Many successful Silicon Valley medical device product development companies, including Pro Engineer Portal, perform design verification and validation studies. This helps identify design deficiencies before new product specifications are transferred to large-scale commercial production.



Verification and Validation for Silicon Valley medical product development companies

When employed early in the product lifecycle, Real-time Independent Verification and Validation (IV&V) demonstrate compliance and spotlight issues during the testing phase prior to end users having a problem. The Real-time approach ensures documentation, focus, and cost of testing is suitable. Furthermore, determining issues early results in correction before failures can occur on the production line or in the field. The results of which are often “saving face” and money.

We know that Verification and Validation are integral processes in the life cycle of a product. Companies are mandated to perform validation processes on regulated products. This mandate means much effort must be put into ensuring the product performs in a consistent manner that meets the pre-determined Smart Requirements or Specifications and quality attributes.

Our processes are well established and precise, involving a well-developed service framework for Verification and Validation.



Verification are we building the product right

Verification -“Are we building the product right?”

Verification is used to evaluate a system or its components and determine whether or not they are meeting defined smart requirements. Verification is also a quality control method during which a project’s processes are examined and reviewed by the IV and V team. The purpose is to spot problems, prevent omissions, and ensure the product is being correctly developed. Activities in this method of evaluation may encompass: Verifying Smart Requirements against specifications, verifying design against smart requirements, verifying product code against specific standards, and verification of conditions, payment, terms, etc., against contracts.

Validation -“Are we building the right product?”

During the Validation process the goal is to document evidence that establishes the product or service provides the highest degree of assurance and accomplishes the intended smart requirements, thus validating that it will do what the end user is expecting it to do.

First, we must ensure the requirements have been properly defined, that the functionality and design follow the requirements, that test results are exact, and the data is treated correctly. The dynamic testing approach in which the physical response of the product is tested while exposed to changing variables is commonly used. This form of testing can have many phases and ensures the output of the product is as expected. Some phases may include: Integration testing, Unit testing, Function testing, System testing, User acceptance and Black-box testing.



Validation are we building the right product

Verification

The process by which use of provision of objective evidence and examination to prove a particular requirement has been fulfilled.

Validation

The process of confirming by use of provision of objective evidence and examination to prove a particular requirement for a specified use can be fulfilled on a consistent basis.

Verification and validation studies both provide objective evidence that the output of a development effort is, in fact, what was needed and requested.

Together, product design verification and design validation studies demonstrate that the output of the product development efforts meets internal technical and external client expectations.



The important distinction between verification and validation is precisely what is being confirmed. FDA definitions indicate that verification studies focus on demonstrating that specified technical requirements, such as those contained in a product specification, have been fulfilled, while validation studies focus on demonstrating that the intended use, which is defined by the user, can be consistently achieved.


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