MEDICAL Devices

We deliver software development services for the design of complex, reliable and standards-compliant medical device platforms.

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A STRATEGIC R&D PARTNER

Medical device companies face multiple challenges in order to achieve successful market access. They need to keep constant focus on product innovation and strict safety regulations to develop next-generation, certified products. At the same time, long product life cycles require them to maintain legacy investments through moderate feature growth.

By partnering with Enea, vendors of medical devices benefit from proven experience in managing complex R&D projects with multiple technical and regulatory requirements and delivering reliable testing systems and QA services.

REFERENCES

Enea Global Services has accelerated the development of a variety of medical devices. Recent projects include:

  • Infusion pumps
  • Cancer detection solution

Our experts develop software platforms and solutions for high-tech, connected medical devices that improve telemedicine capabilities and patient treatment, and leverage the latest technologies:

  • Artificial intelligence
  • Augmented reality
  • IoT & wearables

CUSTOMER CASE: High-Performance Infusion Pumps

To increase the performance of its medical infusion pumps, the customer needed a new scalable hardware and software infrastructure capable of managing and monitoring the pumps in a faster and easier way.

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MEDICAL INDUSTRY EXPERIENCE

In addition to regulatory requirements, medical devices must also fulfil the requirements of patients, healthcare professionals and other medical system providers. Certifying software to comply with medical standards is a complex process that involves reviewing the software design, coding, validation and verification.

Enea’s professional services engineers have extensive experience in software engineering for some of the most demanding sectors: telecommunications, networking, avionics. They know how to meet stringent requirements for quality, standards fulfillment and performance, and bring significant value to the medical device market. Working on various projects for leading medical device vendors, they have also built a deep understanding of the healthcare sector and developed an open collaboration with key players in the industry.

LINUX & REAL-TIME OPERATING SYSTEMS

Linux & RTOS Development & Porting

  • Networking and Communication Engineering
  • Middleware and Application Development,
  • Drivers & BSP, Kernel

TESTING & VALIDATION

  • Testing & Validation, Customized/Automated Testing Frameworks for Class II and III Software & Devices
  • Test Script Development
  • Functional, Performance, Unit and System Testing and Validation

STANDARDS & CERTIFICATION

  • Class II and III Device w/Agile
  • Software Architecture Audit and Analysis
  • Compliance Guidance & Medical Standards (e.g. MDD, FDA 510(k), IEC 62304)
  • Test-driven Development

featured resources

CUSTOMER case: INFUSION PUMPS

New scalable software platform for high-performance medical infusion pumps

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CUSTOMER case: Robotic Surgery

Linux and real-time operating system platform for advanced robotic surgery

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RUNTIME SOLUTIONS FOR MEDICAL DEVICES

Robust and innovative real-time operating system solutions and embedded Linux for intelligent high-end medical devices

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VIDEO: Enea SERVICE DIFFERENTIATION

Enea Global Services’ 3 differentiators to offer a unique customer experience

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TALK TO AN EXPERT

Combining technical excellence, high quality and innovation, Enea provides best in class medical system design, development, testing and validation services.

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