Trainings - ISO & Regulatory Affairs (Medical & Pharmaceuticals)

 

TS Q & E Asia is proud to serve clients in Asia, especially United Arab Emirates, Saudi Arabia and other countries in Middle East. TS Q & E Asia takes the expertise from the TS Q & E, which is one of the leading training services providers in Italy, Switzerland and other countries in Europe. Our trainers are expert in developing customized training courses tailored as per organization’s need, can be delivered both live onsite or online. Moreover TS Q & E Asia also partners with an online training platform which is a product of TS Q & E- MDPharmacourses.com, where we sell our recorded webinars and online courses.

Some of the main training courses and services for this service are listed:

  • Onsite or Live Online Training for ISO 9001:2015 Internal Auditing
  • Onsite or Live Online Awareness Session on ISO 9001:2015
  • Onsite or Live Online Training for ISO 14001:2015 Internal Auditing
  • Onsite or Live Online Awareness Session on ISO 14001:2015 Internal Auditing
  • Onsite or Live Online Training for ISO 13485:2016 Internal Auditing
  • Onsite or Live Online Awareness Session on ISO 13485:2016

Since TS Q & E Asia share our services with MDPharmacourses.com, here are the list of some relevant recorded courses and webinars:

ISO 13485:2016 Medical Device QMS Transition Course 

ISO 13485:2016 Design and Development of Medical Devices

Regulation 745/2017 on Medical Devices Technical File Structure

Biological Safety Evaluation as per ISO 10993 Risk Approach 

Regulation 745/2017 on Medical Devices

Complaint Handling in Compliance with FDA ISO Regulations

Clinical Evaluation Literature Data According to MED DEV 2-7-1 Rev June 2016

UDI – Unique Device Identification as per new EU Medical Devices Regulation

510K FDA Registration

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