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Medical Device Consulting

Contact | Medical Device Consulting

Markku Nieminen
+358 40 723 7050

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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