Healthcare Software Development and Engineering Services

Decos provides healthcare software development services for MedTech companies, healthcare providers, diagnostics organisations, digital health innovators and life sciences businesses. We help design, build, integrate and modernise software in regulated environments, combining engineering expertise with a strong focus on quality and compliance.

Whether you are developing a new medical device, connecting healthcare systems or reengineering a legacy platform, our teams support you across the entire product lifecycle. As an ISO 13485-certified engineering partner, we deliver healthcare technology solutions with processes aligned to the demands of regulated healthcare and MedTech environments.

Full-Lifecycle healthcare engineering services

Healthcare technology requires precision across software, hardware, and regulatory frameworks. As an ISO 13485-certified partner, Decos solves complex technical challenges to help you launch compliant solutions faster and keep legacy platforms performing.

Core healthcare development and engineering services

Medical device engineering

Decos provides end-to-end medical device engineering services, supporting clients from concept and product development through testing, compliance, and commercialization. Our expertise spans mechanical and hardware design, embedded and software development, systems engineering, risk management, verification and validation, cybersecurity, and regulatory compliance. With experience across Class II and Class III medical devices, Decos helps develop safe, reliable, connected, and regulatory-ready products while supporting ongoing product lifecycle and remediation needs.

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Interoperability and integrations

Decos helps healthcare organizations connect medical devices, applications, and healthcare systems so they can communicate and exchange data seamlessly. We develop secure interoperability solutions using standards such as HL7 FHIR, HL7, DICOM, IHE, and CCDA, enabling efficient data exchange across diverse systems and platforms. From integrating with EHR/EMR systems to building custom data connectors, Decos helps create a connected healthcare ecosystem with reliable, secure, and real-time access to critical health data.

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Legacy modernization

Decos helps healthcare and medical device companies modernize and migrate legacy systems to secure, scalable, and future-ready platforms. We assess existing applications and architectures, identify risks and inefficiencies, and support application modernization, data migration, containerization, and system integration. By combining re-engineering expertise with healthcare and regulatory knowledge, Decos enables organizations to improve performance, interoperability, cybersecurity, and compliance while minimizing disruption to existing operations.

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Regulatory and compliance

Decos helps medical device companies navigate complex regulatory and quality requirements throughout the product lifecycle, from concept and development to commercialization and post-market support. Our services include DHF remediation, regulatory documentation, medical writing, QMS, risk management, and country-specific compliance. With expertise in standards such as ISO 13485, ISO 14971, IEC 62304, FDA requirements, and EU MDR, Decos helps reduce compliance risks, strengthen product quality, and accelerate market access.

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Product sustenance

Decos helps medical device and healthcare companies maintain, improve, and extend the lifecycle of their existing products. Our product sustenance services cover quality assurance, software updates and security, modernization, regulatory compliance, and obsolescence management. We address product issues, implement improvements, and manage evolving technologies and regulations to keep products reliable, secure, compliant, and relevant throughout their lifecycle.

Product remediation

Decos helps medical device and life sciences companies remediate outdated, incomplete, or non-compliant Design History Files (DHF). We identify documentation and compliance gaps, update technical documentation, and support verification and validation activities to align products with current FDA, ISO 13485, and other regulatory requirements. By combining regulatory, technical, and project management expertise, Decos streamlines remediation, reduces audit and compliance risks, and helps maintain market access.

Mechanical engineering

Decos provides end-to-end mechanical engineering support, from product design and CAD modelling to prototyping, testing, manufacturing, and product improvement. Our expertise includes new product development, plastics and product design, simulation and analysis, rapid prototyping, PLM, re-engineering, and sustaining engineering. We help healthcare, medical device, and technology companies solve complex engineering challenges, improve product performance, and bring high-quality products to market efficiently.

How we work

Every healthcare has different technical, regulatory and resource requirements. To accommodate your specific operational structure, we offer flexible engagement models, including dedicated engineering teams, project-based delivery, and targeted staff augmentation.

No matter which model you choose, our work is executed under strict processes aligned with ISO 13485 quality management standards. This ensures total transparency, consistent documentation, and predictable code quality at every stage of the development lifecycle.

Our approach to a collaboration

DISCOVERY

Prioritize features, technical debt, risks, regulatory activities, and product backlog items

IDEATION

Explore architectures, workflows and feasibility options.

IMPLEMENTATION

Build software, firmware, hardware support and test automation.

VALIDATION

Execute V&V, risk updates, usability and compliance documentation.

SUPPORT

Sustain releases, obsolescence, analytics and continuous improvement.

WHY DECOS

Engineering expertise for regulated healthcare innovation

Healthcare and medical device expertise

We understand the complexities of healthcare technology, from embedded systems and firmware to medical software, cloud platforms, and connected devices.

Regulatory-driven engineering approach

Our teams work within established quality frameworks, supporting compliance with standards such as ISO 13485, IEC 62304, ISO 14971, FDA requirements, and EU MDR expectation

End-to-end product engineering capabilities

From concept and architecture to development, verification, validation, and product sustenance, we support the complete product lifecycle.

Seamless collaboration with your teams

We work as an extension of your engineering organization, bringing specialized expertise while adapting to your processes, tools, and business goals.

FAQs

What healthcare software development services does Decos provide? Decos provides end-to-end healthcare software development services, including medical device software engineering, embedded software development, cloud-based healthcare applications, interoperability solutions, testing, verification and validation, and product modernization.

Does Decos support medical device software development?

Yes. We support medical device manufacturers with software engineering across the product lifecycle, including software architecture, embedded development, SaMD development, verification and validation, cybersecurity, and regulatory documentation support.

Is Decos experienced with healthcare regulatory standards? Yes. Our engineering processes are aligned with healthcare industry standards and regulatory expectations, including ISO 13485, IEC 62304, ISO 14971, FDA pathways, and EU MDR requirements.

Can Decos help modernize legacy healthcare systems and medical devices? Yes. We help organizations modernize existing products and platforms through software re-engineering, cloud migration, architecture improvements, interoperability enhancements, and lifecycle support.

HEALTHCARE SOFTWARE & ENGINEERING DEVELOPMENT SERVICES