Process Validation

International regulations for medical devices prescribe that it is necessary to validate the manufacturing processes for medical devices, in which the resulting production of the process is not verified or can not be verified, through subsequent monitoring or measurement (eg packaging, sterilization, washing, etc.).
This implies activities not limited only to the validation of the process itself but the activities that may also include equipment validation, validation of the software used in the process and validation of the test method.
Maytal, thanks to more than ten years of experience in validation activities, can support companies manufacturing medical devices, IVD or cosmetics:
  • to develop validation and revalidation procedures and protocols of the main processes that require validation such as e.g. shelf-life and packaging, sterilization, washing, stability, etc.
  • Maytal can provide support to the company in the application of the procedures for the validation, in drawing up the validation report, in training, the internal staff and to
  • train internal resources to ensure that the process validation is maintained correctly over time.