Device Engineering

Engineering Greater Value for Global Medical Device Companies

Digital Services

Overview

With a combination of Agile methodologies, well-defined SOPs and quality control checks, Syntel helps improve quality and reduce TCO across the end-to-end device engineering lifecycle for multiple therapeutic areas. We support R&D engineering, new product development, sustenance engineering, reliability engineering, and end-of-life support.

Our Engineering team has hand-on experience with the leading CAD, CAM, CAE and PLM tools on the market, and we deliver high value at low cost by supporting clients with an extended offshore team that adheres to your processes and Quality Management System.

Offerings

Concept & Idea Generation

  • Market research and benchmarking
  • Requirement gathering and VOC generation
  • Prototype development/ Proof-of-Concept

Design & Development

  • 3D parametric modeling and 2D detailing
  • Detail design for metal, plastics and sheet metal
  • Gage, jig & fixture design, tool and mold design
  • Design for manufacturing/ reliability/ serviceability 

Verification, Validation and Reliability

  • Test protocol development and validation
  • Simulation and CAE analysis
  • Process, device, equipment and software (CSV) validation
  • Mechanical, environmental, functional prototypes and packaging testing

Lifecycle Support

  • Sustenance engineering
  • Risk assessment
  • Configuration management, CAD/PLM customization and management

End-of-Life Support

  • Re-engineering
  • Legacy drawing conversion
  • Obsolescence management

Quality Assurance & Regulatory Affairs Support

  • QMS implementation, CAPA support
  • Design controls, Tech File, DMR, DHF
  • Audit support, supplier quality audit
  • Change management
  • 510k and PMA submissions
  • Product lifecycle management
  • Records and Document Management

The Syntel Advantage

  • G-Agile Framework: Automation-driven Agile project management tools and methodologies to improve speed and First-Time-Right
  • Diverse Therapeutic Experience: Includes engagements in surgical, cardiovascular, orthopedics, ophthalmology, endocrinology, gastroenterology, nephrology and oncology
  • Deep Expertise in product analysis, product engineering, local market analysis and product reengineering
  • Cross-Functional Capabilities: Experience in QA, regulatory affairs, labeling, packaging, technical documentation and records management
  • Strong Partnerships: Supporting the end-to-end engineering value chain with a network of manufacturing service providers and healthcare facilities
  • Investments in Innovation: Committed to continuously invest in competencies, IP and infrastructure to create innovative solutions for our clients
  • Robust, multi-geography framework for regulatory compliance
  • Support for FDA unique device identification requirements, including audit trails and electronic signatures for individual complaints
  • Specialized team and laboratory infrastructure support for designing prototypes, running simulations, analyzing results, and validating design
  • Customized solution development to meet your unique needs by collaborating with stakeholders from design, development, verification and validation
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