Optimize Your Medical Device Development
As the healthcare sector embraces more innovative medical devices, IT decision-makers face a range of engineering challenges. At Decos, we help solve these complexities through cutting-edge systems engineering services that streamline the development process while ensuring safety, compliance, and reliability.
Overcome Key Engineering Challenges
1. Design and Development
Translating requirements into a functional device involves intricate integration of hardware, software, and user interfaces.
Solution: Decos utilizes an iterative design process, refining prototypes based on feedback and testing, ensuring efficient development of hardware, software, and user interfaces.
2. Technical Design Reviews
Identifying potential design flaws and inefficiencies early in the development process is essential to avoid costly rework and delays.
Solution: Our technical design reviews are thorough and systematic, involving cross-functional teams to provide diverse perspectives.
3. Regulatory Compliance
Navigating complex regulations such as FDA, EMA, and regional standards can delay development.
Solution: Decos has deep expertise in regulatory requirements and ensures compliance with thorough documentation and timely approvals.
4. Human Factors Engineering
Ensuring devices are user-friendly for healthcare professionals and patients.
Solution: Decos prioritizes ergonomics and usability by engaging in regular user testing and feedback, ensuring devices are intuitive and effective in real-world settings.
5. Interoperability and Integration
Seamless integration with existing healthcare systems is necessary for data exchange and coordinated care.
Solution: Decos leverages best practices in system integration, ensuring devices communicate efficiently with other devices and healthcare IT systems.
By addressing these challenges, Decos helps medical device developers streamline the engineering process, ensuring safety, regulatory compliance, and innovation.
At Decos, we understand the complexities of system engineering in the healthcare sector. By combining technical expertise with a thorough understanding of your unique needs, we provide robust solutions that ensure safety, compliance, and efficiency. Whether it's overcoming regulatory hurdles, ensuring seamless device integration, or optimizing design verification, Decos is your trusted partner for every stage of the engineering lifecycle.
Build Complex Medical Systems with Confidence
From requirements to validation — we ensure seamless system integration.
Devesh Agarwal
Director, Decos India
Explore Our Systems Engineering Expertise
Need End-to-End Systems Engineering Support?
Accelerate development with our proven healthcare domain knowledge.
Robin Tummers
Product Owner Sales & Marketing
+34 680428830
OUR PROJECTS /WORK
The possibilities are endless. Our custom system engineering projects span various domains, demonstrating our expertise in delivering tailored solutions that address unique industry challenges and requirements. Here are some examples:
Remediation
Remediation
Remediated Class I, II & III medical device products including design planning, risk management, design input & output, verification & validation, and design transfer.
Biocompatibility
Biocompatibility
Consultation relating to tests required for the product and Labs
Human Factor Analysis
Human Factor Analysis
Includes use specification, task analysis, usability engineering, Usability Validation, and a detailed HFE report.