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 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 safe, 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 – We work systematically with risk management throughout the product lifecycle – from development and manufacturing to use in healthcare – to ensure that the products are safe and beneficial for the user.
- Committed 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 possible way to our quality management work.
Compliance and transparency
Through external audits, we ensure compliance with applicable laws and regulations. We are transparent about the safety, performance, and quality of our products, and we ensure that serious incidents and nonconformities are handled without undue delay and reported to the relevant authorities and users, as applicable. This enables patients, healthcare providers, and partners to have confidence in Kontigo Care’s operations and our products.
Our promise
At Kontigo Care, quality is at the core of everything we do. We are committed to delivering safe, effective, and user-friendly digital tools that support addiction care and create real value for patients and healthcare providers.
Our products are developed and maintained in compliance with applicable regulatory requirements, including ISO 13485 and the EU Medical Device Regulation (MDR).
By continuously monitoring performance and using a structured approach to improvement, we ensure that our technology remains reliable, secure, and fit for its intended purpose—today and over time.
