Process Validation

International standards (ISO 13485:2016, 21 CFR 820, etc.) for medical devices require validation of manufacturing processes where the resulting output cannot be fully verified through subsequent monitoring or measurement.

These activities are not limited to process validation but may also include equipment validation, process software validation, and test method validation.

With over a decade of experience in validation activities, Maytal can support manufacturers of medical devices, IVDs, and cosmetics to:

• Develop equipment validation and revalidation procedures and protocols according to IQ, OQ, and PQ criteria

• Implement a practical and efficient approach, proportionate to the equipment’s impact on the process

• Support the company in executing validation procedures, preparing validation reports, and guiding/training internal personnel

• Train internal resources to ensure that the validated status of equipment is properly maintained over time