Quality & Regulatory
As a medical device company, our products’ safety and functionality are of the highest importance, as well as delivering a unique customer experience. Human Care ensures success through the adherence to an effective quality management system based on continual improvement, regulatory compliance, and customer satisfaction.
Global Quality Management System
The Human Care´s global quality management system regulates all processes within the Human Care family that handles Human Care´s products, premises, and people. The system is certificated according to ISO13485:2016 and it meets the requirements of 21 CFR Part 820.
For Human Care safety, quality and usability are paramount. We constantly strive to safeguard and enhance the highest quality in all our products. In every detail, in every aspect, our products deliver what they promise.
Human Care should always meet customers’ and authorities’ stringent requirements, needs, and expectations by a customer focus, delivering products and services with high quality. We achieve this through employee professionalism and commitment, ongoing quality training, well-designed quality systems, and continuous, proactive improvement.
Each delivery from Human Care shall be a recommendation for further purchases from us.
Human Care has established regulatory processes that cover the entire regulatory lifecycle management of its products. Compliance with medical device GMP, obtaining regulatory approval and post-market management are the key strengths of Human Care. Our products comply with product standards and certificated when needed.