Validation and verification are both lengthy tasks that could possibly take longer than the scheduled outline for the project. When validating a project you are insuring that that the functional requirements of the project are in order to work. If these requirements do not work, the risk would include a failed project with errors that could result in a negative feedback about the company. The verification comes before the complete development of the project. Therefore if there is an error within the verifying process then the action that is taken for the project could possibly discourage stakeholders, and team members.
Validation and verification are two independent procedures used in conjunction to check that a product, service, or system meets the requirements and specifications for its intended purpose and assures that it meets the needs of the customer and other identified stakeholders. These crucial components of the quality management system must be effectively carried out and managed. If a company decides to carry out the process of validation and verification themselves, there are many risks to consider. One risk is to ensure that there are proper metrics in place to attain proper analysis and another is to ensure proper testing and evaluation. If these systems are not properly performed, this could have extreme ramifications. To mitigate these risks, many companies hire independent validation and verification firms to produce unbiased findings.
Verification and validation are both elements of the medical device testing process, they serve two very different but equally essential functions. In simple terms, verification determines whether the product was built right, while validation determines whether the right product was built. Verification tests whether your design outputs match your design inputs. Validation, on the other hand, is the testing process that proves the device built works as intended for the consumer.
The risk I see in the validation and verification process can be centered around timing. From that risk, it can stem various issues. If this process were not to be done or to be done with no regard to the details, then it can cause the company to lose money due to the product failing and the back-tracing that will follow. On the other hand, the process can take so long that the company will lose out on money as well. Delays will mount up to the point that the interest in your device will steadily decline.
V&V is typically a huge part of the project timeline and is crucial to the creation of safe and effective medical devices. There are many associated risks on project management when thinking about V&V. I think first and foremost there must be a well assessed timeline put in place for V&V. If this process is rushed or is unorganized it may lead to mistakes being made and not enough quality data to support the design requirements. Additionally, if the V&V studies are not well planned then it may lead to huge setbacks on the timeline. Hopefully these mistakes would be caught in real time so they could be addressed by the project team before FDA submission. In the worst-case, mistakes would be caught by the FDA resulting in further investigations of the product and a resubmission to the FDA (probably under more scrutiny). This would cost the company a huge amount of time and money. The medical device industry is extremely fast paced and there are so many companies competing for the same space in the market. If the risks are not properly foreseen and addressed in the V&V process, then it may adversely affect the timeline which may prevent your company from bringing that product to market.
