Aravindan Chandrasekar
Technical Lead @ HCLTech │Medical Devices | Polarion │ Labeling │ Design Control | DHF Remediation | US FDA 21 CFR 820 | ISO 13485 | ISO 15223-1 | ISO 14971
- Role
- Technical Lead at HCLTech
- Location
- Madurai, TN, IN
- LinkedIn followers
- 500 followers
Experience
Technical Lead
Jun 2018 — Present · Madurai, IN
Established and managed repositories for Standards, Test Methods, and MSA in Polarion.• Developed and maintained universal requirements and clause requirements repositories in Polarion.• Migrated FSRS report data into Polarion as individual work items for traceability.• Created design input documents and facilitated release in SAP.• Designed and updated product labels and IFUs, ensuring regulatory compliance.• Conducted gap assessments against MDR, IVDR, and ISO 15223-1 requirements.• Collaborated with cross-functional teams to analyze requirements, address issues, and deliver
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