KR20230118407A - Equipment design support system with standard application guide function - Google Patents

Abstract

This invention relates to a device design support system with a standard application guide function. When planning design of a device applied to a strict standard such as medical devices, the device design support system confirms contents of a test report form through a question and answer method so that researchers can resolve the difficulties of defining and applying standards during design. The present invention supports the creation of product requirements (product requirement specification) and functional requirements (functional requirement specification) so that each content can be reflected in design specifications.

Description

Equipment design support system with standard application guide function}

The present invention relates to a design support system, and more specifically, a test report form (Test Report Form (hereinafter referred to as 'TRF') and supports the creation of Product Requirement Specification (hereinafter referred to as 'PRS') and Functional Requirement Specification (hereinafter referred to as 'FRS') to ensure that each content conforms to the design specification. It relates to a device design support system having a standard application guide function that enables reflection.

As the MDR, a European medical device corporation, has recently started, and as surveillance on maintaining clinical safety and effectiveness of pre-market approval and post-market medical devices has been strengthened, manufacturers properly know product specifications and process specifications and reflect them in product design plans. Therefore, verification must be conducted after design to respond to pre-market and post-market regulations.

However, the laws and standards of medical devices are more difficult than expected, and there are parts that even the most knowledgeable designers do not know. problem existed.

Certification was possible in the days of MDD, when only documentary evidence or records of past requirements were required. It is evaluated and evaluated for whether it can be improved. Naturally, the higher the risk level, the greater the severity because more expertise is required.

Analyzing the reasons why medical devices were recalled by the FDA, design errors accounted for 31%, manufacturing errors 24%, and parts or module suppliers errors 12%. The most likely cause is the non-compliance with standards. The second largest part is the software part, which is a problem caused by not properly performing the software life cycle process and software validation. This, too, is caused by a lack of adherence to standards. The third is process design, which also occurs when process standards (software, risk management, usability, sterilization, etc.) are not properly followed. A fourth component design is also mentioned in the standard.

From now on, if these standards are not properly followed, CE (MDR/IVDR) and FDA cannot be obtained, and Korea has no choice but to participate in these regulations as long as it has joined IMDRF, but it is still difficult to write a design plan using medical device standards. It is difficult to understand the standard as many researchers complain of difficulties, but even if they understand it, they are having greater difficulties in applying it.

Republic of Korea Patent Publication No. 10-2020-0019180 (2020.02.21)

The present invention was created to solve the above problems, and the object of the present invention is to establish hazard factors, test standards and methods that are easily explained and included in standard information when designing devices to which strict standards are applied, such as medical devices. It is to provide a device design support system with a standard application guide function that supports the easy creation of a design plan that conforms to the standard by supporting it.

For the above purpose, the present invention provides a database storing standard information including standards and appendices containing risk factors, test standards, and test methods; An information support module that provides browsing, search, and index functions of the standard information, but classifies and displays hazard factors, test standards, and test methods; A PRS creation module that presents whether or not the product under design corresponds to the above risk factors in the form of a question and receives a selected answer, but creates product requirements based on the risk factor corresponding to the selected answer; An FRS creation module that classifies products under design by module and creates functional requirements by applying the product requirements to each classified module; A plan writing module for preparing a design plan by arranging risk factors corresponding to the product requirements and functional requirements for each module while receiving basic information of the company, product, and person in charge; It is characterized by having a.

At this time, it is preferable that the standard information includes standard annexes and guidelines for additional interpretation, and supports a shortcut menu corresponding to the guidelines through the information support module.

In addition, a detailed confirmation unit that checks whether hazardous situations related to hazard factors, acceptance criteria, and test methods are mentioned in the standard information, and test standards and test methods for unconfirmed hazardous situations, acceptance criteria, and test methods are input. An RMF creation module having a detailed input unit to create a risk management file; It is preferable to further include.

In addition, it is preferable that the FRS creation module is configured to provide examples related to functional requirements and to support creation according to the examples.

In addition, a tracking module that enables history management by assigning serial numbers to standard information, product requirements, and functional requirements related to products under design; It is preferable to further include.

Through the present invention, many companies and researchers having difficulties in preparing design plans using medical device standards can easily understand the standards and apply them to product design.

In particular, the PRS is written in the form of answering questions that solve the TRF content, which was difficult for researchers to easily understand because the content was too concise. support to write

In addition, if a risk management process is requested, templates and examples are provided to create a Risk Management File (RMF), and numerous standard items can be directly included in the design plan for each medical device module. Make design plans easy to create.

