One of the cornerstones of medical device manufacturing is the ability to efficiently and cost-effectively validate medical devices to ensure FDA compliance and to successfully and profitably bring medical products to market. Proper validation is a core requirement for any medical device manufacturer looking to achieve regulatory agency compliance and sell their products domestically and internationally.
At MEDIcept, we understand that medical device testing is a rigorous and complex process that can reduce risk for both the device manufacturer and potential investors. It is critical to ensure that all engineering documentation is complete and accurate and that the manufacturer can validate that the product works as claimed. If they fail to implement a successful validation program, their ability to produce and sell medical products is put in jeopardy. That, in turn, impacts their value as a business.
At our state-of-the-art testing facility we can help develop and implement qualification testing and process validation protocols and reports for packaging and aging qualifications, sterilization validations, and biocompatibility testing suitable for regulatory submissions. These same testing services can also be conducted at your facility on your processing equipment.
We’re experienced in validating many types of equipment, processes and systems used in a wide range of medical device manufacturing. Our in-depth understanding of regulatory and clinical strategies and what it takes to bring a medical product to market enables us to assist manufacturers in developing reliable, compliant validation programs to help gain FDA product approval.
If you’re a medical device manufacturer – or looking to invest in one – we invite you to contact us to learn more about our proven medical device validation services.