Clepier Limited

CLEPIER LIMITED provides Training, Audit & Certification services in co-operation with different International Accreditations / Partners for: Training, Audit & Certification for: ISO 9001:2015 Quality Management Systems ISO 13485:2016 Medical Devices Quality Management Systems ISO 14001:2015 Environmental management systems ISO 45001:2018 Occupational health and safety management systems ISO 22000:2018 Food safety management systems ISO/IEC 27001:2013 Information technology A Security techniques A Information security management systems General Awareness Programme on CE Marking - Medical Device Directive (93/42/EC), In Vitro Diagnostic Device (98/79/EC), Low Voltage Directive (2014/35/EU), Electro Magnetic compatibility (2014/30/EU), Machinery Directive (2006/42/EC), ATEX 2014/34/EU, PED 2014/68/EU, RoHS, CPR (EU) No 305/2011 General Awareness Program on EU Regulations Medical Devices Regulation (EU) 2017/745 & In vitro Diagnostic Devices Regulation (EU) 2017/746 Detailed Programme on Essential Safety Requirements (ESR), Risk Assessment (RA), EC Declaration of Conformity (EC DOC), LABEL AND IFU - Medical Device Directive (93/42/EC), In Vitro Diagnostic Device (98/79/EC), Low Voltage Directive (2014/35/EU), Electro Magnetic compatibility (2014/30/EU), Machinery Directive (2006/42/EC), Training on Clinical Evaluation / Performance of Medical Devices MDD 93/42/EC / InVitro Diagnostic Devices (IVDD 98/79/EC) Other Certifications with Associates/ Guidance regarding the same: EU Product Approvals: CE Marking, RoHS, PED, ATEX