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Clepier Limited
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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