Business Details
Medical Device Development Experts
We are a multidisciplinary team of experts dedicated to transforming medical device development through innovation and precision. With over 30 years of combined experience, our team specializes in end-to-end product development, leveraging cutting-edge technology to address mission-critical challenges in the medical industry. Our approach integrates user-centered design, systems engineering, and regulatory compliance to deliver safe, effective, and market-ready solutions.We pride ourselves on fostering a culture of collaboration, creativity, and technical excellence, ensuring every project aligns with client goals and industry standards. Our global presence and diverse skillsets enable us to tackle complex challenges, from ideation to manufacturing, while maintaining a commitment to quality and client satisfaction.
Services
User-Centered Design
Industrial Design
Usability Engineering
Systems Engineering
Mechanical Engineering
Software Engineering
Design Transfer
Regulatory Compliance
Human Factors Testing
Product Prototyping
Highlights and features
- We have over 30 years of experience in medical device development.
- Our team includes ISO 13485-certified professionals with global regulatory expertise.
- We offer end-to-end solutions from ideation to manufacturing.
- Our multidisciplinary approach ensures holistic, user-centered design.
- We specialize in AI-driven and FDA-compliant medical technologies.
Associations and certifications
- ISO 13485:2016
Services
User-Centered Design
Our user-centered design approach prioritizes end-user needs through iterative research, feedback, and testing. We create intuitive, emotionally resonant medical devices that enhance usability and safety. By integrating human factors evaluations, we ensure compliance with FDA and global regulatory standards while differentiating products in competitive markets.
Systems Engineering
We deliver robust systems engineering solutions for complex medical devices, ensuring seamless integration of mechanical, electronic, and software components. Our team adheres to rigorous verification and validation protocols to meet quality standards, enabling reliable performance in high-stakes healthcare environments.
Regulatory Compliance
Our regulatory experts guide clients through FDA 510(k), ISO 13485, and global compliance requirements. We specialize in audit preparation, documentation, and submissions, ensuring medical devices meet stringent quality and safety benchmarks for market approval.
AI-Driven Medical Software
We develop AI-powered Software as a Medical Device (SaMD) solutions compliant with ISO 62304 standards. Our platforms leverage machine learning for diagnostics, patient monitoring, and treatment optimization, combining cybersecurity with user-friendly interfaces for healthcare providers.
Product Prototyping
Our in-house prototyping facilities utilize advanced tools like 3D printing and CNC machining to accelerate medical device development. We enable rapid iteration and testing, reducing time-to-market while maintaining precision and adherence to manufacturing constraints.
People
Darren Saravis
CEO
Darren founded Nectar and BreathDirect, driving innovation in medical device development through technology and design. He leads with a vision to improve global healthcare through interdisciplinary collaboration and cutting-edge engineering solutions.
John Duval
Principal Engineer
John has over 30 patents and specializes in product architecture and design for manufacturing. As a founding member of Nectar, he shapes engineering excellence through holistic, variable-aware solutions for complex systems.
Bryan Chan
Senior AI and Software Architect
Bryan leads AI-driven medical technology development, including FDA-compliant platforms for disease detection. He specializes in regulatory pathways, team leadership, and scalable MedTech solutions with ISO 62304 compliance expertise.
Stefanie Ng
Regulatory & Quality Expert
Stefanie has over a decade of experience in global regulatory affairs, managing FDA submissions and audits across the US, EU, and Asia. She helps clients navigate compliance with strategic, creative solutions for medical devices and pharmaceuticals.
Adam Marten
Senior Mechanical Engineer
Adam brings aerospace and consumer product expertise to medical device development. He specializes in structural analysis, product qualification, and cross-industry innovation, ensuring robust engineering solutions for complex applications.
Questions
What industries do you specialize in?
We focus on medical device development, including diagnostics, wearables, drug delivery systems, and healthcare IoT technologies.
How do you ensure regulatory compliance?
Our ISO 13485-certified processes and regulatory experts handle FDA submissions, audits, and global compliance strategies for medical devices.
Can you assist with AI-driven medical devices?
Yes, we develop FDA-compliant AI/ML platforms for diagnostics, patient monitoring, and treatment optimization with cybersecurity integration.
Do you offer prototyping services?
Our in-house prototyping lab uses 3D printing, CNC, and laser cutting for rapid medical device iteration and testing.
How is your project management structured?
Certified project managers use hybrid methodologies to ensure alignment with timelines, budgets, and client goals during device development.
Reviews (2)
Andrew Hill
Apr 09, 2020
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I ordered your IPAD ACTIVE COOLING CASE DUAL SUCTION MOUNT KIT for my iPad Mini 5 on Sunday June 9th. Your website claimed that it would take 2 days for processing and to be shipped. I emailed you on 6/11 asking if it was too late to cancel my order. I again emailed you on the 14th asking if it had been shipped yet with no response. I'm sure you'll say you didn't get the emails. It was finally shipped on Tuesday June 18th 6 business days later.
I had a flight trip planned for Tuesday the 18th and would have liked to use it then. The box was delivered on Friday the 21st with no hardware to connect the mount to the case. Hopefully the case will exceed my expectations because I'm not very impressed at this point with your customer service.
I had a flight trip planned for Tuesday the 18th and would have liked to use it then. The box was delivered on Friday the 21st with no hardware to connect the mount to the case. Hopefully the case will exceed my expectations because I'm not very impressed at this point with your customer service.
Cardio By U. U.
Nov 20, 2019
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Nectar, you made our dream come true. We sincerely thank you for all you have done for us. We want to extend our thanks to the CEO of Nectar Darren Saravis for his highly professional handling of our development of the "Cardio by U" treadmill. The whole team's knowledge, communication and attention to detail made this a truly pleasurable unforgettable experience. Nectar exemplifies how a product development company should conduct themselves. We highly recommend them to anyone looking to make their invention and dreams a reality.
