CLEPIER LIMITED provides Training, Audit & Certification services in co-operation with different International Accreditations / Partners for: 

Indian Registration/ Compliance: 
•       Indian MDR 2017 (Medical Device Regulation)
•       Indian Notified Body Approval 
•       Free Sale 
•       GMP  

EU Product Approvals & Related Services: CE Marking: 
•       Medical Device Directive 93/42/EEC   
•       Medical Devices Regulation (EU) 2017/745 & In-vitro Diagnostic Devices Regulation (EU) 2017/746 
•       EU Representative Selection and Agreement 

US FDA Approvals: 
•	US FDA Registration
•	510K Approvals 
•	21 CFR 820 Documentation and Implementation 

Management System: 
•       ISO 9001:2015, ISO 14001:2015, ISO 45001:2018, ISO 13485:2016, ISO 22000:2018, ISO 27001:2013
•       21 CFR 820 with ISO 13485:2016 Medical Devices – Quality Management Systems 

Food Certification

•	GMP, HACCP, FAMI – QS, BRC,  AGMARK, GLOBAL GAP, Organic Certificate

Clepier Limited

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