Case Study

Highlights

• 250+ Engineers working across 4 business units.
• Presence across Product Development, Software Engineering, Manufacturing, QE, Post Market Surveillance and Regulatory Affairs.
• Technologies : Azure, AWS, Salesforce, Dynamics CRM, Java, ReactJS, NodeJS, .NET, CAD, CAM, FDA 21 CFR Part 820 and ISO 13485 standards.
• Delivered Strategic Projects :
  • Project Gurney – Covid test kits designed and developed in record time while meeting all the FDA requirements.
  • QA Integration – Merged the quality systems of St. Jude Medical after acquisition.
  • FDA & MDR/IVDR Compliance for several implantable devices and diagnostic equipment.
• Engineering & Talent Management Services to a Fortune 100 medical devices and health care company.