Collaborative Product Development
Our advanced manufacturing unit allows us to produce high-quality eye care products while enabling us to partner with organizations to scale production and create cutting-edge solutions.
Our Manufacturing Vision
State-of-the-Art Manufacturing & Global Collaboration
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Our state-of-the-art manufacturing unit is central to this vision, combining the latest technology with rigorous quality control. This enables us to produce high-quality eye care products, including portable diagnostic devices and AI-powered solutions, designed to deliver precise and reliable results.
Collaboration extends beyond our walls. By partnering with global healthcare organizations, research institutions, and technology innovators, we're able to scale production, enhance accessibility, and drive the development of breakthrough solutions that improve patient care worldwide.
Scale Production
Enhance Accessibility
Drive Innovation
Improve Patient Care
Our Advantages
Why Choose Forus
Driving Innovation, Ensuring Quality, Delivering Impact
Innovation drives Forus Health, with 7 granted patents and 12 in progress, enabling us to tackle challenges early and lay a strong foundation for success.
With a presence in 65+ countries and impacting 16 million lives, we leverage our global reach to navigate regulatory landscapes and accelerate market entry.
We meet stringent quality standards, including ISO 13485, MDSAP, and 21 CFR 820, minimizing process risks and ensuring your products meet global regulatory requirements.
Our advanced machining, 3D printing, and production facilities speed up development with rapid prototyping, quick design iterations, and streamlined production, ensuring faster time-to-market and high-quality standards.
Our global footprint provides insights into diverse user needs, enabling us to develop practical, effective products that meet international standards from the start.
Our clinical networks enable early feedback from leading clinicians, ensuring our products address both current and emerging healthcare challenges.
What We Offer
Partner with Forus Health to transform your ideas into impactful innovations, improving lives across the globe.
Everything you need to bring a medical device from concept to market
Product Design and Development
Transform your medical device ideas into reality with our all-in-one design services. From concept to completion, we bring innovation and precision to every step.
- Market Research to identify trends and user needs
- Mechanical, optical, software & electronics design
- Risk management & product verification
- DFM/DFA and iterative prototyping
Supply Chain Management
Seamlessly manage components and materials with efficient strategies.
- Custom optical, molded & electronic component solutions
- Strong vendor relationships and global sourcing
- Real-time inventory management
Precision Component Manufacturing
Produce high-accuracy components tailored to your needs.
- Advanced CNC machining for intricate geometries
- 3D printing for rapid prototyping & small-batch production
- Rigorous quality assurance to meet precise specifications
Medical Product Assembly
Comprehensive assembly services to deliver finished medical devices.
- ISO 13485-certified facilities with Class 10,000 cleanrooms
- In-house safety testing and verification
- Full traceability with Device History Record (DHR) systems
Product Compliance
Ensure devices meet global safety, quality, and performance standards.
- Validation testing for electrical safety & biocompatibility
- Software as a Medical Device (SaMD) compliance expertise
- Tailored solutions for AI-driven and IoT-enabled devices
Clinical Evaluations and Investigations
Evaluate the safety and performance of your device.
- Support for clinical trials, from planning to execution
- Data collection and analysis for regulatory requirements
- Preclinical, feasibility & post-market evaluation guidance
Regulatory Intelligence and Affairs
Simplify complex regulatory processes with expert guidance.
- Global certifications — EU MDR, US FDA, ISO 13485
- Regulatory requirements integrated during development
- Real-time monitoring of evolving compliance standards
Software as a Medical Device (SaMD) & AI
Leverage advanced technologies with comprehensive support.
- Usability testing & cybersecurity measures for SaMD
- Clinical validation for AI-based medical devices
- Guidance on managing updates while maintaining compliance
Post-Market Surveillance
Maintain safety and compliance after market launch.
- Proactive risk management and continuous monitoring
- Periodic evaluations to adapt to evolving regulations
- Real-world data collection to enhance device performance
Manufacturing Capabilities
Medical Product Assembly
End-to-end assembly backed by certified quality systems
Product Verification
Rigorous testing and inspection against ISO 13485, FDA, and GHTF standards.
- Incoming material quality control
- Precision testing vs. design specs
- CAPA tracking for transparency
Packaging & Storage
Designed for safety, durability, and long-term compliance.
- Rugged packaging for safe transit
- Long-life, environment-resistant labeling
- Controlled storage conditions
Procurement & Supply Chain
Optimized sourcing and inventory for efficiency and speed.
- Global supplier network
- ERP-driven inventory management
- Continuous supplier quality monitoring
Seamless Logistics
Fast, reliable delivery powered by a global partner network.
- Streamlined fulfilment pipelines
- Strong national & international partnerships
Advanced Machining
Precision Component Manufacturing
State-of-the-art machining capabilities for high-accuracy medical components
Advanced CNC Machining
State-of-the-art CNC turning, milling, and turn-mill centers delivering highly accurate, repeatable components at any scale.
Precision Engineering
Expert machining across metals (aluminum, stainless steel, titanium) and composites — tailored to unique project requirements.
Multi-Axis Machining
Multi-axis CNC machines enable complex contouring, drilling, threading, and profiling on intricate geometries in a single setup.
Custom Prototyping & Production
Rapid prototyping and scalable high-volume production to meet all project timelines and volume demands without compromise.
Quality Assurance
Advanced inspection equipment and strict quality controls verify every specification is met throughout the manufacturing process.
Got Questions?
Frequently Asked Questions
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We develop device-specific strategies, using a requirement-driven approach that combines innovation with regulatory compliance.
We streamline workflows and eliminate bottlenecks to enable faster product launches.
Our facilities provide end-to-end medical device manufacturing, including cleanroom assembly, precision CNC machining, 3D printing, and advanced testing—ensuring high-quality, compliant, and scalable production.
We offer comprehensive support from concept to regulatory compliance.
We mitigate supply chain risks through diversified sourcing, strong supplier partnerships, in-house manufacturing capabilities, and stringent quality control measures.
Yes, we deliver custom solutions through specialized supplier collaborations.
We comply with ISO 13485, 21 CFR, MDSAP, and other global QMS standards and regulations, ensuring safe, reliable, and controlled cleanroom assembly for medical devices.
We ensure seamless regulatory compliance for SaMD and AI-based devices by integrating AI-specific frameworks and applying rigorous clinical validation, risk management, cybersecurity, real-world performance monitoring, and adherence to ISO 13485, IEC 82304, and other relevant standards.
We support clinical evaluations and investigations by designing study plans and protocols, facilitating data acquisition, and managing regulatory submissions in collaboration with Independent Ethics Committees (ECs) and hospitals for clinical trials.
With a regulatory footprint spanning 65+ countries, we have successfully navigated complex global approvals across the USA, EU, MENA, APAC, and beyond. Our expertise ensures a seamless regulatory strategy, and swift approvals tailored to your market needs.
Our SaMD and AI regulatory solutions are built on a thorough understanding of global frameworks, including FDA, MDR, IMDRF, and AI-specific guidelines—and incorporate risk-based regulatory strategies.
We maintain ongoing product safety and performance through comprehensive Post-Market Surveillance (PMS) and vigilance systems that meet global regulatory standards and expectations.
