CONSULTATION & CERTIFICATIONS

Management System: ISO 9001, ISO 14001, ISO 13485, OHSAS 18001, ISO 20000, ISO 22000, ISO 27001, ISO 50001, ISO/TS 16959, ISO 20252
& Pharmaceutical GMP/GMP/WHO GMP/ Schedule M, EXCiPACT, Business Development

Product Certification: 93/42/EC-Medical Device
98/79/EC-In Vitro Diagnostic Medical Devices
2006/42/EC-Machinery Directive
97/23/EC-Pressure Equipment Directive
2014/35/EU-Low Voltage Directive
2014/30/EU- Electro Magnetic Compatibility Directive
2014/34/EU- Equipment and protective systems intended for use in potentially explosive atmospheres

Russian Approvals: Gost R i.e. TR CU (EAC Declaration & EAC Certificate)

US FDA Approvals: US FDA Registration
510K Approvals, FDA 21 CFR 211 (cGMP) - Implementation & Post Inspection Support

Indian Registration: ICMED 9001, 13485
BIS Certification/Registration

Food Certifications: FSSAI, HACCP, HALAL, BRC

TRAININGS

We provide consultancy and training services for various ISO certifications such as;

ISO 9001 - Quality Management System, ISO 14001 - Environment Management System, ISO 13485 - Medical Device Quality Management System, BS OHSAS 18001 - Occupational Health and Safety Management, ISO 20000 - IT Service Management, ISO 22000 - Food Safety Management System, ISO 27001 - Information Security Management System, ISO 50001 - Energy Management System, ISO/TS 16959, ISO 20252 - Market Opinion & Social Research.

Custom based trainings: CE Marking, Gost-R, Clinical Evaluation, Risk Assessment.

Consultancy services are aimed to achieve intended benefits of relevant ISO standard which is implemented in the organization.

VALIDATIONS & TESTING’S

We provide special process validation services, organization requiring help in sterilization, validation such as

• > Ethylene Oxide(EO)
• > Gamma(Irradiation)
• > Steam(Autoclave)
• > Clean Room validations
• > Equipment Qualifications

TESTING’S

We can help manufacturers in getting all kind of Electrical, Mechanical, Microbiological, Food & Biocompatibility testing through our various partners who are NABL/17025 accredited laboratories