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

SaMD

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!

Contact us today!

our projects related to SAMD

 

AI in Audiology
3D ear scanning

Development of 3D ear scanning application

audiology
Audiometer

Development of HIPAA compliant audiometer

electro studying
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.

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.

Read the blog
SaMD
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

Watch the recording
biocompatibility testing

Whitepaper: BIOCOMPATIBILITY TESTING OF MEDICAL DEVICES

Our comprehensive guideline for biocompatibility testing of medical devices, ensuring safety and regulatory compliance in healthcare innovations.

Read this whitepaper

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.

Send an email

Devesh
Devesh Agarwal
Decos