Services
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Factory Quality Management System Certification
Factory Quality Management System Certification (ISO 9001, ISO 13485, MDSAP, etc)
Product Testing
Conduct in-house and external product testing to meet global standards.
Product Inspection
Large scale glove inspection to ensure continuous high quality production.
Technical File Write-up
We provide technical file write-up for various industries such as manufacturing, engineering and trading.
FDA 510K application & approval
We can assist and guide businesses on FDA 510K application.
Product Certification
CE Self Certification and EC-Type Examination Certificate. Medical Device Registration with MDA, MDA – GDPMD, Japanese PMDA. SMG Certification, Medical Device License by Health Canada
Risk Assessment
We conduct training on Risk Assessment & Management for various business fields.
Quality Management Systems related trainings
Training & Courses on ISO 9001 & ISO 13485 Quality Management System related trainings.