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If you need help with any medical device process validation, then we can help. Peter Turk has over 28 years in the medical device market. His expertise includes manufacturing engineering support, research and development into new and/or improved polymer processing, manufacturing and extrusion production methods, management of projects related to the development of medical devices and accessories - along with setup and validation of extrusion and clean room activities. Contact us to get in support you need to move your medical device forward to FDA acceptance.
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What is Process Validation?
Medical device process validation is gathering and assessing of data, from the process design stage to the production, which displays scientific proof that a process is adept to incessantly providing quality products. Process validation is recorded with protocol and a final report with several other documents. The objective of process validation is establishing manufacturability, quality, safety and efficacy of the final product.
A complete validation will also include the creation of a robust process FMEA (pFMEA) document, updated training, gage R&R’s, test method validations, updates to manufacturing procedures, and resource management setup (ERP such as SAP, QAD, etc.) to name a few.
A complete validation will also include the creation of a robust process FMEA (pFMEA) document, updated training, gage R&R’s, test method validations, updates to manufacturing procedures, and resource management setup (ERP such as SAP, QAD, etc.) to name a few.
Different Types of Process Validation
There are a couple of different process validations that vary from one to the next based on what stage of the production lifecycle is at.
