Quality Management with Kasve
Get to know our work with quality management and regulatory affairs.
Environment for medical software development to Migrevention
Migrevention is a digital headache clinic solution for patients, specialists, and clinics to manage migraine and other primary headaches. Kasve implemented a project with Migrevention in which an environment was created for the development of medical software.
With the help of Kasve, we developed a marketable medical device in a year
Together with Kasve, Nursie Health built a quality management system for their mobile application, which is a medical device.
Growth requires a quality management system
Nordic Laboratories did a preliminary study with Kasve for the clinical laboratory's quality management system, and is now building the quality management system itself.
We launched the product as planned
Together with Kasve, Adamant Health built a quality management system on time to enable them to apply for the CE mark for their medical device.
Kasve brought us enourmous Quality Management know-how
Together with Kasve, Kustannus Oy Duodecim has built a Quality Management System in accordance with the ISO 13485 standard, and is developing software product in accordance with the IEC 62304 standard.
Credibility for a Start-up with a QMS Certificate
Kasve supported Buddy Healthcare in building up the EN ISO 13485 compliant Quality Management System and developed company's internal auditing further.
Etsimo: ISO 13485:2016 Quality Management System
Team Kasve built up together with Etsimo key personnel an ISO 13485:2016 QMS that, for example, enhances the company’s R&D activities, risk management and training of personnel.
Cerenion: ISO 13485:2016 Quality Management System
Kasve helped to build up ISO 13485:2016 QMS that, for example, enhances company’s R&D activities, risk management and training of personnel. Kasve also participated into software development documentation.
Blueprint Genetics: ISO 15189 – Quality Management System for clinical research laboratory
Team Kasve was responsible for building up a QMS to match ISO 15189 and US CLIA, Clinical Laboratory Improvement Amendments, requirements, and worked as an outsourced quality manager.