Our Quality Work
Kontigo Care operates according to the high standards applicable to medical devices and complies with both MDR and ISO 13485.
Quality is more than a Routine – It’s the Foundation of our Entire Operation
At Kontigo Care, quality is more than a routine – it’s the foundation of our entire operation. Our Quality Management System (QMS) meets the requirements of ISO 13485, EU Regulation 2017/745 for medical devices (MDR) and essential parts of ISO 27001. The quality management system covers design and development, manufacturing, distribution, and service of medical device software and associated hardware.
How We Work with Quality
- Safe products and services – Our products and services are developed to be secure, effective, and in line with current regulations. We have CE-marked medical devices for the treatment of addiction disorders, and we work systematically to maintain the highest safety and performance.
- Continuous improvement – Through internal audits, effective management of deviations, and ongoing monitoring of how the products function in practice, we continuously improve our products and procedures to meet users’ needs and expectations.
- Risk management at all stages – We work systematically with risk management throughout the product’s lifecycle – from development and manufacturing to use in healthcare – to ensure that the products are safe and beneficial for the user.
- Engaged employees – With clear goals, we promote our employees’ engagement and motivation. By investing in skills development, we build knowledge so that each employee can contribute in the best way to our quality work.
Compliance and Transparency
Through external audits, we ensure good compliance with applicable laws and regulations. We are transparent about our products’ safety, performance, and quality, where serious incidents and deficiencies are handled promptly and reported to relevant authorities and users. This way, patients, healthcare providers, and partners can feel confident in Kontigo Care’s operations and our products.
Our Promise
We are committed to delivering safe, effective, and user-friendly digital tools for addiction care, and we see quality as a driving force for innovation, patient benefit, and long-term success.
At Kontigo Care, quality is the foundation of everything we do. Our products comply with regulatory standards (ISO 13485 and MDR) and are developed with a focus on safety, efficiency, and user-friendliness. Through continuous monitoring and improvement, we ensure that our technology creates real benefits for patients, healthcare providers, and society.