1 is a flow chart showing a product design process;
2 is a block diagram showing the configuration and connection relationship according to an embodiment of the present invention;
3 is a driving screen of an information support module according to an embodiment of the present invention;
4 is an additional analysis screen according to an embodiment of the present invention;
5 is a display screen of hazard factors according to an embodiment of the present invention;
6 is a conceptual diagram of RMF creation according to an embodiment of the present invention;
7 is a TRF question screen according to an embodiment of the present invention;
8 is a PRS generation screen according to an embodiment of the present invention;
9 is an RMF question screen according to an embodiment of the present invention;
10 is an RMF input screen according to an embodiment of the present invention;
11 is an FRS and V&V creation screen according to an embodiment of the present invention;
12 is an initial information setting screen according to an embodiment of the present invention.

Hereinafter, the configuration of a device design support system having a standard application guide function of the present invention will be described in detail with reference to the accompanying drawings.

The process for designing a device by applying the strengthened standard (specification) is as follows.

Basically, the standard mentions the hazard factors, and since a lot of risk is caused by certain hazard factors in the design/production/sale of equipment, the company's know-how to consider these hazard factors before design is included in the standard.

In addition, by presenting the test standards to avoid the risks caused by these hazard factors, it is guaranteed that such risks do not occur if they are satisfied. In other words, it proposes test standards that do not cause unacceptable risks, and requires risk management to satisfy those standards in practice.

For example, IEC 60601-1 standard 4.3 Essential Performance states that “During the risk analysis, the manufacturer must determine the clinical aspects of the ME EQUIPMENT and ME SYSTEM, in addition to BASIC SAFETY, that are necessary to achieve the INTENDED USE or that affect the safety of the ME EQUIPMENT and ME SYSTEM. The performance of the function must be identified.", and it is important to understand the contents of the hazard factors, test standards, and test methods while looking at the standards.

In other words, the standard contains a lot of content, and practically everything must be followed, but among them, the content to be checked is included in the TRF (Test Report Form), and the test report is issued using this TRF.

Therefore, the manufacturer must check whether the risk factor/test method in this TRF is applicable to the product, and if so, design it to pass the test and confirm the test operation. However, TRF does not exist in all standards.

A design plan is required for product design, and for the design required by the aforementioned GMP, formative evaluation of usability must be performed, risk management must be performed, and this must be reflected in the design input. In general, three contents of performance, function, and safety/reliability are recorded in the design plan. Since most companies perform the design plan for performance and function without much difficulty, in the present invention, the design reflecting the contents of the standard for safety Assist in drafting the plan.

The Product Requirement Specification (PRS) required for this is, if there is applicable content in the TRF, it is required to satisfy the test criteria presented to reduce the risk due to hazard factors, or if the test criteria are not presented, the risk This is a document prepared to design using risk control measures that reduce risks through management processes.

Since there are such hazards mainly at the team leader level, it is written to reduce the risk, and the same design is written regardless of the product, and the design applied to the actual product is written in FRS.

Examples: (essential performance) 1. During the risk analysis, the performance of clinical functions that are necessary to achieve the intended use or that affect the safety of the ME EQUIPMENT and ME SYSTEM is identified according to ISO 14971 4.2 to 4.3 and an RMF is prepared. (In the clinical function table, ISO 14971 4.2 - Intended use, 4.3 - Hazard factors/hazardous situations should be written and managed in the RMF, and the RMF should be shown.)

Functional Requirement Specification (FRS) is a document prepared by a responsible researcher to implement a functional design that satisfies the test criteria in an actual product or a risk control method selected in RMF. Functional design means that certain functions must operate to prevent hazardous situations and risks in actual products.

Example: (For X-ray equipment) The contrast width of an image varies according to kVp. Misdiagnosis can be made because the lesion signal that exists outside the contrast width of the image cannot be imaged due to the wrong tube voltage. Because it is a dangerous clinical function, record it in the attached table 4.3 and record it as the contents of 4.2 and 4.3 of the RMF.

The Detailed Design Specification describes the details of the actual circuit or software design of the function described in the FRS.

Example: Design a table chart with software so that the required tube voltage can be selected by AEC automatic mode from the tissue mass absorption coefficient chart to create an accurate contrast width of the image in the area to be seen/

Verification & Validation (V&V) is a test process to find out whether the means and goals have been properly implemented, and Validation is a validation process. It is an evaluation of whether the actual goal has been achieved.

Whenever a design plan comes out, a test plan must come out accordingly, and a product made according to the detailed design plan must be tested to produce a V&V report. A Verification Plan for the design must accompany it.

Figure 1 is a flow chart showing the product design process, showing a series of processes for creating a design plan, PRS / RMF / FRS, and test plan from the risk factors mentioned in the standard. As a block diagram showing the configuration and connection relationship, the present invention is a configuration for supporting product design through the aforementioned process, and includes a database, an information support module, a PRS creation module, an RMF creation module, an FRS creation module, It indicates that a tracking module and a plan writing module are provided.

