOUNI
Jouni Karkinen
Experience, insights and practical perspectives.
Medical Device Regulatory & Quality Consultant
I am Jouni Karkinen, founder of Karkinen Consulting Oy. I work in quality and regulatory affairs at Innokas Medical and share professional insights through this website.
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.
Contact me directly about articles, QA/RA, Scilife eQMS or other questions. QA/RA consulting engagements are arranged through Innokas Medical. Scilife eQMS and other enquiries are handled by Karkinen Consulting Oy.
