ENHANCING HEALTHCARE EFFICIENCY WITH ROBUST SAMD DEVELOPMENT
Welcome to Decos. We offer cutting-edge Software as a Medical Device (SaMD) to enhance personalized patient care. Our agile and secure software ensures reliability and maximizes value in the digital healthcare ecosystem.
We help medical device manufacturers navigate regulations, secure data, integrate with devices, and drive continuous innovation. With Decos, achieve compliance and deliver superior patient outcomes through advanced software solutions.
Are these challenges slowing down your progress?
1. Challenge: Regulatory Consulting
Solution: Expert regulatory consulting to help you meets all necessary regulatory requirements, including ISO 13485, EU MDR and US FDA standards to streamlining the approval process.
2. Challenge: Maintaining flexibility and efficiency in the development process
Solution: Application of Agile methods tailored for SaMD, enhancing development efficiency and responsiveness to changes.
3. Challenge: Risk Assessment
Solution: Comprehensive risk assessment to identify and mitigate risks, ensuring patient safety and regulatory compliance.
4. Challenge: Validation & Verification
Solution: Rigorous validation and verification processes to ensure your SaMD functions correctly and meets all specifications.
5. Challenge: Cybersecurity
Solution: Comprehensive cybersecurity testing to safeguard your SaMD against potential cyber threats, ensuring data protection, device functionality and device integrity.
6.Challenge: Interoperability
Solution: Provide interoperability services to ensure your software integrates smoothly with various medical devices and systems.
7. Challenge: Ensuring user-centric design and improved usability.
Solution: Integration of UX and Human Factors into development cycle
At Decos, we provide comprehensive SaMD development services that cover the entire product lifecycle, including user experience design, human factors integration, requirements definition, risk analysis, agile software development, and thorough verification and validation.
We assist you in building and advancing innovative SaMD, medical device software, and connected devices more quickly.
Ready to accelerate your SaMD development? Let's innovate together to revolutionize patient care. Contact us today to get started!
our projects related to SAMD
3D ear scanning
3D ear scanning
Development of 3D ear scanning application
Audiometer
Audiometer
Development of HIPAA compliant audiometer
Electrodiagnostic system
Electrodiagnostic system
Development of electrodiagnostic system used to measure nerve muscle function
INSIGHTS
Blogs, whitepapers, webinars – we're passionate about sharing our knowledge. Here's a glimpse of what we offer.
Blog: Driving Excellence in Healthcare and Medical Devices with Automation Testing
Blog: Driving Excellence in Healthcare and Medical Devices with Automation Testing
Discover how cutting-edge automation testing solutions are driving excellence in healthcare and medical devices.
Webinar: Electronic Medical Device Reliability
Webinar: Electronic Medical Device Reliability
Learn about enhancing the reliability of electronic medical devices through Decos's expert insights and strategies shared in their latest webinar
Whitepaper: BIOCOMPATIBILITY TESTING OF MEDICAL DEVICES
Whitepaper: BIOCOMPATIBILITY TESTING OF MEDICAL DEVICES
Our comprehensive guideline for biocompatibility testing of medical devices, ensuring safety and regulatory compliance in healthcare innovations.
Get in touch with our team
We are eager to assist you with your challenges and to inform you about our services. Please feel free to reach out by sending an email, calling us directly, or filling in your contact information if you would like to receive more information.
