Commitment to Quality
At Ferrosan Medical Devices Sp. z o.o., we are committed to providing our customers with safe, effective, high-quality medical products. Our commitment to quality begins with our associates. All Ferrosan Medical Devices Sp. z o.o. associates play a part in the quality of our products as outlined in our Ferrosan Medical Devices Sp. z o.o. Quality Policy.
Ferrosan Medical Devices Sp. z o.o. Quality Policy
All Ferrosan Medical Devices Sp. z o.o. associates are committed to maintaining the overall effectiveness of our Quality Management System. Working as a team, Ferrosan Medical Devices Sp. z o.o. associates are empowered and committed to meeting and exceeding their internal and external customers' expectations while complying with all Quality Management System processes which assure we meet the requirements of ISO 13485, FDA Quality System Regulations, and all other applicable regulations.
Quality Certifications
Each and every associate plays an integral part in the success of Ferrosan Medical Devices Sp. z o.o.’s quality management system. This focus has resulted in earning certification to the internationally recognized standard for medical device quality management systems, ISO 13485:2016. The certification shows that Ferrosan Medical Devices Sp. z o.o. has demonstrated the ability to provide medical devices that consistently meet customer and applicable regulatory requirements.
Regulatory Compliance
The safety and effectiveness of our medical device products are kept in compliance with FDA 21 CFR 820, EU Medical Device Regulation (EU MDR), EU In Vitro Diagnostic Medical Device Regulation (EU IVDR), Canadian Medical Device Regulations (CMDR), as well as all other applicable medical device regulations.
Ferrosan Medical Devices Sp. z o.o. distributes products to over 60 countries and complies with international medical device regulations, including Europe.