Our Services
Tailored Medical Device Solutions – From Ideation to Implementation
Concept Development
Our teams are not experts; they are learners with a passion for innovation. We foster an environment where curiosity thrives, allowing us to explore new ideas and push the boundaries of what’s possible in medical device development.
Manufacturing Support
We believe in aligning our culture with our clients’ success. That’s why our teams approach manufacturing support with a sense of ownership and accountability, ensuring that every aspect of the process is executed with precision and care.
Quality Assurance
Quality is not just a goal; it’s a fundamental part of our culture. Our teams are dedicated to upholding the highest standards of quality and safety, with a relentless focus on continuous improvement and customer satisfaction.
Design and Prototyping
With a sense of urgency driving us forward, we approach design and prototyping with determination and agility. Our teams are not satisfied with the status quo; they are driven to iterate quickly, learn from each iteration, and deliver results that exceed expectations.
Lifecycle Management
In a fast-paced industry like medical device development, time is of the essence. Our teams understand the importance of speed and agility, working tirelessly to deliver results with a sense of urgency while never compromising on quality.
Regulatory Compliance
Navigating the regulatory landscape requires more than just knowledge; it demands a commitment to staying ahead of the curve. Our teams embrace this challenge with enthusiasm, ensuring that our clients are always well-informed and prepared to meet regulatory requirements.
Electronics Engineering Services
01. Hardware Design
Our electronics engineering team specializes in designing hardware components for medical devices. This includes circuit design, PCB layout, component selection, and testing to ensure optimal performance and reliability.
02. Embedded Systems
We develop embedded systems that power medical devices, incorporating microcontrollers, sensors, actuators, and communication interfaces. Our expertise in firmware development ensures seamless integration and functionality.
03. Analog and Digital Signal Processing
Signal processing is crucial in medical devices for data acquisition, filtering, and analysis. Our engineers are skilled in designing analog and digital signal processing algorithms tailored to specific medical applications.
04.Wireless Connectivity
Many modern medical devices rely on wireless connectivity for data transmission and remote monitoring. We have experience in designing RF and wireless communication systems compliant with regulatory standards.
Software Engineering Services
01. Embedded Software
Our software engineers develop embedded software that controls and interfaces with hardware components in medical devices. This includes real-time operating systems, device drivers, and firmware updates.
02. User Interface (UI) and User Experience (UX) Design
We focus on creating intuitive and user-friendly interfaces for medical devices, considering factors such as usability, accessibility, and regulatory requirements.
03. Software Validation and Verification
Ensuring software reliability and compliance is critical. We conduct rigorous validation and verification testing, including software unit testing, integration testing, and system testing, to meet regulatory standards.
04. Cybersecurity
With cybersecurity threats on the rise, we implement robust security measures in medical device software, including encryption, authentication, and data protection, to safeguard patient information and device integrity.
Mechanical Engineering Services
01. Product Design and Development
Our mechanical engineers collaborate with electronics and software teams to design innovative medical devices. This includes CAD modeling, prototyping, and testing for functionality, ergonomics, and manufacturability.
02.Materials Selection
We help choose materials that meet regulatory requirements, are biocompatible, and offer durability and performance for medical device components and enclosures.
03. Manufacturing Support
From design for manufacturing (DFM) to production optimization, our mechanical engineering services ensure seamless transition from prototyping to mass production while maintaining quality and cost-effectiveness.
Systems Engineering Perspectives
01. Interdisciplinary Integration
Systems engineering integrates electronics, software, and mechanical components into a cohesive system. Our systems engineers ensure that all subsystems work together harmoniously, meeting functional requirements and user needs.
02. Risk Management
Systems engineers assess and manage risks throughout the system lifecycle, aligning with standards such as ISO 14971. This includes identifying hazards, evaluating risks, and implementing mitigation strategies to ensure safety and reliability.
03. Regulatory Compliance
Systems engineering takes a holistic approach to regulatory compliance, considering not only individual components but also system-level requirements and standards such as ISO 13485 and IEC 60601 series.
04. Lifecycle Management
Systems engineers oversee the entire lifecycle of medical devices, from concept development to post-market support. This includes requirements management, configuration control, and continuous improvement to enhance product quality and performance over time.
Get in Touch
Ready to experience the difference? Contact us today to learn how we can support your medical device development needs.