Process Validation

NextPhase has a long history of medical device validation, and we’re ready to help ensure that your product meets requirements. Medical devices are what we do, so validation conformance to FDA, MDD, and ISO standards is second nature. It’s likely that we already have experience with the processes you have in mind and have designed, executed, and documented a similar protocol that we can leverage efficiently in getting the job done for you.

Validation protocols

Every week customers come to us with new concepts ready for manufacturing, so our engineers are also skilled at developing protocols for innovative processes.

We can help you with your protocol and test development, execution, data analysis, and report generation. You’ll receive an effective, relevant, and well-documented validation plan and reports that meet all regulatory requirements.