Business Details
14 Years
experience
Trusted Medical Device Engineering & Development
Outer Reef Technologies delivers engineering and technical solutions that address client needs through innovation, cost-effectiveness, professionalism, and quality service. Our approach integrates exceptional design, verified results, and proven performance. We specialize in medical product development, ABB robotics, electronics, firmware, software, mechanical design, QA/RA support, and medical device manufacturing. Operating under an ISO 13485-compliant quality management system, we provide end-to-end support from initial concept to commercialization. Our expertise extends to regulatory requirements, ensuring tailored, cost-effective plans for FDA/EU/CE submissions. With decades of experience, we transitioned from prototyping to full production line support for complex electro-mechanical systems.Our focus on manufacturability ensures compliance with industry standards, while prioritizing communication, quality, schedules, and budgets. Client testimonials highlight our ability to adapt, innovate, and deliver reliable solutions. Our team collaborates with partners like ABB Robotics to develop cutting-edge surgical and automation technologies. We emphasize transparency, ethical practices, and long-term client relationships, supported by technical expertise in fields ranging from virtual reality to high-precision encoders. Our mission remains rooted in solving complex problems and advancing medical technology through systematic understanding and data-driven decision-making.
Services
Medical Device Development
Robotics
Electronics
Firmware
Software Design
Mechanical Design
Regulatory Assurance
Quality Assurance
Motor Controllers
Surgical Navigation
Details
- Year established: 2012
Highlights and features
- We provide end-to-end medical device development from concept to commercialization.
- Our team excels in ISO 13485-compliant quality management systems.
- We solve complex engineering challenges with data-driven decision-making.
- Our engineers prioritize communication, quality, and budget adherence.
- We partner with ABB Robotics for advanced automation and surgical solutions.
Associations and certifications
- ISO 13485
What people say
Exceptional ingenuity
Huge competitive advantage
Knowledgeable team
Timely deliverables
Innovative solutions
Services
Medical Device Development
We specialize in end-to-end medical device development, from initial concept to commercialization. Our ISO 13485-certified team ensures regulatory compliance through FDA/EU/CE submissions, prototyping, and full-scale production. We focus on manufacturability, precision, and innovation for complex electro-mechanical systems.
Robotics
As ABB Robotics partners, we develop surgical and industrial robotic platforms from the ground up. Our expertise includes motion capture, sensor calibration, and integration for medical and automation applications. We deliver solutions for precision-driven environments.
Firmware
We design custom firmware for medical devices and BLDC motors, ensuring reliability and performance. Our solutions include sensorless control, energy efficiency, and compliance with industry standards for seamless integration into complex systems.
Regulatory Assurance
We provide ISO 13485-compliant quality management systems, regulatory testing, and submissions (FDA/EU/CE). Our team develops cost-effective plans to meet regulatory requirements, ensuring market readiness for medical devices and production lines.
Mechanical Design
Using SolidWorks and FEA, we create mechanical components optimized for production. Our designs undergo 3D printing and simulation testing to ensure compliance with regulatory standards and functional requirements for medical and industrial applications.
People
Jonathan Azevedo
CEO and Founder
Jonathan founded Outer Reef Technologies in 2012 after pioneering self-driving cars and medical robotics. With a background in mechanical and robotics engineering, he specializes in data-driven solutions and has led teams in DARPA challenges. He mentors in FIRST Robotics and focuses on innovation.
Questions
What industries do you serve?
We primarily serve healthcare, robotics, and automation industries, with expertise in medical device development and ABB Robotics integration.
Are you ISO 13485 certified?
Yes, we operate under an ISO 13485-compliant quality management system for medical device development.
What regulatory services do you offer?
We assist with FDA/EU/CE submissions, quality management systems, and regulatory testing for medical devices.
What engineering services do you provide?
We offer mechanical design, firmware, software, and systems engineering for medical and automation applications.
Do you partner with ABB Robotics?
Yes, we are proud ABB Robotics partners, handling medical applications and automation solutions.
How do you ensure product quality?
We use FEA simulations, 3D printing, and ISO-compliant testing to validate designs before production.
