BIS 23485 consultant

BIS carries out new IS standard for Medical Devices Implementing new BIS 23485 guidelines are relied upon to make Organizations more agreeable with the fundamental standards of Safety and Performance/Quality Management System prerequisites .The Bureau of Indian Standards (“BIS”) has distributed another standard BIS 23485 Medical Devices – Quality Management System necessities and Essential Principles of wellbeing and execution for Medical Devices.

Implementation of this standard by an association would incorporate consistence to “fundamental standards of safety and execution just as to QMS requirements; which incorporate risk evaluation and the executives for the planning and manufacturing of medical devices, clinical evaluation, bio compatibility confirmation, ecological impacts’ evaluation, programming approval and other security and execution related viewpoints prone to be experienced during whole life pattern of a medical device.

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Contact details –

Phone  no -  93702 83428

Mail id – enquiry@operonstrategist.com

If  You Want Medical Devices Services Consultation For Following.

1. Medical Device Consulting 
2. cdsco registration 
3. FDA 510k Clearance 
4. ce mark medical device 
5. CDSCO Manufacturing License 
6. CDSCO import license 
7. TURNKEY PROJECT CONSULTANT 
8. medical device manufacturing 
9. iso 15378 certification 
10. 21 cfr part 210 and 211 
11. ISO 13485 Medical Device Consultant 
12. Primary Packaging Turnkey Project Consultant 
13. Clean Room Design Consultant 
14. manufacturing site conceptualization 
15. Market Analysis and feasibility for Medical Devices 
16. manufacturing plant layout design 
17. medical device design and development 
18. DMF file submission guideline 
19. 21 cfr part 820 
20. qms certification services 
21. capa management 
22. design control requirements 
23. medical device process validation 
24. combination product 
25. continuous improvement program 
26. Medical Device Compliance & Regulatory Services 
27. Cdsco India authorized agent for medical device