Medical Device Regulatory & Quality Expertise
My professional background spans medical device and IVD regulation, quality management, risk management and technical standards.
Regulation & Standards
Device qualification, classification, EU MDR and IVDR, market requirements, EMC, electrical safety and medical device software standards.
Quality & Risk Management
ISO 13485 quality systems, ISO 14971 risk management, technical documentation and regulatory change assessment.
Professional expertise and enquiries
My experience covers device qualification and classification, regulatory pathways in the EU, US and Canada, quality management systems, risk management, EMC, electrical safety and medical device software lifecycle requirements.
This expertise informs my work at Innokas Medical and the articles published on this website.
You are welcome to contact me directly to discuss your needs. QA/RA consulting engagements are arranged through Innokas Medical. Scilife eQMS and other enquiries are handled by Karkinen Consulting Oy.
Regulatory & Quality Insights
Articles and professional perspectives by Jouni Karkinen.
QA/RA consulting engagements are arranged through Innokas Medical. Scilife eQMS and other enquiries are handled by Karkinen Consulting Oy.
contact information
Karkinen Consulting Oy, Helsinki, Finland
Business ID: 3103786-9
info@karkinen.com
NATO NCAGE code A10CG
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