Korsi Key Oy

Korsi Key Oy can help bring your health technology ideas to life without regulatory pains and problems! We offer the following services and more: ⚖️ Regulatory strategy planning and medical/non-medical device justifications for software 🛡️ Quality management systems for Software as a Medical Device ⚙️ Design and development processes 📋 Requirement specifications 🧭 Project leadership for health and wellbeing technology projects 🌱 Workshops, facilitation and coaching for e.g. improving teamwork or upgrading processes 📄 Technical documentation writing 🔍 Process and technical documentation reviews 🔧 Consultation on tools and technologies related to Software as a Medical Device development, including Jira and Confluence administration 💬 Consultation on MDR and AI Act implementation and related standards 🎓 Training and speaking on these themes Most commonly applied standards: ISO 13485 IEC 62304 ISO 14971 IEC 62366-1 IEC 62366-2 IEC 82304-1 IEC 81001-5-1 We are ready to help even with the smallest issues, so don’t hesitate to contact us! If we cannot help you, we are happy to refer to other professionals and find the team you need for your projects!