A World-Class Provider of Quality Driven Medical Software
Through our +25 years of experience, we help our customers to succeed with their software as part of medical device, software as a medical device and data-driven solutions – while taking all those specific requirements and the regulatory framework, that is applied to such medical devices, into account.
Digital healthcare is revolutionizing the future of healthcare. Both data-driven solutions and SW are playing important role in this enabling companies to create novel and preventive ways to deliver healthcare. More stringent requirements to medical SW, including MDR with new classification rule for SW, are almost here as well. Many company will face a situation where they have to re-define their practices and processes to survive in the regulative scrutiny.
At Innokas Medical, Quality Driven Medical SW thinking and Co-Creation are the core drivers for us in Medical SW business.
By “Medical SW” we cover the co-creation of your Software as part of Medical Device (Embedded SW), Software as a Medical Device (SaMD), or Data-Driven Healthcare application. By “Quality Driven” we want to highlight both the specific requirements and the regulatory framework that is applied to such medical devices – and which must be taken into account.
You have an idea of a Medical SW or Application? Let’s realize it together!
Co-Creation Approach Combined With
Quality Driven Medical Software Thinking
To achieve both agile co-creation and the regulatory compliance during the whole life cycle of the medical device, we’ve launched Innokas Medical’s flexible and scalable service center model including wide range of expertise to match the needs of Quality Driven Medical SW.
Thus, our customers are able to concentrate on their own core competences while Innokas Medical completes their expertise and know-how throughout the whole life cycle of their Medical Device Software and Application.
Innokas Medical as World-Class Quality Driven Medical Software Provider – Key Competencies and Services
Project Management Services
- On-target project implementation
- Agile execution and tooling
- Following FDA-requirements
- Following ISO 13485 requirements
- Design for Excellence (DfX)
Usability Design Services
- According to IEC 62366
- Focus on usability and ergonomics
- User interface and industrial design
Software Development Services
- According to IEC 62304
- Embedded SW
- User interface
- SW testing, automated testing
- UX and UI development
- IoT and connectivity
- Data analytics and AI/ML
- Ensuring compliance throughout the product life-cycle
Data Driven Solutions & Services
- Analytics & data science
- Front & back-end
- Web apps & mobile
- AI & machine learning
- Medical records & integration
- Connectivity & cloud
- Medical embedded SW & sensors
Innokas MedTech Design Studio in a nutshell
- Over 60 professional design resources in Finland and in Sweden
- Development projects according to ISO 13485 QMS and FDA QSR
- Application life cycle management throughout the development project for full requirement traceability
- Technical file (DMR, DHF) according to MDD / IVD / AIMD
- Understanding EU harmonized and FDA recognized standards
- Quality and Risk Management expertise
- Regulatory intelligence and submission experience