Engineering Safe Reliable and Connected Medical Devices

  • Integrated solutions offering across engineering, manufacturing and supply chain
  • Efficient delivery process and quality procedures for regulatory and safety compliance
  • Strong program management practices and capability in terms of technology and scalability
  • Flexible engagement and cost models for offshore and onsite development
  • Reliable eco system for sourcing, prototyping and manufacturing

Medical Devices Product Segment Experience

Infusion & Drug Delivery systems
Diabetes care & Insulin Delivery
Surgical Systems
Orthopaedics: Spine, Hip, Knee & Shoulder
Hospital Equipment & ICU beds
Cardiovascular & Endovascular
Electro – Mechanical & Sterile packaging
Power Tools
Patient Monitoring

Product Design & Engineering

New Product Development Product Concept/ Feasibility/ Spec Design & Development, Design Verification & Validation, Design Review, Design Transfer
Sustenance & Post Market Defect Management, Value Engineering, Localization, Shelf Life Studies, ISO Testing, Legacy Conversion, Obsolesence Management, ECM, PMS
Remediation DHF & RMF, Translation Services, CAPA Initiatives, UDI, Acquisition Remediation, FDA483, Technical Publications
Regulatory 21 CFR, IEC 62304, IEC – 60601 & particular standards
Standards ISO 13485, ISO 14971, IEC 60601, IEC 62304

Mechanical Engineering Capabilities

Design DFM, DFx, Industrial Design, 3D & Analytical Modelling, Design Automation
FEA Linear & Nonlinear, Dynamic Analysis, Thermal & CFD: Thermo-Mechanical Analysis, Cumulative Damage Analysis, Snap Fit Analysis
Reliability & Analysis Reliability Allocation & Prediction, Hazard Analysis, FTA, FMEA/ FMECA
Manufacturing Engineering Digital Manufacturing, PCM Layout, Tool Design – Plastics, Sheet Metal, Casting, Manufacturing Eco System, Should Costing

Embedded & Electronics Capabilities

Software Development Software Design, S/W & H/W Integration, Device Mobility/ App Development
Hardware & Firmware Development Low level drivers, Boot loader, RTOS, System Integration, Model Based Development
V&V and Testing Functional, Unit and Integration Testing, Test Script and Protocol, EMI/ EMC Testing, Black Box/ White Box
Programming C, C++, Matlab, AVA, Python, .Net, Labview
Protocols SPI, CAN, UART, RS232, I2C
OS QNX, LINUX, Windows, iOS, Android
Connectivity Bluetooth, BLE, WiFi, Zigbee, RF
DSP Image Processing, Audio Processing, ECG, EEG

Why AXISCADES

Values that we bring
  • Readiness to invest based on ROI
  • Risk reward sharing partner
  • Rapid resource augmentation
  • On time regulatory compliance
  • Rapid Adoption to new tech
  • Lower development cost
  • Faster time to market
Key Highlights
  • 8+ years of experience in Medical Device Engineering Services
  • Partnered with one of the Top 5 orthopaedic customers to implement UDI faster
  • Strong expertise in Mechanical Design, Embedded Electronics and Value Engineering
  • Strong understanding of FDA 510(k), ISO 13485, ISO 14971 processes
  • Dedicated PMO office to manage cross functional projects

Additional Reading and Resources

Digitization

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Shop Floor Automation

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Smart Process Automation

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Manufacturing Intelligence

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IOT

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Augmented and Virtual

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Embedded Solutions

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Mechanical Engineering

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PLM

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MES

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Additive manufacturing

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AI/ML

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Technical Publication

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Additional Reading and Resources

Digitization

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Shop Floor Automation

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Smart Process Automation

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Manufacturing Intelligence

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