Services for the Medical Devices industry

Services for the Medical Devices industry

Today, increased regulatory scrutiny, disruptive technologies, healthcare reforms and economic uncertainty are driving changes in the industry – from focused interactions to 24×7 self- and remote-monitored personalized models.

At QuEST Global, we leverage our engineering acumen to help medical device leaders to design cutting-edge solutions that not only meet emerging customer expectations and trends, but also comply with stringent regulatory requirements.

From the first stage of development, production support, post-product introduction support, verification and validation, our superior expertise and experience, ensure your products meet today’s stringent safety, design and regulatory requirements.

Our services and solutions in equipment, medical device software development, interoperability and electronics help medical device manufacturers to:

  • Shorten regulatory approval timelines
  • Reduce time-to-market
  • Streamline aftermarket product quality support

Services offered

We offer services throughout the entire medical devices product lifecycle:

Engineering software

Embedded and electronic systems

Design and development

  • Proof of concepts and feasibility studies
  • Application frameworks
  • Platform design
  • UX design and prototyping
  • Algorithm modeling and implementation
  • Enterprise application integration
  • Regulatory and industry standard compliance

Design and development

  • Embedded applications and UI development
  • Communication protocols
  • Interoperability interfaces
  • Firmware
  • GPOS / RTOS
  • BSP
  • VLSI and FPGA
  • Schematic design
  • PCB design

Production support

  • Configuration management
  • Build management
  • Continuous integration
  • Technical documentation
  • Compliance certification
    • FDA premarket submission
    • 21 CFR 820
    • ISO 13485,14971

Production support

  • Technical documentation
  • Configuration management
  • Compliance certification
    • Remediation support
    • RoHS compliance FDA Premarket submission
    • CE Marking
    • 21 CFR 820
    • ISO 13485,14971
    • IEC 62304, 62366, 60601

Post product introduction support

  • Reengineering and modernization
  • Value engineering
  • Localization and internationalization
  • Application performance engineering
  • Maintenance of multiple product lines
  • Service pack and hot fix support
  • Product customization

Post product introduction support

  • Reengineering and modernization
  • Value engineering
  • Maintenance of multiple product lines
  • Service pack and hot fix support
  • Obsolescence management
  • Product customization

Verification and validation

  • Functional testing
    • Performance testing
    • Load and stress testing
    • Compliance testing
    • Unit, integration and system testing
    • Test automation

Verification and validation

  • Functional and non-functional testing
  • Compliance testing
  • Unit, integration and system testing
  • ATE development
  • Test fixtures and test jigs
  • Reliability testing
  • Environmental stress test
  • HASS/HALT

Proven Track Record

At QuEST, we have not just the expertise, but also a proven track record, of helping our global clientele.

  • We spearheaded the largest offshore development center (ODC) outside Japan for a Japanese medical OEM
  • We engineered the entire software stack for the world’s first portable CT scanner
  • We executed medical device software development projects for more than 25 diagnostic imaging product lines

How QuEST Global helps

As a leader in mechatronics, engineering, software development for embedded systems, we help you in a number of ways: 

  • Our expertise – in delivering solutions that help in safer, faster and accurate diagnostics
  • Our experience – in building and scaling global customer-dedicated centers
  • Our flexibility – in operating diverse business models – local, local–global and global
  • Our ability to fast-track development – in supporting faster product releases for improved market share
  • End-to-end ability – in offering support across medical devices as well as medical device software development lifecycles
  • Readiness – in meeting stringent regulatory requirements, adhering to diverse global regulatory standards

QuEST Global is a focused global engineering solutions provider with a proven track record of 18 years serving the product development & production engineering needs of high technology companies. A pioneer in global engineering services, QuEST is a trusted, strategic and long term partner for many Fortune 500 companies in the Aero Engines, Aerospace & Defense, Transportation, Oil & Gas, Power, Medical Devices and other high tech industries. The company offers mechanical, electrical, electronics, embedded, engineering software, engineering analytics, manufacturing engineering and supply chain transformative solutions across the complete engineering lifecycle.

QuEST partners with customers to continuously create value through customer-centric culture, continuous improvement mind-set, as well as domain specific engineering capability. Through its local-global model, QuEST provides maximum value engineering interactions locally, along with high quality deliveries at optimal cost from global locations. The company comprises of more than 7,500 passionate engineers operating out of nine different countries intent on making a positive impact to the business of world-class customers, transforming the way they do engineering.