Medical device industry has been facing several challenges that include country specific regulatory standards, stringent quality norms, collaborative manufacturing requirements, complex supply-chain systems, cost pressures and increased competitiveness. Neilsoft has developed capabilities to address these challenges and provide comprehensive services to its clients from the medical device domain. Our engineering leadership team includes professionals with several decades of experience in the medical domain, product engineering and advanced manufacturing technologies.

With a focus on Class II and Class III medical devices, our expertise, infrastructure, vendor eco system and industrial alliances, help us in providing integrated solutions that include design, engineering and prototype manufacturing of medical devices. Our process oriented delivery and quality systems are based on regulatory (ISO 13485, FDA 21 CFR Part 820 Quality System Regulation and MDR) and risk management (ISO 14971) requirements.

We have expertise and specialized knowledge to handle various aspects of Medical Device Development including: due diligence, ideation, concept selection, requirements identification / generation, design evaluation & optimization, generating design output elements for verification / risk management and documentation for regulatory submissions in line with ASME V&V 40 guidance document.

Neilsoft Medical Devices Engineering Services:

  • Medical Devices Systems Integration and Development: Systematically covering all aspects of Product Engineering including:
    • Product Development and Component Design
    • Reliability Engineering and Durability support
    • Electromechanical Integration
    • Embedded Interfaces
    • Connected Product Enablement
    • IoT
    • Re-engineering
    • Value Engineering
    • Advanced CAE Analysis
    • Independent Verification and Validation
  • Software Product Development for Medical Applications
    • Orthodontics Applications
    • Orthopaedic Applications
    • Medical Imaging : Segmentation and Reconstruction, Analysis of DICOM Files, Cardiogram Analysis and Diagnostics Services
  • Medical Data Management
    • Cloud Storage of Medical Records
    • PACS Support
    • Data Migration
  • Advanced Visualization – Rendering, Animations, AR and VR
    • AR/VR Applications for Medical Devices, Scientific Process and Surgical Simulation
    • Video Production for Promotion, Training and Treatment Procedure
    • Technical Documentation with 3D animation for Manufacturing Process
  • Medical Equipment Design & Manufacturing Support to support Automation
  • Industrial Automation in Medical Areas
  • FDA and MDR Compliance Services
  • Bio-Design & Solutions Development: Innovation Space & Clean Room Facilities along with 3D Printing and Rapid Prototyping

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