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Dear All, Thanks !! for going across TATA Elxsi Medical Device service offerings deck. TATA ELXSI service offerings include: Concept generation/ Idealization Product development Verification & validation Sustenance engineering Cost Reduction Size Reduction Value Engineering Regulatory Compliance If you have any curiosity to know more about our services , Please let me know on below communicable details: Mobile: +91-7387192909 Mail: harsha@tataelxsi.co.in Regards, Harshwardhan
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Medical Electronics Practice
Regulatory Compliance Services
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21CFR Part 820, ISO 13485, CE & EU Directives Compliance
Regulatory guideline compliance – Assessment & GAP analysis
Documentation support for 510 (K) / Pre-market approval
Process, Tools Validation and Post market surveillance support
Testing- EMC/LVD/Biocompatibility (ISO 10993) & compilation of clinical data
Guidance support - Correct labeling / Instruction manual / SOP
Design & development- Risk based approach for validation (ISO 14971)
Maintaining & updating design dossier for higher risk classified devices
Maintaining of DHF/DMR- (Identification & Traceability)
CAPA support
RoHS / REACH compliance
Regulatory Compliance Support & Services
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Thank You
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