In the following sections, we describe general considerations for process validation, the recommended stages of process validation, and specific activities for each stage in the product...

Dec 8, 2025 · Process validation is one of the most important quality requirements in medical device manufacturing. It ensures that a production process consistently produces components …

The Global Harmonization Task Force (GHTF) [3] defines process validation as ‘a term used in the medical device industry to indicate that a process has been subject to such scrutiny that …

Oct 17, 2024 · Process validation is essential when developing medical devices. This article covers when and why process validation is required.

May 28, 2024 · To properly complete process validation, manufacturers must carry out and document all three stages of IQ, OQ, and PQ on the equipment they will use to manufacture …

The goal of process validation is to produce a stable medical device manufacturing process that offers consistent performance. Variation is minimal and predictable.

Jun 13, 2025 · In this blog, we explain the evolving expectations for medical device process validation, 2025 compliance trends, and how manufacturers can safeguard product quality and …

Aug 13, 2024 · In this guide learn everything you need to know about medical device process verification and validation. Learn the differences and more, online.

Each manufacturer shall establish and maintain procedures for monitoring and control of process parameters for validated processes to ensure that the specified requirements continue to be met.

Meet FDA requirements and learn the principles and application of successful process validation. Whether you’re new to process validation, or seeking to refine your process, this practical …