a successful validation process
My experience has always been with design validation so I will only discuss that side. To have a successful design validation, the previous legwork needs to be done and done well. During the verification phase, there is still time to make changes. For example, let's say that during the test method development phase, the parts are shown to not meet the design specifications. This becomes a huge deal but at least the issues are discovered and addressed way before validation ensuring that they don't fail. If a design change due to the failure, all documentation on the product would need to be revised and it could lead to retesting in other areas if the change was large enough. Alternatively, the issue could just be test related, and the test may not even for the design specification or may not be isolating the product features necessary to determine if it meets the specs.
Additionally, similar to verification, the validation tests should be debugged before releasing for validation. Any test related issues can be corrected also ensuring that the validation is successful.
To summarize, having good prep work before the validation stage will more than likely result in a successful validation of the product.
I recently finished an internship with a medical device company and two of my projects involved drafting a validation. I have a few advices to successfully complete a validation.
1. Try to draft it asap and e-mail all the people you need approval from. This process takes so long since people can take awhile to get back to you.
2. Check for previous validations. For the most part another location may have the machine you are validating. Ask to see their validation so you can use it as a template.
3. Draft the protocol. Start to collect the amount of parts needed for the protocol.
A successful validation process for a medical device requires the medical device is typically matching the user needs. In validation, there are some obstacles that may face this process. These obstacles need to be avoided. First, communication lag may put off validation process even if all others aspects are done properly. Also, unclear device usage may take time during validation tests or the tests may be repeated for many time to check the customer needs.
Some ways to make validation pitfalls is to miss parts of the process, skip testing, excluding the packaging and labeling. To make Validation right, Your design validation process must include initial production units meaning to have the device built in the same production environment, Design validation must involve clinical evaluation, Use the medical device under the specific, intended environmental conditions, and last but not least Keep your design records organized, which a good quality management system will help you achieve.
A successful validation program brings together engineering, manufacturing, regulatory compliance, and quality assurance to develop test solutions that are unique to each application. Developers of medical devices must validate the product design to ensure that it meets the user's requirements. It should revolve around the patient by ensuring that the medical device under development meets the user's needs. If the patient is not satisfied with the performance of a clinical device, then validation will have to re-examine the specifications of the device and perform verification again. An important aspect of design validation, as mentioned in lecture, is the application of clinical human studies in order to analyze how a demographic of patients respond to the applied medical device. A successful validation process will make sure to follow all the company and the FDA rules and will ensure that the user needs and the company's needs are met.