Quality & Documents
Learn about our standards and certifications.
As the first requirement in medical device manufacturing, Hanedan has a certified company management system and the 12,000 sqm production facility which runs with procedures in line with up-to-date regulations. Our products are all manufactured in controlled areas and ISO 8 clean rooms in accordance with the relevant standards complying with MDR (EU) 2017/745, ISO 11140-1 and EN 868-5.
Our Quality Commitment
As Hanedan, we manufacture all our products in controlled areas and ISO 8 clean rooms in compliance with MDR (EU) 2017/745, ISO 11140-1 and EN 868-5 standards, continuously improving our quality assurance systems.
Our Production Standards
12,000 m² Facility
Our large modern production facility operates to the highest quality standards.
ISO 8 Clean Room
All products are manufactured in ISO 8 certified clean room environments.
Raw Material Control
Only certified and market-approved raw materials are used to ensure product safety.
Regulatory Compliance
We operate with procedures fully compliant with MDR, ISO and EN standards.