Hi-Tech provides expert guidance on the best way to execute your qualifications, verifications, or OQ/PQ validation runs, depending on your medical die cutting project needs.
Hi-Tech can walk you through the process, explain how each step works and which methodology will best answer your needs based on the product type, intended market, classification, regulatory requirements, and risk of your specific product. We can handle the entire project from writing the OQ/PQ Protocols, getting your approval, executing the validation, testing the parts, and writing the final reports, or we can execute your Validation Plan and provide you with the data and documentation you need. We have over 20 years experience in meeting regulatory requirements for many medical industries and many different regulatory standards. Whether you need a simple qualification run, a full OQ/PQ Validation for a regulatory filing, or something in between, we can do that for you. Just tell us what you believe your needs are and we will present you with your best options based on our years of experience.