Case Study :
Engineering & Talent Management Services to a Fortune 100 medical devices and health care company.
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.