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Medical Devices

Overview

Globally Medical Devices Industry has been going through rapid transformation in the last decade and seen many challenges including dynamic regulatory environment, unmet needs of emerging markets and demand for faster product development. There has been increased penetration of new technologies like IoT, Additive Manufacturing and Big Data Analytics to meet some of these challenges.

AXISCADES offers product engineering services for the Medical device industry in the areas of mechanical, embedded electronics, technical publication, and remediation. We have extensive experience in the medical segments like Orthopedic, Hospital & Laboratory equipment and Patient monitoring devices. We have worked on various Class I and II Medical Devices for developed and emerging market.

As an ISO 13485 certified company, we have partnered with our customers to improve safety and reliability, lower the engineering costs, apply tailor made processes and methodologies thus minimizing the risk and maximizing the quality of the product.


Medical Segment Experience:

    Orthopedic:
  • Hips, Knees
  • Foot & Ankle
  • Spine
         
    Hospital Equipment:
  • Patient Monitoring Systems
  • Laboratory Equipment’s
  • Diagnostic Equipment’s & Imaging

Medical Device Service Offerings:

We provide services for complete product development life cycle of medical devices – Orthopedic and Hospital equipment. We help our customers to develop new products and has strong domain expertise in mechanical design and regulatory compliance adhering to ISO 13485, ISO 14971 and IEC 62304.

    Product Design & Engineering:
  • Voice of Customer – User and Market Requirements
  • Conceptualization
  • Design & Detailing and Documentation
  • Engineering Analysis – Static, Dynamic, Thermal and CFD
  • Packaging – Plastics, Sheet metal
  • DFM/ FMEA Studies
  • Design Automation


Quality and Regulatory Affairs:
  • Design Control – DHF / Technical File
  • Remediation – Translation / Documentation
  • Medical Quality Management Services (MQMS) – Audits, Process definition, implementation, trainings
  • Risk Analysis/ Management - RMF
  • CAPA Implementation
  • RoHS Compliance
  • Labeling – IFU


Medical Electronics:
  • System Engineering
  • Embedded Software and Hardware Engineering
  • Testing and Verification & Validation
  • Firmware Development
  • Connectivity and Data Aggregation
  • Device Mobility / App Development
  • Wireless Technologies


Manufacturing Support:
  • Digital Manufacturing
  • Prototype Development
  • IQ/OQ/PQ Validation
  • Should Costing
  • Vendor Evaluation & Selection
  • Tool Design
  • Jigs & Fixture Design


After Market Services:
  • Post Market Surveillance
  • Cost Take Out / Value Engineering
  • Sustenance Engineering
  • Localization
  • Reliability & Life Extension
  • Obsolescence Management
  • Technical Documentation


Why partner with AXISCADES?

  • 8+ years of experience in Medical Device Engineering Services and worked closely with our customers to meet their business goals
  • Partnered with one of top 5 orthopedic 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

Customer Testimonial

AXISCADES enables us to meet our tight schedules by providing the most satisfactory solutions in the Automotive Product Design and Engineering Services. We are definitely going to work with them on our future Automotive Programs.


Manager-Design, Automotive Systems Manufacturer

Medical Devices Case Studies

  • Design and Development of an automated B P Monitor for hospital use
  • Implementation of the Unique Device Identification on a Knee replacement system for US market
  • Remediation of Orthopedic Instrumentation
  • Design of the access system for reconstructive device