| The organization is required to perform verification and validaton activities over the design and the development processes. You had performed design and development activities and now it's time to verify and validat that the development is advancing according to plan. Which plan? The same one defined through chapter 7.3.1. So,
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The Design and development verification | ISO 9001 | ISO 13485
| The verification of the design and the development processes are to be performed according to the development activities.
| The verification of the design and the development processes are to be performed according to the development activities.
| The verification shall evaluate the adequacy of the design and the development outputs to the inputs requirements.
| The verification shall evaluate the adequacy of the design and the development outputs to the inputs requirements.
| The organization must keep records of the design and the development verification. These records must be defined as quality records within your records control procedure as mention in paragraph 4.2.4 – control of records.
| The organization must keep records of the design and the development verification. These records must be defined as quality records within your records control procedure as mention in paragraph 4.2.4 – control of records.
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The verification activities' purpose is to ensure that the design and the development are progressing according to defined outputs. The verifications activities are to be included throughout the design and the development plan. The verification shall be performed during the development processes (and not after, surely not before….). The verification may include review outputs, analysis, simulations, or comparisons. Records of verification activities shall include the results of the verification activities and non conformities, when such occur. Let's hope they would not, because than you would have to include (that means to record) the corrective action taken to eliminate the non conformity. As mentioned above the records of the verification shall be included under the records control process of your organization. Design and development validation The organization must validate the development to ensure that the resulting product meets the requirements. While validating, the organization must refer to the next issues: ISO 9001
| ISO 13485
| The organization is required to define a method to validate that the product was developed according to the requirements.
| The organization is required to define a method to validate that the product was developed according to the requirements.
| The organization must review the product's functionalities to see that they are as expected.
| The organization must review the product's functionalities to see that they are as expected.
| The validation process would take place prior to the releasing of the product.
| The validation process would take place prior to the releasing of the product.
| | | Where the product can be validated only after delivery or installation, delivery process would be defined only after validation of the product was completed.
| | | Where regional or regulatory requirements require performing clinical or medical evaluations, these one would be regarded as part of the products validation. The product would not be release prior to the performance these requirements and the evaluation shall be considered as product delivery.
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Validation means to control the developed medical device and evaluate whether it achieves the intended use requirements: customers' requirements, legal requirements, marketing requirement etc. This validation shall be one of the design and the development plan milestones. There are cases where the organization is unable to validate to the product in the developing environment before releasing and delivering it to the customer. This may occur because the product requires an installation process or a special environment to function. In such cases the organization shall validate the product where it supposes to function. In any case releasing and delivering the product to the customer would be considered completed only after the product was validated (in the development environment or at the customer's locations). In other words, you may hand over physically the medical device to your customer, get the money and say thank you, but as far as the ISO 13485 Standard concerns, delivering would be considered completed only after you validated that the medical device had achieved its intended requirements. For example, if the organization develops a medical equipment for performing operations within a certain hospital. Part of the characterization is according to the hospital's requirements: size of the room, electricity requirement, trainings etc. – subjects which can be completed only after delivering physically the medical device and take place at the customer's location. In such case, delivering this equipment would be completed only after the installation and the validation that this medical device was developed according to the requirements. Another additional requirement is for validation requirements as dictated by any regulatory or regional requirement. When defining the validation process, the organization must refer to these requirements and include them within the design and the development plan. Let go back to the operation room. The organization supplied the equipment validated its intended use, performed the required trainings and everybody is satisfied. But the local regime requires that its representative would inspect the medical device and generate a certificate declaring that the equipment is ready for use. You must include this process throughout you design and developing plan as one of the validation processes. |