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
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
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)