Medical Devices Regulatory Compliance services
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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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2024 HIPAA Compliance Training Guide to the Compliance Officers
Can coffee help me lose weight? Yes, 25,422 users in the USA use it for that ...
Can coffee help me lose weight? Yes, 25,422 users in the USA use it for that ...
Innovative Minds France's Most Impactful Healthcare Leaders.pdf
Innovative Minds France's Most Impactful Healthcare Leaders.pdf
Psychedelic Retreat Portugal - Escape to Lighthouse Retreats for an unforgett...
Psychedelic Retreat Portugal - Escape to Lighthouse Retreats for an unforgett...
Common Challenges in Dermatology Billing and How to Overcome.pptx
Common Challenges in Dermatology Billing and How to Overcome.pptx
Champions of Health Spotlight On Leaders Shaping Germany's Healthcare.pdf
Champions of Health Spotlight On Leaders Shaping Germany's Healthcare.pdf
Comprehensive Rainy Season Advisory: Safety and Preparedness Tips.pdf
Comprehensive Rainy Season Advisory: Safety and Preparedness Tips.pdf
Medical Devices Regulatory Compliance services
- 1. Medical Electronics Practice Regulatory Compliance Services
- 2. 2 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
- 3. 3 Thank You