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Meditech

At SFACTO, We help bring and accelerate innovative medical devices from concept to reality with a strong focus on safety, usability, and compliance. Our end-to-end product development expertise spans ideation, design, prototyping, validation, and manufacturing transfer. By integrating engineering excellence with regulatory knowledge, we ensure that every product is not only technologically advanced but also compliant with global healthcare standards (FDA, ISO 13485, MDR)—accelerating time to market while maintaining the highest levels of quality and patient care

Initial Idea to end-of-product life cycle

  • Plan
  • Design
  • Build
  • Maintain
01 Requirement Gathering & Benchmarking
  • Collect clinical, regulatory, and user requirements
  • Benchmark against industry standards and competitive products
  • Develop innovative product concepts with a focus on safety, usability, and patient outcomes
  • Explore multiple design alternatives for risk and feasibility assessment
  • Create detailed CAD models of electromechanical and biomedical components
  • Integrate hardware, embedded systems, and ergonomics in design
  • Perform structural, thermal, and fluid simulations specific to medical devices
  • Virtually validate performance under real-world operating conditions
  • Rapid prototyping using 3D printing, microfabrication, or biomedical-grade materials
  • Evaluate ergonomics, safety, and usability through functional models
  • Incorporate feedback from clinicians, patients, and regulatory experts
  • Optimize design for manufacturability, sterilization, and biocompatibility
  • Assess manufacturability in GMP/ISO 13485-compliant environments
  • Design tools, fixtures, and production processes tailored for medical devices
  • Transfer final design to manufacturing with complete design history file (DHF)
  • Support regulatory approvals and submission packages (FDA, CE, MDR)
  • Post-market surveillance, product updates, and variant development
  • Lifecycle management, remediation, and end-of-life planning

At SFACTO, We deliver cutting-edge Meditech automation solutions designed for precision, reliability, and flexibility in regulated environments. Our modular automation systems integrate seamlessly into existing production lines, delivering scalable solutions tailored to specific product and market needs. With a strong focus on quality, traceability, and regulatory adherence (FDA, ISO 13485, MDR), SFACTO is your trusted MedTech engineering service provider partner for next-generation healthcare manufacturing

Initial Idea to end-of-product life cycle

  • Plan
  • Design
  • Build
  • Maintain
01 Requirement Analysis & Process Definition
  • Gather automation requirements based on product type, volume, and regulatory needs
  • Map critical processes (assembly, inspection, testing, packaging)
  • Develop automation concepts and high-level system design
  • Define modular, scalable solutions for future upgrades
  • Design tools, fixtures, jigs, and handling systems for medical components
  • Perform kinematic simulations and ergonomic studies
  • Connect & Simulate – Link PLC/control to virtual environment; test logic, safety, sequencing.
  • Validate & Optimize – Resolve flaws, improve workflows, ensure compliance.
  • Develop control architectures using PLCs, microcontrollers, or FPGA platforms
  • Ensure redundancy, safety, and compliance with IEC/FDA guidelines
  • Real-time control software, HMI, and data logging systems
  • Integration with MES/ERP for traceability and compliance
  • Build functional prototypes for critical subsystems
  • Test pilot automation lines in controlled environments
  • IQ/OQ/PQ validation of automation systems
  • Documentation to support FDA, ISO 13485, and GMP compliance
  • Deploy automation lines into full-scale manufacturing
  • Seamless integration with existing production infrastructure
  • Implement predictive maintenance, OEE tracking, and data analytics
  • Continuous improvement for throughput, reliability, and cost efficiency
  • Comprehensive training for operators and maintenance teams
  • On-site and remote technical assistance for troubleshooting and upgrades
  • Spare parts management, service contracts, and lifecycle support

At SFACTO, We provide AI-driven simulation solutions tailored to the medical technology industry. Our expertise includes building digital twins of medical devices and healthcare processes, integrating sensor data for real-time monitoring and predictive analytics.Powered by NVIDIA Isaac Sim, our simulation platform enables the virtual development and testing of medical robots—helping reduce costs, shorten development cycles, minimize risks, and accelerate innovation

Initial Idea to end-of-product life cycle

  • Plan
  • Design
  • Build
  • Maintain
01 Requirement Definition & Use-Case Mapping
  • Define simulation objectives (device performance, surgical workflow, robotics, patient safety)
  • Map clinical, mechanical, and regulatory requirements into simulation scope
  • Build high-fidelity CAD and physics-based models of medical devices or processes
  • Incorporate material properties, fluid dynamics, and biological interactions
  • Create digital replicas of devices, production lines, or healthcare workflows
  • Integrate real-world sensor and IoT data for continuous updates
  • Run multi-physics simulations (structural, thermal, fluid, fatigue, biocompatibility)
  • Validate models with experimental and clinical test data
  • Apply AI algorithms for predictive analytics and performance optimization
  • Train models for anomaly detection, risk analysis, and failure prediction
  • Simulate robotic-assisted surgical procedures using platforms like NVIDIA Isaac Sim
  • Evaluate precision, ergonomics, and safety in virtual environments
  • Test multiple design iterations virtually before physical prototyping
  • Run what-if scenarios for stress, wear, sterilization, and usability
  • Generate simulation reports aligned with FDA/MDR digital evidence requirements
  • Support documentation for regulatory submissions and approvals
  • Integrate simulation insights into R&D, manufacturing, and clinical workflows
  • Continuous refinement of digital twins for lifecycle management and post-market support

Why Choose Us For Your Business

Choose SFACTO for a partnership where innovation meets customization

Indudial Consulting

Our highly qualified experts collaborate with customers throughout the production lifecycle, providing professional, technical, and cost-efficient solutions alongside tailored resolutions.

Design & Simulation

The design and simulation of automation processes and equipment are conducted in close collaboration with our customers. This approach enables us to effectively address individual requirements and ensure maximum system availability throughout the production phase

Installation & Commissiong

From the manufacturing of equipment and its safe shipment, through pre-assembly and commissioning at our facilities, to onsite installation and final prove-outs. We meticulously manage every phase to ensure seamless progress, quality, and efficiency at every step

After Sales Solutions

Our comprehensive aftermarket solutions featuring digital monitoring, system upgrades, performance optimization, and rapid technical support, ensure long-term reliability, and sustained operational excellence beyond project handover.

On-time delivery, every time

We value punctuality and reliability, ensuring every project is delivered on time—without delays or excuses

Budget-conscious, value-focused

Respecting your budget, staying transparent, and open to negotiation at every stage— to find the right fit together.

Deliverables that exceed expectations

We go the extra mile to deliver beyond expectations and We believe our customers’ success is our success.

Try Us, Leverage Our Expertise,
Create Value, Succeed Together

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Contact Us

  • connect@sfacto.com
  • +91 406149630
  • +91 9705288676
  • GS Dasaradha Orchid, Hyderabad, INDIA - 500018

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