Medical device engineering Services

Developing a successful medical device requires more than software development. It demands expertise across software, firmware, hardware, systems engineering, verification & validation and regulatory engineering.

As an ISO 13485-certified engineering partner, Decos supports MedTech companies, medical device OEMs and healthcare organisations throughout the complete product lifecycle, from new product development and New Product Introduction (NPI) to product sustenance, remediation and long-term engineering support.

MEDICAL DEVICE SOFTWARE DEVELOPMENT

Software is at the heart of today's medical devices, from embedded applications and connected platforms to Software as a Medical Device (SaMD). Decos develops regulated software using engineering processes aligned with IEC 62304. Our medical device software development services include:

Desktop, web and cloud applications
HIPAA-compliant software development
Native and hybrid mobile applications
Re-engineering and modernization
Power BI dashboards and reporting
EMR and EHR integration
Standalone and enterprise healthcare applications
Functional, performance, reliability and security testing

PRODUCT AND SUSTENANCE ENGINEERING

Successful medical devices evolve long after their initial release. Decos supports both new product development and existing products through engineering services that improve performance, maintain compliance and extend product lifecycles.

Our engineering capabilities include:

Product development

New Product Development (NPD) and New Product Introduction (NPI)
End-to-end medical device product development
Product Lifecycle Management (PLM)

Product Sustenance

Product sustenance engineering
Engineering Change Requests (ECRs)
Product Security Gap Assessment
CAPA and Root Cause Analysis (RCA)

Regulatory Support

DHF and DMR support
Regulatory remediation
Audit support

EMBEDDED, FIRMWARE AND CONNECTED MEDICAL DEVICES

We develop software that enables reliable device performance and secure communication across healthcare environments.

Connected Medical Devices

We develop connected medical device solutions that enable data to move seamlessly between devices, healthcare applications and cloud platforms. Capabilities include:

IoMT (Internet of Medical Things)
Device-to-cloud connectivity
Wireless communication
EMR/EHR integration
Remote monitoring
Clinical system integration

Firmware Development

Our firmware engineering expertise includes:

Embedded C/C++
Embedded Linux
RTOS
Peripheral device drivers (SPI, I2C, UART)
USB
Wi-Fi
Bluetooth Low Energy (BLE)
Multi-device architectures

SYSTEMS ENGINEERING

Systems engineering brings together product requirements, usability, safety and compliance into a structured development process. Decos supports Class II and Class III medical device programmes for both New Product Introductions (NPI) and remediation projects.

DESIGN CONTROLS AND DOCUMENTATION

Design History File (DHF) creation and remediation
Product requirements
Requirements traceability
User manuals
Device and packaging labelling
UDI compliance

RISK MANAGEMENT

Aligned with ISO 14971, we support:

Risk management planning
Hazard identification
Risk analysis and evaluation
Risk control and mitigation
Risk-benefit analysis
Risk reporting

HUMAN FACTORS ENGINEERING

We help improve product usability through:

Use specification
Task analysis
Usability engineering
Formative testing
Usability validation
Human Factors reporting

BIOCOMPATIBILITY CONSULTING

Our services include:

Planning and assessment
PFAS review
Literature review
Natural Rubber Latex Evaluation
Laboratory report interpretation

HARDWARE AND MECHANICAL ENGINEERING

Medical device innovation depends on the seamless integration of electronics, mechanics and software. Our multidisciplinary teams support hardware and mechanical engineering throughout product development.

Hardware Design and Prototyping

Analog and digital electronics
Component selection
Circuit schematics
Multi-layer PCB design
Prototype development

Mechanical Engineering

Mechanical design and analysis
Material selection and qualification
Simulation and 3D modelling
Product database management
Production support

VERIFICATION, VALIDATION AND PRODUCT QUALITY

Verification and Validation (V & V) is integrated throughout development to demonstrate that products meet design requirements and regulatory expectations.

DESIGN CONTROLS AND DOCUMENTATION

Verification plans
Validation plans
Protocol development
Execution support
Verification and validation reports

SOFTWARE TESTING

Functional testing
Performance testing
Reliability testing

RELIABILITY AND ENVIRONMENTAL TESTING

Our engineering teams also support:

Reliability prediction
Reliability modelling
Derating analysis
Performance testing
Packaging, Handling and Environmental Testing (PHET)
Shock, vibration, altitude, humidity and temperature testing
PHET reporting

LABELLING, SAFETY AND ENVIRONMENTAL COMPLIANCE

We help ensure products meet global regulatory expectations through:

Labelling and IFU development
UDI management
Label verification and validation
EMI/EMC testing support
IEC 60601 compliance support
REACH and RoHS management

OUR LATEST PROJECTS

Audiology platforms

Decos has supported the design, development, verification, validation, compliance, and sustenance of advanced audiology and hearing-care solutions.

Biocompatibility tests

Supported biocompatibility assessments, reliability testing, IEC 60601 activities and FDA 510(k) documentation of implantable medical devices.

Medical device remediation

Updated verification protocols, validated hardware-software interactions and created Design History File (DHF) documentation for regulatory submissions.

Electrodiagnostic System Development

Development of electrodiagnostic system used to measure nerve muscle function, providing intra-operative monitoring

Remediation

Remediated Class I, II & III medical device products including design planning, risk management, design input & output, verification & validation, and design transfer.

WHY DECOS?

Engineering successful medical devices requires expertise across disciplines. Decos combines software, firmware, hardware, mechanical and systems engineering within an ISO 13485-certified quality management system to support the complete medical device lifecycle.

Whether you are developing a new product, modernising legacy technology or supporting post-market activities, we provide engineering services that help accelerate innovation while maintaining quality, compliance and long-term product performance.

FAQs

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What is Software as a Medical Device (SaMD)?

Software as a Medical Device (SaMD) is software intended to perform a medical purpose without being part of a hardware medical device. We develop SaMD solutions using structured software lifecycle processes aligned with IEC 62304.

Do you develop embedded software for medical devices?

Yes. We develop embedded firmware, connected medical device software and IoMT solutions that integrate with healthcare applications and clinical systems.

Is your development process ISO 13485 compliant?

Yes. Decos is an ISO 13485-certified engineering partner. Our development processes align with ISO 13485 design controls and recognised standards such as IEC 62304 and ISO 14971.

Can you help with verification and validation?

Yes. We support verification and validation throughout the product lifecycle, including planning, protocol development, execution, testing and reporting.

MEDICAL DEVICE ENGINEERING SERVICES

OUR ENGINEERING EXPERTISE INCLUDE