Validation Services
Typically, design validation involves a series of tests and experiments to validate the functionality, performance, and safety of the product according to expectations. However, there are also other acceptable validation activities, such as inspections and analyses. This means that design validation is not limited to testing and experiments alone but can include activities such as reviewing design documents, preparing validation reports, and conducting other forms of analysis to confirm whether the product meets the expected requirements. For more detailed information on acceptable validation activities and methods, please refer to page 30 of the FDA Design Control Guidance.
Design validation is one of the crucial steps in the process of developing medical devices. Its purpose is to verify whether the design and development output of a product meet the requirements set by the design and development input, ensuring that the development work achieves the expected effectiveness, safety, and reliability. Specifically, design validation involves examining and providing objective evidence to confirm that the product meets the specified requirements.
In the 21 CFR Part 820.3 of the United States FDA regulations, validation is defined as a method of confirming that specified requirements have been fulfilled through examination and provision of objective evidence. In other words, design validation is the process of ensuring that the design output of a product complies with the design input, which represents the specified requirements.
Design Transfer
All medical products go through a life cycle. The analogy is apt. Not only does each product’s life cycle have different phases, such as proof-of-principle, engineering prototype, and commercial product, but there are also different and critical transitions between each of these phases that determine the ultimate success of the product. Among these transitions, design transfer, i.e., the introduction of a design into production, is probably the most important. Effective design transfer requires a thorough evaluation of the product’s design documentation, selection of components, and careful definition of production methods. Failure to transfer designs effectively can result in situations where specified parts are unavailable or cost more than expected, production workflow is disrupted, and product quality is compromised. Conversely, the rewards of effective design transfer are enormous: it reduces material and production costs, shortens time-to-market, improves product quality, and inspires customer enthusiasm.
Design transfer is an integral process in the early life cycle of a product. It must be well executed, especially for complex medical devices.The FDA’s Quality System Regulations require manufacturers to complete the following steps to satisfactorily complete the design transfer process:
- Establish and maintain procedures to ensure that equipment designs (its components and configurations) are correctly converted to production specifications；
- Translate product design into production methods and procedures；
- Creating a manufacturing environment that ensures product compliance with regulatory requirements and industry standards
Test Protocol
The purpose of the test protocol is to provide a method for successful testing of medical devices. The results of the test protocol will be documented in a test report. For mature medical devices or technologies, standards organizations such as the FDA and ISO have defined standard methods for how to test products. However, for new technologies in medical devices, manufacturers need to define how to conduct testing. Testing can cover all aspects of a medical device, including biocompatibility, packaging, labeling, clinical use, and design output. By implementing testing protocols, manufacturers can confirm the performance and compliance of a device in different aspects to ensure it is safe and effective for its intended use.
In the testing protocol, the manufacturer should specify the objectives, methods, benchmarks, and evaluation of results of the testing. The objectives of testing should be consistent with the intended use and performance indicators of the device. Testing methods should include laboratory testing, clinical trials, user evaluations, etc. to ensure that all aspects of testing needs are covered. When developing test protocols, manufacturers should also consider applicable regulatory and standards requirements and ensure that the test results meet those requirements.
Clinical Trials
Obtaining approval for a new product or therapy requires reliable clinical evidence. Relatedly, medical device sponsors are well aware that the regulatory approval process can become very difficult without adequate clinical evidence to support the effectiveness and safety of the product. As a result, clinical trial consulting services have become a critical component. The clinical trial consulting expertise we offer covers a wide range of technologies, therapies, indications and geographic locations. We have extensive experience in successfully guiding our clients through all phases of clinical studies, from first-in-human trials to pivotal trials to post-marketing surveillance. Our clinical testing services include, but are not limited to, the following:
- Provide practical advice on the design of clinical studies: Our team of experts will provide clients with targeted design advice based on the purpose of the study and the expected results to ensure the reliability and validity of the trial process.
- Cost Estimates: We are able to help our clients estimate the cost of a clinical trial and provide a detailed cost analysis to ensure clear budget planning.
- Draft IDE (Investigational Device Exemption) submissions, including protocol summaries: Our team can assist clients in preparing the relevant documentation required for IDE submissions, including full study protocol summaries, to ensure compliance with regulatory agency requirements.
- Participate in Pre-IDE interactions with the FDA: We are able to help our clients engage in effective Pre-IDE interactions with the FDA to address and clarify any concerns or questions to ensure a smooth study program.