Our Services

validation Testing

Validations:We provide special process validation services, organization requiring help in Sterilization Validation such as Ethylene Oxide (EO), Gamma (Irradiation), Steam (Autoclave), Clean Room Validations.

​EO Sterilization Validation

Gamma Sterilization Validation

Steam Sterilization Validation

Process Validations

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

Training

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

ISO 9001, ISO 14001, ISO 13485, OHSAS 18001, ISO 20000, ISO 20000, ISO 22000, ISO 27001, ISO 50001, ISO/TS 16959, ISO 20252. Consultancy services are aimed to achieve intended benefits of relevant ISO standard which is implemented in the organization.

CE marking in Medical directive, In-vitro Diagnostics Directive, Active Implantable Directive, Machinery Directive, Low Voltage Directive, Electromagnetic Induction Directive, Pressure Equipment Directive, Radio Telecommunication Directive & ATEX Directive.

Consultation & Certification

Management System –​ ISO 9001, AS 9001, ICMED 9001, ISO 13485, ICMED 13485, ICMED 13485 Plus, ISO 14001, ISO 18001, ISO 20000, etc..

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  etc…

Russian Approvals – TR CU (EAC Declaration & EAC Certificate)