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.
State-of-the-Art Manufacturing
At Forus Health, 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 Beyond Borders
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.
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How MPMRS Empowers Your Product Development
At MPMRS, we understand that every product and its development journey is unique. That’s why we offer tailored solutions to help you bring innovative products to market efficiently, while ensuring compliance and quality.
Why Choose MPMRS?
Customized Approach for Your Product: We customize strategies to your product’s needs and development stage, blending innovation with compliance for optimal results
Maximized Efficiency: Our dedicated teams handle multiple activities in parallel, significantly reducing the need for additional resources, time, and effort—helping you save money while accelerating progress.
Faster Time-to-Market: Through a structured approach, we identify key milestones, eliminate delays, and avoid obstacles, helping you launch faster without compromising quality.
Thorough Design Reviews: Our comprehensive design reviews ensure adherence to key guidelines from the start, minimizing late-stage flaws, delays, and costly changes.
Integrated Risk Management: By incorporating risk management early and robust testing protocols, we ensure your product meets safety standards, providing confidence in its reliability and performance.
Optimized Manufacturing Readiness: Our expertise in Design for Manufacturing (DFM) and Design for Assembly (DFA) ensures that mass production is streamlined right from the beginning, reducing inefficiencies and avoiding production bottlenecks.
Leverage Existing Infrastructure: Leverage our established manufacturing, production, and testing facilities to save time and resources, avoiding costly setups.
Why Choose Forus
Driving Innovation, Ensuring Quality, Delivering Impact
A Proven Legacy of Innovation
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.
Global Expertise for Seamless Market Entry
With a presence in 65+ countries and impacting 16 million lives, we leverage our global reach to navigate regulatory landscapes and accelerate market entry.
Certified Excellence
We meet stringent quality standards, including ISO 13485, MDSAP, and 21 CFR 820, minimizing process risks and ensuring your products meet global regulatory requirements.
Advanced Manufacturing Capabilities
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.
Understanding Global Needs
Our global footprint provides insights into diverse user needs, enabling us to develop practical, effective products that meet international standards from the start.
Collaborations with Clinical Experts
Our clinical networks enable early feedback from leading clinicians, ensuring our products address both current and emerging healthcare challenges.
Partner with Forus Health to transform your ideas into impactful innovations, improving lives across the globe.
Product Design and Development
Transform your medical device ideas into reality with our all-in-one Product Design and Development services. From concept to completion, we bring innovation and precision to every step.
Market Research: Market research to identify trends and user needs.
Comprehensive Design Expertise: Seamless integration of mechanical, optical, software, and electronics for user-friendly designs.
Custom Optical & Electronics Development: Custom optics and PCBs designed to device specifications.
Software & Firmware Development: Advanced software and firmware that integrate with hardware for enhanced functionality.
Risk Management & Product Verification: Risk assessments and verification to ensure safety, effectiveness, and compliance.
Design Optimization & Testing (DFM, DFA & Prototyping): DFM, DFA principles applied early, with prototyping and iterative testing to refine the product.
Supply Chain Management
Seamlessly manage components and materials with efficient strategies:
Custom solutions for optical, molded, and electronic components.
Strong vendor relationships and global sourcing capabilities.
Real-time inventory management to reduce waste and ensure availability.
Precision Component Manufacturing
Produce high-accuracy components tailored to your needs:
Advanced CNC machining for intricate geometries.
3D printing for rapid prototyping and 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, and more.
Expertise in Software as a Medical Device (SaMD) compliance.
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 to meet regulatory requirements.
Guidance on preclinical, feasibility, and post-market evaluations.
Regulatory Intelligence and Affairs
Simplify complex regulatory processes with expert guidance:
Global certifications, including EU MDR, US FDA, and ISO 13485.
Integration of regulatory requirements during development.
Real-time monitoring of evolving compliance standards.
Software as a Medical Device (SaMD) and Artificial Intelligence
Leverage advanced technologies with comprehensive support:
Usability testing and cybersecurity measures for SaMD.
Clinical validation methods 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.
Medical Product Assembly
Product Verification
We ensure the highest quality standards through rigorous testing and inspection
Comprehensive Quality Control: Every material undergoes strict inspection before production.
