Precision in every component, innovation in every device.
We help medical device companies develop innovative, high-quality, and cost-efficient solutions by combining deep domain expertise with advanced software and hardware engineering. Our capabilities support product innovation, software-hardware integration, regulatory compliance, and secure cloud-based functionalities, ensuring reliable and efficient medical device development.
.jpg)
.jpg)
Target Markets
.jpg)
.jpg)
.jpg)
Business & Technical Priorities of Target Companies
At Enlight Engineering, we understand the challenges faced by medical device manufacturers, including:
- Lack of knowledge in specific technical domains.
- Insufficient capacity to handle complex projects.
- Limited expertise in hardware and software development, especially regarding domain-specific requirements.
- The need for cost-efficient and high-quality solutions.
- Demands for product innovation and regulatory compliance in a competitive landscape.
Hardware Design and Optimization
- Incorporating new functionalities, advanced wireless communication, and compact designs suitable for integration into wearable systems.
- Optimizing devices for ergonomics, mobility, power efficiency, and seamless software-hardware integration.
Data Security and Cloud Integration
Ensuring secure wireless communication and optimized cloud-based functionalities for real-time monitoring and analytics.
Soft and Hard Real-Time Systems
Scope of Offerings
Feasibility Studies
Before investing in full-scale development, a feasibility study assesses both the technical and economic viability of a medical device concept. This includes:
- Technical feasibility – Evaluating whether the device can be developed with existing technologies or if new innovations are required.
- Regulatory feasibility – Identifying potential compliance challenges related to ISO 13485, IEC 60601, FDA, and MDR.
- Cost estimation – Assessing development costs, manufacturing scalability, and expected return on investment.
Concept Development
This phase involves brainstorming different approaches, selecting appropriate technologies, and creating preliminary design sketches or CAD models. Additionally, a risk analysis is conducted to identify potential design challenges early, preventing costly modifications later in development.
Prototyping
This phase focuses on evaluating performance, usability, and technical feasibility while identifying potential design improvements.
Small-series production
Once the prototype is validated, small-series production allows for pilot studies, clinical trials, and market testing before mass production. Benefits include:
Limited batch manufacturing – Producing devices in small quantities to refine design and test scalability.
Real-world validation – Allowing healthcare professionals and patients to use the device in controlled settings.
Regulatory preparation – Gathering data for FDA/MDR approval, CE marking, and ISO 13485 certification.
Design for Manufacturing (DFM)
This process involves refining the design to minimize material waste, simplify assembly, and enhance manufacturability while maintaining performance and compliance with industry standards.
Regulatory Compliance
Medical devices must comply with strict international regulations to ensure safety, effectiveness, and reliability. Key compliance activities include:
ISO 13485 (Medical Device QMS) – Establishing quality management systems for development and manufacturing.
IEC 60601 (Electrical Safety in Medical Devices) – Ensuring safe operation of electronic medical equipment.
ISO 14971 (Risk Management) – Identifying and mitigating potential patient and operator risks.
IEC 62304 (Medical Software Development) – Ensuring safe and effective medical software lifecycle management.
Preclinical and clinical validation – Conducting safety and efficacy tests before regulatory submissions.
Services
.jpg)
PCB Design and Layout
We design high-performance PCBs for medical devices, ensuring safety, efficiency, and compliance with IEC 60601 standards.
.jpg)
Bare-Metal Embedded Systems Development
We develop bare-metal firmware for medical devices, enabling ultra-low latency, efficient power use, and reliable performance—ideal for implants, neurostimulators, and diagnostics.4o
.jpg)
Hardware Prototyping & Hardware/software integration
We offer sensor integration, battery optimization, and enclosure design to build functional, production-ready prototypes.
Our team integrates hardware and software for medical devices, ensuring seamless sensor-to-cloud communication, low latency, and ISO 27001-compliant data security.
.jpg)
Embedded and Software Development
We develop higher level embedded software and medical software optimized for reliability, safety, and efficiency. Complex algorithms for real-time diagnostics, we ensure smooth operation and intuitive user interaction.
.jpg)
IoT and Smart Device DevelopmenT
We enable medical devices to be smart and connected by integrating IoT technologies. Our solutions include remote patient monitoring, real-time alerts, and predictive maintenance using secure wireless protocols (BLE, Wi-Fi, LoRa, NB-IoT) while ensuring compliance with medical data protection regulations.
.jpg)
Cloud Solutions and Business Logic & Data Analysis for Predictive Insights
Our services include cloud infrastructure setup, data storage, processing, business logic development, and predictive analytics—enabling smart, connected medical devices with real-time monitoring and performance insights.
Technology & Equipment Stack
We leverage industry-leading platforms and tools to deliver state-of-the-art solutions:
EDA Tools
- Altium Designer
Embedded OS
- FreeRTOS, and higher-level OS-based solutions
Microcontrollers
- ATX Mega, ARM Cortex, PIC, STM32
Architectures
- ARM Cortex
Hardware Platforms:
- Silicon Labs, ESP32
Browse Case Studies
Key benefits
Software partner with strong domain know-how
Having a software partner that has complete know-how (technologies, best practices, processes, standards...) and software engineering capabilities for flexible, reliable &cost-efficient development of solutions in the medical devices sector.
End-to-end solutions
From feasibility studies and prototyping to manufacturing and regulatory compliance, ensuring a smooth development process.
Value/Investment optimization
Competitive value/investment ratio compared to Western European companies offering similar services.
What can we do for you?
Contact us to share ideas.
