8- New Product Introduction Validation Compliance

Operations and quality management of Medical Device 

Operations and quality management of Medical Device 



The client needed support in operations and quality management of new products: Developing and documenting the manufacture and critical processes.



Ultimate Solutions was able to provide them with resources on site that:

  • Participated in cross functional and cross divisional process improvement initiatives.
  • Provided engineering support for New Product and new process introduction.
  • Ensured that all activities were completed and documented in accordance with client New Product Development Process.
  • Generated and executed validations for equipment: custom fixtures, ultrasonic welding machine, packaging sealers, pneumatic swaging machine, plastic injection molds, glue application machine among others.
  • Validated critical processes: test methods, computer software (CSV), manufacturing process, sterilization, cleaning, safety, ergonomics, injection molding, and component validation at supplier.


The client was able to successfully launch products ensuring the quality of the processes.


Author: Omar Jorge, Sr Validation Engineer


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