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About Us
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Quality Management Certifications
ISO 9001:2015 Certification
ISO 13485:2016 Certification
ISO 14001:2015 Certification
ISO 45001:2018 Certification
ISO 27001 Certification
ISO 22000:2018 Certification
HACCP Certification
AS/EN 9100 and Other
Product Certification
MEDICAL DEVICE DIRECTIVE (MDD 93/42/EEC - 2007/42/EC)
MACHINERY DIRECTIVE (MD) 2006/42/EC
PRESSURE EQUIPMENT DIRECTIVE 2014/68/EU
LOW VOLTAGE DIRECTIVE (LVD) 2006/95/EC
CONSTRUCTION MATERIALS 89/106/EC, 93/68/EEC
ELECTROMAGNETIC COMPATIBILITY DIRECTIVE (EMC) 2004/108/EC
Other as per requirements
Trainings
ISO 9001:2015 Certification Training
ISO 13485:2016 Certification Training
ISO 14001:2015 Certification Training
ISO 45001:2018 Certification Training
ISO 27001 Certification Training
ISO 22000:2018 Certification Training
Guidance on Clean Room Validation
Guidance on USFDA, WHO & GMP
Risk Analysis as per EN ISO 14971:2012
Other Services
RoHS (Restriction On Hazardous Substance) Certification
FDA Laisoning / USFDA
510K Approval
Drug Dossier Preparation
GMP Implementation & Monitoring
Process Validation
MHRA Registration
Free Sale Certification (From Europe)
European Authorized Representative (EAR)
Testing
Biocompatibility Testing
Electrical Safety Testing (From NABL Accredited Lab)
EMI / EMC Testing (From NABL Accredited Lab)
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