The database 110 is a configuration for storing standard information including standards and appendices containing risk factors, test criteria, and test methods, and the information support module 120 provides browsing, search, and index functions of the standard information. However, it is a configuration that shows hazard factors, test standards, and test methods by classifying them.

For reference, in the present invention, it is expressed as a standard, but a standard that is a concept similar to this exists. Specifications and standards are similar, but standards are a more strict concept. If the law (notice in Korea) states that this standard must be followed, the standard becomes a standard, and it is a rule that stipulates the minimum that must be observed among interested parties. .

In IEC 60601-1, which is a representative standard, there are about 1,400 of the approximately 2,000 hazard factors that must be tested.

3 is a driving screen of an information support module according to an embodiment of the present invention, providing browsing, searching and indexing functions of standard information stored in the database 110, but showing hazard factors, test standards and test methods separately, there is.

In other words, it shows the contents of the standard by table of contents, and allows you to find where these words are in the standard through the search function. In addition, among the contents of the standard, the contents required to be performed in the TRF, that is, hazard factors, test standards, and test methods are classified and shown, and the related items are displayed in the form of hyperlinks.

At this time, it is preferable that the standard information includes standard annexes and guidelines for additional interpretation, and supports a shortcut menu corresponding to the guidelines through the information support module.

For example, if you look at the standard IEC 60601-1, there is a * mark in the standard title or item, and there is a * mark in the title in the attached figure 1 to 4.7. This means that there is an additional explanation in Annex A. In the actual standard, it is inconvenient to look back several hundred pages, but in the present invention, through the information support module 120, the corresponding page can be directly turned over with the Tab concept.

4 is an additional interpretation screen according to an embodiment of the present invention. As the standard is like a legal code, it is not described in a friendly way so that all contents can be easily understood. .

5 is a risk factor display screen according to an embodiment of the present invention.

As mentioned above, the text of the standard mainly explains the risk factors, test standards, and test methods. What to do means that if you do not do something, it can be dangerous, and what it is is related to the risk factor.

For example, in 4.7 ME EQUIPMENT SINGLE FAILURE CONDITIONS, there is a standard statement: "ME EQUIPMENT shall be designed and manufactured to ensure SINGLE FAULT SAFETY or risk is acceptable through the application of 4.2." Here, the risk factor becomes dangerous if not observed, so "securing single failure safety" or "application of Section 4.2" becomes a risk factor.

6 is a conceptual diagram of RMF creation according to an embodiment of the present invention.

As mentioned above, in the case where the standard presents a hazardous situation according to the hazardous factor and an acceptable test standard is prepared to prevent additional risk, the process of dealing with the hazardous factor in the most detail is the case in which the test method for the test standard is presented. is (4.2.3.1 a-1). However, in some cases, if the test method is simple enough to visually confirm whether or not it is valid, the test method may not be separately described (4.2.3.1 a-2).

In addition, acceptance criteria are not presented for some hazard factors. In this case, the manufacturer must present the acceptance criteria using the risk management process (4.2.3.1 b). The risk must be reduced in such a way that the manufacturer is asked to present the hazardous situation on its own and present appropriate risk control measures (4.2.3.1 c).

In addition, if the standard does not specify the risk factor field itself, risk reduction may be required in such a way that the risk that may occur with gamma ray is lowered on its own (4.2.3.2 RMF). For example, in terms of field, whichever of temperature, energy, instantaneous power, and frequency is a hazard is determined by the manufacturer, or in the case of X-ray, energy per unit mass (J/kg) is determined and managed as a hazard factor (1mSv, 50 mSv).

If it is a clinical hazard situation, if this field does not occur frequently or if it is a clinical hazard factor with contents corresponding to individual standards, it should be managed as essential performance (4.3), and non-clinical contents should be managed as functional safety.

In addition, in some cases, it is not necessary to follow the acceptance criteria or test methods presented in the standard, and if it is demonstrated that the manufacturer's new criteria or new method is similar or better than the criteria and methods presented in the standard, the standard can be ignored (4.5).

In other words, when the test (acceptance) standard is not presented in IEC 60601-1 or when the manufacturer sets the test standard (severity and possibility of occurrence of harm) through the risk management process without mentioning hazardous situations, the test standard is reasonable. After proving that the test standard is actually satisfied, risk management must be performed by the risk management process.

7 is a screen showing the TRF question screen according to an embodiment of the present invention by converting the contents of the TRF described in the standard as above into the form of a questionnaire below. The necessary information is provided in the form of a questionnaire so that researchers can easily apply the standard in the form of checking and answering the question.

The PRS creation module 140 presents whether or not the product under design corresponds to the risk factors in the form of a question, receives a selected answer, and creates product requirements based on the risk factor corresponding to the selected answer.

