Our Services

Consultation & Certifications:

  • Management System:
    ISO 9001, AS 9001, ICMED 9001, ISO 13485, ICMED 13485, ICMED 13485 Plus, ISO 14001, ISO 18001, SO 20000, ISO 22000, ISO 27000, TS 16494
  • Product Certification:
    CE marking, 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 Directive, 95/16/EU – Lift Directive, 2011/65/EC – RoHS Directive
  • Russian Approvals:
    TR CU (EAC Declaration & EAC Certificate)

‚ÄčTrainings:

  • Awareness Trainings on System Certification
  • Awareness Trainings on Product Certification
  • Internal Auditor Trainings
  • Lead Auditor Trainings
  • Specialized Trainings (Customized Program)

Validations:

  • EO Sterilization Validation
  • Gamma Sterilization Validation
  • Steam Sterilization Validation
  • Process Validations

Testing’s:

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  • Medical Devices testing
  • Machinery testing
  • LVD & EMC testing
  • Food Safety