A subsidiary of TS Q & E Europe. Extending the consultancy and training business line to the important chunk of the globe i.e. Middle East, Central Asia, East Asia etc. and ultimately overall Asia will be covered under the scope of our services leveraging from the expertise of the European consultancy network for medical devices, mechanical industry and pharmaceutical industry.
We offer following different services under different domains:
-Medical Device Development
-Mechanical Design
-Pre-series and Prototype
-Usability & HFE
-Finite Element Analysis
-MDSAP – Medical Device Single Audit Program
-Quality System Support
-ISO 13485 Auditing Service
-SOP – IOP
-VMP IQ/OQ/PQ Validation
-Clean Room Design and Validation
-MDR 2017/745
-Technical File Design Dossier
-Clinical Evaluation
-DHF Design History File
-Risk Management Process
-ISO 14971:2012 Gap Analysis
-Design Control Process
-Cardiovascular Digital Simulation Model
-Registration to South America
-Gap Analysis for ISO 9001:2015
-Gap Analysis for ISO 14001:2015
-ISO 9001:2015 Stage-1 Audit Preparation
-ISO 14001:2015 Stage-1 Audit Preparation
-ISO 13485:2016 Stage-1 Audit Preparation
-Internal Auditing (ISO 9001:2015)
-Internal Auditing (ISO 14001:2015)
-Internal Auditing (ISO 13485:2016)
-Onsite Training for ISO 9001:2015 Internal Auditing
-Awareness Session on ISO 9001:2015
-Onsite Training for ISO 14001:2015 Internal Auditing
-Awareness Session on ISO 14001:2015 Internal Auditing
-Onsite Training for ISO 13485:2016 Internal Auditing
-Awareness Session on ISO 13485:2016
Company’s Keywords:
mechanical, medical devices, eu mdr, fda, iso 9001, iso 13485, pharma, manufacturing
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