Equipment validation

International standards (ISO13484: 2016, 21 CFR 820, etc.) for medical devices stipulate that it is necessary to validate the manufacturing processes of medical devices, where the resulting production of the process is not verified or can not be verified, by subsequent monitoring or measurement.
This implies activities not limited only to the validation of the process itself but also the activities that may 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 the validation activities, can support companies manufacturing medical devices, IVD or cosmetics, to:
  • Develop procedures and protocols for validating and revalidating equipment according to the IQ, OQ, PQ criteria
  • Develop a practical and efficient approach, proportionate to the impact of the equipment in the process
  • Maytal can provide support to the company in the application of the procedures for the validation, in drawing up the validation report, and in training the internal staff and
  • To train internal resources to ensure that the validation status is maintained correctly over time