Quality Management System

A Quality Management System (QMS) enables a company to be compliant with the relevant medical device regulations. The ultimate goal of a QMS is to ensure that all processes are optimized to guarantee the essential performance, i.e. the safety and effectiveness, of the product(s). 

TAKSO can create, in co-operation with the customer, a completely new and customized Quality Management System to match the regulatory needs and dedicated requirements of the company. A Quality Management System comprises a QMS manual explaining all the company’s processes, work instructions, document templates and registers. We can also help customers modify an existing QMS to meet the latest regulatory requirements.

TAKSO Services:

• Creating a new Quality Management System including the relevant processes
• Developing a QMS
  • Updating the QMS manual
  • Updating processes
  • Work instructions, document templates and registers
  • Implementing new regulatory requirements
•  QMS training
  • General introductions
  • Deep-dive training for special issues
  • Individual/group trainings
•  QMS auditing services

TAKSO's experience in Quality Management Systems benefits both start-ups and global giants.

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