Precision Testing: Custom-built components are verified against design specifications.
Regulatory Compliance: Our products meet ISO 13485, FDA, and GHTF standards.
Advanced Reliability Testing: Each device is tested for:
Electrical Safety Vibration & Drop Resistance Transportation Durability
Ageing & Performance Image Quality
Transparent Quality Tracking: Customers can monitor product quality with our CAPA tracking system.
Packaging & Storage
Designed for safety, durability, and compliance
Rugged Packaging: Ensures safe transit and handling of medical devices.
Long-Life Labeling: Resistant to environmental factors for long-term clarity.
Controlled Storage: Finished products are preserved in optimal conditions for maximum reliability.
Procurement & Supply Chain
Optimized for efficiency and faster delivery
Global Supplier Network: Ensuring high-quality materials with reduced lead times.
Custom Component Development: Specialized tooling and electronics tailored for superior performance.
Smart Inventory Management: ERP-driven tracking for real-time visibility and reduced waste.
Strict Supplier Quality Control: Continuous monitoring for consistent excellence.
Seamless Logistics
Fast, reliable, and global delivery
Optimized Supply Chain: Ensuring timely fulfillment with streamlined logistics.
Strong National & International Partnerships: Reliable deliveries, no matter where you are.
Product Verification
Comprehensive Quality Control: Every material undergoes strict inspection before production.
Precision Testing: Custom-built components are verified against design specifications.
Regulatory Compliance: Our products meet ISO 13485, FDA, and GHTF standards.
Advanced Reliability Testing: Each device is tested for:
Electrical Safety Vibration & Drop Resistance Transportation Durability Ageing & Performance Image Quality
Transparent Quality Tracking: Customers can monitor product quality with our CAPA tracking system.
Packaging & Storage
Designed for safety, durability, and compliance
Rugged Packaging: Ensures safe transit and handling of medical devices.
Long-Life Labeling: Resistant to environmental factors for long-term clarity.
Controlled Storage: Finished products are preserved in optimal conditions for maximum reliability.
Procurement & Supply Chain
Optimized for efficiency and faster delivery
Global Supplier Network: Ensuring high-quality materials with reduced lead times.
Custom Component Development: Specialized tooling and electronics tailored for superior performance.
Smart Inventory Management: ERP-driven tracking for real-time visibility and reduced waste.
Strict Supplier Quality Control: Continuous monitoring for consistent excellence.
Seamless Logistics
Fast, reliable, and global delivery
Optimized Supply Chain: Ensuring timely fulfillment with streamlined logistics.
Strong National & International Partnerships: Reliable deliveries, no matter where you are.
Medical Product Assembly
Product Verification
Quality plans control incoming materials and ensure compliance.
First Article Inspection guarantees precision in custom parts.
Comprehensive product testing aligns with PRD standards and includes functional, safety, and reliability tests (e.g., electrical, vibration, transportation, drop, and aging tests).
Process validation adheres to GHTF regulatory standards.
ISO 13485 and FDA-compliant CAPA tracking software supports transparent issue resolution.
Labeling, Packaging, & Storage
Durable labeling and rugged packaging tailored for medical devices.
Controlled storage conditions ensure product quality.
Procurement
Efficient inventory management with global supplier collaborations to reduce lead times.
Expert partners create custom molds, electronics boards, and wiring harnesses.
Continuous supplier evaluation ensures material quality.
Logistics
Robust delivery processes ensure timely shipments via national and international logistics networks.
Precision Component Manufacturing
Advanced CNC Machining
Equipped with state-of-the-art CNC turning, milling, and turn-mill centers for highly accurate, repeatable components.
Precision Engineering
Expertise in machining various materials, including metals (aluminum, stainless steel, titanium) and composites, for unique project requirements.
Multi-Axis Machining
Multi-axis CNC machines allow complex operations, such as contouring, drilling, threading, and profiling, on intricate geometries.
Custom Prototyping & Production
Offers rapid prototyping and scalable high-volume production.
Quality Assurance
Strict quality controls using advanced inspection equipment ensure specifications and high standards are met.
Frequently Asked Questions
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.
