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Medical Device Manufacturing

Manufacturing Documentation

Manufacturing Documentation

Developing manufacturing documentation and a quality system that is compliant, efficient, and easy to maintain as you grow can be a burdensome effort which, if done improperly, can lead to severe consequences.

Partnering with LSO provides you access to manufacturing documentation and a quality system that has been audited by the FDA, and is reviewed and audited over 50 times a year by our customers. Because of this experience and the fact that we are building from this extensively audited quality system, the manufacturing documentation we develop is efficient and easy to use, while exceeding industry and regulatory standards.

Our quality and process engineers can build customized manufacturing documentation that meets you specific needs, as well as allow your company to tap into existing documentation and processes.

Manufacturing Documentation Services

Our intention is to enhance value for customers by optimizing manufacturing processes and strengthening deficient areas. A comprehensive list of all our Engineering Services is provided below:

  • Development of customized documentation
  • Process development
  • Implementation and adoption into practice
  • Training of personnel - including ISO 13485, FDA QSR (GMPs), Corrective Actions
  • Continuous Improvement/Gap Assessments - including ISO 13485, FDA QSR (GMPs)