Product development cycle, validation requirements

TABLE II Validation Required at Each Stage of the Product Development Cycle... 

Each requirement for a medical device has to be written in such a way that it is testable. At the end of the development cycle, verification and validation of the product has to be performed. This is meant to guarantee that the product developed is the product desired by the user. The verification step is simplified if the requirement specification is written in a form that every requirement is testable. Therefore, the test department is included in the process of writing the requirements. In generating a model and in writing the requirements in a testable way, the test department can plan and develop tests for the system verification phase. Having the tests be developed in parallel to the system itself saves valuable time and leads to shorter time to market. The verification phase is usually followed by a validation phase. This validation phase is somewhat comparable to a beta test phase common with software products. The devices are given to a defined number of users for validation. Of course, this phase should not lead to requirement changes. 

For meaningful safety-related product development not any quality characteristics could apply their own process. Therefor also even if there are other means of analysis or methods for verification or validation necessary, it is a matter of tailoring of the product lie-cycle to apply activities to as necessary for all non-functional requirements also such as securily. Similar to challenges with the safety lifecycle for safety-related active safety functions and other passive safety functions the tailoring and even the entry into the safely lifecycle is dilferent. The intended safety function for an active safety function should be made safe by adequate measures during the Item Definition, and for typical passive safety functions it should be done during entire safely lifecycle. 

Risk is an inherent part of plastic product development, and the level of risk can actually increase as plastic part designs become more efficient. The reason is that as the plastic part designer improves the design, more constraints on the design become discovered. The use of 3D printing does not eliminate risk as described in Section 27.4, but only changes the nature of the risk. Validation cycles are still required to ensure that the 3D printed components have... 

It is expected that different companies will develop different levels of process understanding and the level of understanding for a particular product can increase over time (life cycle). These differences will need to be accommodated in regulatory policies through a clear articulation of what is a minimum regulatory expectation (e.g., current requirements of CMC review information and process validation) and what is an optional opportunity for companies to improve efficiency while reducing risk to quality and regulatory concerns. 

Enhanced turn-over package Installation qualification protocols Operational qualification protocols Change control initiation Cycle development Performance qualification protocol Process validation protocols Validation final reports Validation package Certificate for use in manufacturing Required protocols and procedures for dry production Required protocols and procedures for liquid and semisolid products... 

Both approaches require some estimation of product bioburden. It is not advisable for ethylene oxide sterilization processes to be validated without at least some estimates of numbers of product contaminants. This is irrespective of whether cycle development is by the so-called overkill or the so-called bio-burden method (see below). 

To make Scrum conform to lEC 61508, the final validation in each iteration should be done both as a validation of the functional requirements and as a RAMS (Reliability, Availability, Maintainability, and Safety) validation, to address specific safety issues. If appropriate, the independent safety validator should take part in this validation for each sprint. If we discover deviations from the relevant standards, the assessor should be involved as quickly as possible as he is normally not involved in the validation for each sprint. Using an iterative and incremental approach means that the development project can be continuously re-planned based on the most recent experience with the growing product. This principle is related to the well-known principle of the Deming/Shewhart cycle [18]. Between the iterations, it is the duty of the customer or product owner to use the most recent experience to re-prioritize the product backlogs. 

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