Medical Devices & Diagnostics

Medical Devices & Diagnostics has been growing at a rapid pace and witnessing transformational change to cater to the evolving market dynamics. The device manufacturers are shifting from mere product delivery to a holistic delivery by integrating the products with data intelligence and service. The global nature of the industry and focus on the health of individuals has called for regulatory measures and technological advances in this field.

We at CADVision have been working with Medical devices companies and help them in New Product Development and sustenance with digitalization. Being a ISO 13485 certified design and development services company, our services comply with stringent compliance requirements

Challenges of Medical Devices and Diagnostics Industry (MDDI)

The medical device market is fast becoming a powerhouse in the global healthcare sector. The following are the general challenges that the MDDI  faces :

  • Innovate products to be able to meet the demands of patients and healthcare professionals
  • Embrace the newer technologies to provide consumers with the experience they deserve with evidence-based care
  • Localization of the solutions and products 
  • Compliance with evolving regulatory and security norms
  • Leverage global resources for manufacturing

The industry will look at the following as focus area to combat the challenges:

MDDI focus areas Area of interest 
Product Innovation 
  • New Product Development 
  • Sustenance engineering 
  • Localization/customization of products 
Technological Innovation 
  • Connected Devices 
  • Evidence based care 
  • Patient centric care  
  • Consulting 
  • PLM services 
  • Packaging 
  • Transportation  
Compliance & Regulatory  
  • Regulatory compliance for Class I, II & III products 
  • 510k compliance for product launch 

CADVision offering to MDDI


  Product  Engineering ManufacturingCompliance After Sale
  • Image Processing
  • Product Design software
  • Planning Software for health care professionals
  • Customization
  • Data management
  • PLM implementation
  • Integration with enterprise software
  • Supply Chain integration
  • QMS
  • Compliance management
  • Process automation
  • Performance Analysis
Engineering Services
  • New Product Development
  • Concept to detailed design
  • Design Validation
  • Sustenance engineering
  • Value engineering
  • Manufacturing process development
  • Tools design & development
  • 3D Printing support
  • Packaging support
  • Technical Documentation
  • Verification and validation to FDA/EU to regulations
  • Labelling management
  • Inspection and audit readiness, for ISO 13485
  • Value Engineering
  • Product Maintenance

Our Product Innovation

With our proven track record of developing software solutions to our global customers in Medical Devices Industry, we are well placed to offer

  • Medical software development that involves medical image processing (from the scanned data) and designing custom implants for each patient. Later the implants are manufactured with medical 3d printing.
  • Custom software is used to control product launches in various local markets or geographies while complying with local regulations.
  • Design and development of the required products.
  • Conceptual design and Detailed Design (Mechanical, Electro-Mechanical, and Software).
  • New Product Development focuses on innovation and regulatory alignment from concept to design, development, and post-product launch.
  • Product Sustenance services add new features and address component/technology obsolescence for existing and end-of-life cycle products.
  • Value Engineering aims to enhance product features, build interoperability, improve quality, and reduce cost

Keeping up with Technology

By embracing new technology and keeping abreast of technological advancement, we have become a strategic partner to some of our clients across different industries. The following are some of our technological developments helping us provide high-value offerings to MDDI.

  • Image processing  
  • Mesh Generation 
  • Segmentation 
  • AI/ML based suggestive approach for patient monitoring 
  • Mobile application development  
  • Process automation for processes covering design till delivery 
  • Open CV, ITK, VTK, QT 
  • Good exposure in Scan to 3D 
  • Expertise in all leading MCAD applications automation. 
  • Verification & Validation 
  • Class I to Class III device software development 
  • User interface design & development 
  • Stand alone, cloud and web application development  
  • Auditing, logging, and reporting  
  • Tabular, graphical on screen and PDF report creation 
  • Formal execution and creation of verification reports. 
  • Test strategy design and test protocol development. 


  • PLM, PDM  implantation and consulting 
  • Packaging, Labelling like QR and Bar codes 
  • Medical 3D printing support : generate 3D printable parts from design 

Compilance & Regulatory:

  • Support Compliance management 
  • Technical Documentation 
  • Verification and validation to FDA/EU to regulations 
  • Labelling management 

Realize Business Impact with CADVision:

These are the typical business benefits for clients who are availing of outsourcing services from CADVision:

  • Flexible staffing with quick ram-ups for urgent needs. 
  • Cost reduction in the range of 30 to 40% 
  • Year on Year Product improvement by 5 to 10% 
  • Improved time to market