8 is a PRS generation screen according to an embodiment of the present invention. In order to create a PRS, it is provided in the form of a question whether the risk factor mentioned in the TRF corresponds to the device to be designed, and the researcher sees it and checks the answer if applicable. to support PRS creation. When an answer is selected, it is changed and confirmed, such as under bar.

The RMF creation module 130 includes a detailed confirmation unit 131 that checks whether hazardous situations related to hazard factors, acceptance criteria, and test methods are mentioned in the standard information, and unconfirmed hazardous situations, acceptance criteria, and test methods. A risk management file is created by providing a detailed input unit 132 for receiving test criteria and test methods.

9 is an RMF question screen according to an embodiment of the present invention, and FIG. 10 is an RMF input screen according to an embodiment of the present invention. After confirming whether the standard information mentions hazardous situations, acceptance criteria, and test methods related to hazard factors in the standard information through the detailed confirmation unit 131, if the hazardous situations, acceptance criteria, and test methods related to hazard factors are mentioned, there is a problem. However, as described in FIG. 6 attached above, in the case where risk management must be performed through a separate risk process and there is no mention of hazardous situations, acceptance criteria, and test methods related to hazard factors, detailed input unit 132 10 is provided through which test standards and test methods are input.

In the attached FIG. 10, a screen is shown so that clause 4.2 of ISO 14971 can be divided into four to be written in detail, and each time [Default Example] is pressed, several examples appear sequentially on the screen to support writing. At this time, examples may be made in advance through exemplary writing practices, or good samples may be presented among those written through the present invention.

The FRS creation module 150 classifies products under design by module, and creates functional requirements by applying the product requirements to each classified module. Examples of functional requirements are provided and creation according to the examples is provided. configured to support Likewise, examples may be made in advance through exemplary writing practices, and good samples may be presented among those written through the present invention.

11 is a FRS and V&V creation screen according to an embodiment of the present invention, and a screen for creating detailed functional requirements corresponding to the product appears as shown in FIG. 11 in the form of pressing [FRS hyperlink in the corresponding PRS.

Since FRS basically creates specifications for each module, you need to divide product modules through the module setting menu before writing, and you can write according to the order of the FRS writing examples provided, and even V&V plans can be created on this screen. there is.

The tracking module 160 assigns serial numbers to standard information, product requirements, and functional requirements related to the product under design, so that history management is performed. To implement the traceability to the aforementioned specifications, each requirement specification PRS number and FRS number are automatically assigned to the list so that you can easily understand the flow not only after writing but also during writing, and you can easily check related products, types of technical documents, module names, and contents according to module order.

The plan preparation module 170 receives basic information of a company, product, and person in charge, and prepares a design plan by arranging risk factors corresponding to the product requirements and functional requirements for each module.

12 is an initial information setting screen according to an embodiment of the present invention, which allows input of basic information necessary for a design plan, but based on this, PRS and FRS for each module are created, and as a document that collects them, the design plan and output is made.

The rights of the present invention are defined by what is described in the claims, not limited to the embodiments described above, and that those skilled in the art can make various modifications and adaptations within the scope of rights described in the claims. It is self-evident.

110: database 120: information support module
130: RMF creation module 131: detailed confirmation unit
132: detailed input unit 140: PRS creation module
150: FRS creation module 160: tracking module
170: plan writing module

Claims (5)

A database 110 storing standard information including standards and appendices containing risk factors, test standards and test methods;
An information support module 120 that provides browsing, search, and index functions of the standard information, but classifies and shows hazard factors, test standards, and test methods;
A PRS creation module 140 that presents whether or not the product under design corresponds to the above risk factors in the form of a question and receives a selected answer, but creates product requirements based on the risk factor corresponding to the selected answer;
An FRS creation module 150 for classifying products under design by module and creating functional requirements by applying the product requirements to each classified module;
A plan writing module 170 for receiving basic information of companies, products, and persons in charge, and preparing a design plan by arranging risk factors corresponding to the product requirements and functional requirements for each module; A device design support system comprising:
According to claim 1,
The standard information is
Includes standard annexes and guidelines for additional interpretation,
Device design support system characterized in that to support a shortcut menu corresponding to the guideline through the information support module.
According to claim 1,
In the standard information, enter the detailed confirmation unit 131 that checks whether or not the hazardous situation related to the hazard, acceptance criteria, and test methods are mentioned, and test criteria and test methods for unconfirmed hazardous situations, acceptance criteria, and test methods. An RMF creation module 130 for creating a risk management file with a detailed input unit 132 to receive; Device design support system further comprising a.
According to claim 1,
The FRS creation module 150,
A device design support system characterized in that it is configured to provide examples related to functional requirements and support creation according to the examples.
According to claim 1,
A tracking module (160) for performing history management by assigning serial numbers to standard information, product requirements, and functional requirements related to products under design; Device design support system further comprising a.