Innovating Medical Device with Advanced Product and Systems Engineering Services
From concept to compliance, at Decos we ensure your medical device solutions are compliant, regulatory-ready, and future-proof - helping you bring safe, efficient, and high-performing medical technologies to market.
PRODUCT ENGINEERING SERVICES
Decos delivers end-to-end Product Engineering Services for medical devices, ensuring seamless integration of design, development, compliance, and testing. From concept to commercialization, we help you build market-ready, regulatory-compliant, and high-performance healthcare solutions.
End to End Product Development
End to End Product Development
End-to-end medical device development—from feasibility and usability studies to risk management and regulatory compliance.
Hardware Design
Hardware Design
Precision-driven electronics for medical devices—from circuit design and PCB layout to prototyping and compliance optimization.
Mechanical Design
Mechanical Design
Covers everything from conceptualization to final production, ensuring your device meets both performance and compliance standards.
Compliance to Standards
Compliance to Standards
Ensuring regulatory compliance for medical device including ISO, IEC, FDA, HIPAA.
Product Lifecycle Management
Product Lifecycle Management
Comprehensive product lifecycle management—ensuring DHF & DMR compliance, seamless documentation, and regulatory readiness for medical devices.
Engineering Change Request (ECRs)
Engineering Change Request (ECRs)
Managing changes in engineering documentation, product specifications, drawings, and other technical aspects.
Product Security Gap Assessment
Product Security Gap Assessment
Strengthening medical device security—ensuring compliance with FDA Cybersecurity Guidelines, EU MDR, and IEC 62304.
REACH & RoHS Management
REACH & RoHS Management
Environmental compliance made easy—ensuring REACH & RoHS adherence while maintaining product safety and integrity.
Reliability & Environmental Testing
Reliability & Environmental Testing
Ensuring device durability and reliability—through environmental stress, reliability, and failure analysis testing.
CAPA & RCA Activities
CAPA & RCA Activities
Proactive quality management—leveraging RCA and CAPA to resolve issues, enhance reliability, and ensure compliance.
Firmware Development
Firmware Development
We specialize in developing robust, efficient, and reliable firmware for a wide range of embedded systems.
Software Development
Software Development
Building medical software solutions—from secure development and modernization to EMR/EHR integration, advanced analytics, and rigorous testing for compliance and performance.
Audiologist (SME)
Audiologist (SME)
Bridging technology and patient care—our Audiologist SME ensures clinical accuracy, user-centric design, and regulatory compliance in medical device development.
EXPERTISE IN SYSTEMS ENGINEERING
At Decos, we specialize in Systems Engineering to develop high-performance, compliant, and interoperable medical devices. Our expertise ensures seamless integration of hardware, software, and connectivity, meeting strict regulatory standards while optimizing reliability and usability.
We are a ISO 13485 certified company supporting all Class II & Class III activities for NPI’s (New Product Implementation) and Remediation (FDA, MDD & EU-MDR), following ISO 13485, 14971 and IEC 62304.
Risk Management
Risk Management
Structured risk management ensures medical device safety, regulatory compliance, and a well-balanced risk-benefit approach for patient protection.
Biocompatibility Services
Biocompatibility Services
We offer comprehensive biocompatibility services to ensure your medical devices meet stringent regulatory requirements and prioritize patient safety.
Human Factors Analysis
Human Factors Analysis
Human Factors Engineering (HFE) and usability services to ensure your medical devices are safe, effective, and user-friendly.
Labelling and IFU
Labelling and IFU
We ensure medical device labels and IFUs are accurate, compliant, and user-friendly, meeting global regulations while minimizing labeling risks.
Packaging, Handling and Environmental Testing (PHET)
Packaging, Handling and Environmental Testing (PHET)
We conduct rigorous Packaging, Handling, and Environmental Testing (PHET) to ensure medical devices withstand real-world conditions, backed by detailed reporting.
V&V (Verification & Validation)
V&V (Verification & Validation)
We develop detailed design verification plans, protocols, and reports to demonstrate that the device's design outputs meet the design inputs.
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WHY CHOOSE DECOS?
- Decades of expertise in medical device engineering
- Deep understanding of FDA, EU MDR, and ISO compliance
- End-to-end support from concept to market
- Expertise across software, hardware, and compliance
Decos ensures that your medical device innovations are engineered for safety, compliance, and market success.
Partner with us to harness technology that fuels growth and innovation across your entire organization.
Let’s bring your next breakthrough medical product to life—connect with us today!
Suzanne van Tuijl - Mulder
COO Decos Global
+31621465570
Connect with us
Ensure your product’s success with Decos.
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Devesh Agarwal
Director Decos External Services