Commitment to Quality
At ALMS Medical Srl, we are committed to providing our customers with safe, effective, high-quality medical products. Our commitment to quality begins with our associates. All ALMS Medical Srl associates play a part in the quality of our products as outlined in our ALMS Medical Srl Quality Policy.
ALMS Medical Srl Quality Policy
All ALMS Medical Srl associates are committed to maintaining the overall effectiveness of our Quality Management System. Working as a team, ALMS Medical Srl 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 ALMS Medical Srl’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 ALMS Medical Srl 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.
ALMS Medical Srl distributes products to over 60 countries and complies with international medical device regulations, including Europe.