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The difference between design for validation and clinical evaluation in medical device development
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We can find that design for validation and processing card paymentsclinical effectiveness evaluation are like other technical terms in medical device development, always too vague.

Let's take a look at the difference between thesportable containere two concepts below.

Definition

Design Validation - This is to verify that your medical medical device development processdevice meets the requirements of the specified end user. It is an element of design control, and the real point is to first prove that the product being developed is correct.

Validation reflects the effectiveness of your previous work. For example, the collection of user cases identifies the work done by the user. Basically, it is answering the question, "Does the equipment we are building meet the product specifications?

Clinical evaluation-This has a lot to do with designing for validation. In fact, clinical evaluation companies can develop as an important means of validating devices. But clinical evaluation in China has its own different meaning.

When analyzing information on non-exclusive products on the market for clinical effectiveness, the evaluation may be a comparison of data with other similar devices with similar uses to your device development or products with similar technology so that you can use the value assessment to demonstrate that your device meets national standards.

When a unique and innovative product requires clinical evaluation, you can perform a real-world use test or a simulated use test. Testing is multi-layered, but you need to understand the objectives involved in the evaluation and observe and analyze the responses of users (such as clinicians or end users).

The key difference between these two terms is that the design undergoes validation as part of the design can be controlled and is a necessary part of the product development work process before moving the product into a fully developed manufacturing enterprise. Clinical effectiveness assessment is used for social support system design validation activities, but is not always required.

Clinical evaluation of technical documentation

If you want to sell a medical device in the European market, then you will need to write a Clinical Effectiveness Evaluation (CER). This is part of the technical regulatory documentation that you need to submit. The EU has its own very specific requirements for clinical study evaluation documentation and review. The evaluation also includes devices that have a similar intended use to your device development and meet the basic competency requirements for the relevant national issues.

What is CE marking?

The CE mark is a product approval mark, which is an abbreviation of the French phrase "conformit éeurop éen".

When manufacturers put this mark on their products, it means that the products comply with the basic European regulations. These products can be legally placed on the market in their own country, while allowing the products to be freely transported and sold within the EU.

The preparation of technical documentation (or technical file) is an important part of the CE application process. For medical devices, the technical file must include the following elements in order to comply with the harmonized standards:

Product description and specifications

Manufacturing information

Risk management documentation

Design for verification and validation test analysis reports

Clinical evaluation

Labeling

As you can see from this, your clinical assessment is only part of the technical documentation requirements.

What is a clinical assessment report?

A clinical evaluation report documents the entire process of your clinical evaluation. The evaluation includes assessing and analyzing clinical data from the device to validate its safety and performance. The data used can be pre-market and post-market data relevant to the intended use validation, including device-specific data and any data relevant to the device for which the manufacturer claims equivalence.

The clinical effectiveness evaluation methodology includes: any of the key features of the design that raise particular performance or safety management issues; the intended use and application of the device; and our specific development requirements regarding the clinical performance and safety of the device. It is important to describe the strengths and limitations of any enterprise data cited or included in conducting the evaluation.

The manufacturer's risk assessment documentation is included in the review process to ensure that all identified risks are discussed and addressed or mitigated. During this process, the instructions for use of the equipment are reviewed to ensure that data for the same instructions are collected in the same manner from the population using the equipment, as described in the instructions. Finally, conclusions are drawn as to whether the essential requirements regarding clinical safety and performance are met.

Going back to the interrelationship between design validation and clinical evaluation, as we mentioned earlier, you can use clinical evaluation as part of design validation, an activity that takes place prior to marketing. Clinical evaluation is an ongoing process throughout the life cycle of a medical instrument, and after you complete the initial evaluation, you are required to re-evaluate if there is new clinical information (e.g., studies or use) or any changes to the instrument in order to obtain an approval score or meet the requirements of other regulatory agencies.

The difference between design and clinical evaluation is that the purpose of the evaluation and the relevant subjects of interest are different. Design validation is an internal design control requirement before a company goes to market to prove that the product developed is correct, while clinical evaluation can be used as a demonstration and experience for users before going to market. Unlike design validation, clinical evaluation is an ongoing cycle of activities that will continue post-market. The ultimate goal is to prove that your medical device is safe and effective.

Related article reading:

Medical device companies manufacturing: Medical device industry standards that are right for your product

Medical service devices for design: Are smaller and smaller instruments really better?

Medical device manufacturing: Using corporate products for life cycle to drive sustainability of medical devices in society


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