無(wú)源醫(yī)療器械設(shè)計(jì)開(kāi)發(fā)期間，設(shè)計(jì)驗(yàn)證是非常重要的一部分。做設(shè)計(jì)驗(yàn)證之前，首先問(wèn)自己一個(gè)問(wèn)題:為什么要做設(shè)計(jì)驗(yàn)證？

圖1 – 將設(shè)計(jì)控制應(yīng)用于瀑布設(shè)計(jì)過(guò)程

資料來(lái)源：FDA 《DESIGN CONTROL GUIDANCE FOR MEDICAL DEVICE MANUFACTURERS》（所用的圖得到加拿大衛(wèi)生部醫(yī)療器械局的許可）

1.什么是設(shè)計(jì)驗(yàn)證？

首先，我們要知道什么是設(shè)計(jì)驗(yàn)證：

設(shè)計(jì)驗(yàn)證：證實(shí)設(shè)計(jì)和開(kāi)發(fā)輸出滿足輸入的要求。即設(shè)計(jì)驗(yàn)證是在每個(gè)階段檢查輸出是否符合該階段要求的過(guò)程。

例如：設(shè)計(jì)輸入是否已被轉(zhuǎn)換為一種可以被充分驗(yàn)證的形式？器械實(shí)際尺寸是否與圖紙相符？產(chǎn)品包裝是否保護(hù)器械免受任何存儲(chǔ)和運(yùn)輸?shù)牟焕绊懀科餍凳欠衲褪芩x擇的滅菌方法？所選擇的滅菌方法是否能保證產(chǎn)品無(wú)菌？等等。

2. 設(shè)計(jì)驗(yàn)證的法規(guī)標(biāo)準(zhǔn)要求

其次，從法規(guī)標(biāo)準(zhǔn)的角度，看一下各國(guó)市場(chǎng)法規(guī)標(biāo)準(zhǔn)中對(duì)于設(shè)計(jì)驗(yàn)證要求的來(lái)源：

NMPA國(guó)內(nèi)市場(chǎng)

1.《GB/T 42061-2022 醫(yī)療器械 質(zhì)量管理體系用于法規(guī)的要求》

7.3.6設(shè)計(jì)和開(kāi)發(fā)驗(yàn)證

為確保設(shè)計(jì)和開(kāi)發(fā)輸出滿足設(shè)計(jì)和開(kāi)發(fā)輸入的要求，應(yīng)依據(jù)所策劃并形成文件的安排對(duì)設(shè)計(jì)和開(kāi)發(fā)進(jìn)行驗(yàn)證。

組織應(yīng)將驗(yàn)證計(jì)劃形成文件，驗(yàn)證計(jì)劃包括方法、接收準(zhǔn)則，適當(dāng)時(shí)包括包含樣本量原理的統(tǒng)計(jì)技術(shù)。

如果預(yù)期用途要求醫(yī)療器械連接至或通過(guò)接口連接至其他的一個(gè)或多個(gè)醫(yī)療器械，驗(yàn)證應(yīng)包括證實(shí)當(dāng)這樣連接或通過(guò)接口連接時(shí)設(shè)計(jì)輸出滿足設(shè)計(jì)輸入的要求。

應(yīng)保留驗(yàn)證結(jié)果和結(jié)論及必要措施的記錄（見(jiàn)4.2.4和4.2.5）

2.《醫(yī)療器械生產(chǎn)質(zhì)量管理規(guī)范》

第三十四條　企業(yè)應(yīng)當(dāng)對(duì)設(shè)計(jì)和開(kāi)發(fā)進(jìn)行驗(yàn)證，以確保設(shè)計(jì)和開(kāi)發(fā)輸出滿足輸入的要求，并保持驗(yàn)證結(jié)果和任何必要措施的記錄。

CE市場(chǎng)

1.《ISO 13485:2016》

7.3.6 Design and development verification

Design and development verification shall be performed in accordance with planned and documented arrangements to ensure that the design and development outputs have met the design and development input requirements.

The organization shall document verification plans that include methods, acceptance criteria and, as appropriate, statistical techniques with rationale for sample size.

If the intended use requires that the medical device be connected to, or have an interface with, other medical device(s), verification shall include confirmation that the design outputs meet design inputs when so connected or interfaced.

Records of the results and conclusions of the verification and necessary actions shall be maintained (see 4.2.4 and 4.2.5).

2. MDR REGULATION (EU) 2017/745

6. PRODUCT VERIFICATION AND VALIDATION 

The documentation shall contain the results and critical analyses of all verifications and validation tests and/or studies undertaken to demonstrate conformity of the device with the requirements of this Regulation and in particular the applicable general safety and performance requirements. 

(a)results of tests, such as engineering, laboratory, simulated use and animal tests, and evaluation of published literature applicable to the device, taking into account its intended purpose, or to similar devices, regarding the pre-clinical safety of the device and its conformity with the specifications;

(b) detailed information regarding test design, complete test or study protocols, methods of data analysis, in addition to data summaries and test conclusions regarding in particular

(c) the clinical evaluation report and its updates and the clinical evaluation plan referred to in Article 61(12) and Part A of Annex XIV;

(d)the PMCF plan and PMCF evaluation report referred to in Part B of Annex XIV or a justification why a PMCF is not applicable.

FDA市場(chǎng)

《QSR 820.30》

(f) Design verification. Each manufacturer shall establish and maintain procedures for verifying the device design . Design verification shall confirm that the design output meets the design input requirements.  The results of the design verification, including identification of the design, method(s), the date, and the individual(s) performing the verification , shall be documented in the DHF.

《QSR 820.250》 

(a) Where appropriate, each manufacturer shall establish and maintain procedures for identifying valid statistical techniques required for establishing, controlling, and verifying the acceptability of process capability and product characteristics .

(b) Sampling plans, when used, shall be written and based on a valid statistical rationale. Each manufacturer shall establish and maintain procedures to ensure that sampling methods are adequate for their intended use and to ensure that when changes occur the sampling plans are reviewed. These activities shall be documented. 

3. 設(shè)計(jì)驗(yàn)證的目的

設(shè)計(jì)驗(yàn)證的目的是提供客觀證據(jù)以證明你的設(shè)計(jì)要求已經(jīng)滿足，如果設(shè)計(jì)要求沒(méi)有滿足，則需要表明設(shè)計(jì)離達(dá)到要求還有多遠(yuǎn)。設(shè)計(jì)驗(yàn)證確保在進(jìn)入設(shè)計(jì)確認(rèn)之前是經(jīng)過(guò)驗(yàn)證的設(shè)計(jì)。

4. 設(shè)計(jì)驗(yàn)證的重要性

在設(shè)計(jì)開(kāi)發(fā)過(guò)程的早期（如定義設(shè)計(jì)輸入時(shí)）就應(yīng)該考慮設(shè)計(jì)驗(yàn)證。

設(shè)計(jì)驗(yàn)證是所有注冊(cè)申報(bào)的一個(gè)重要因素，監(jiān)管機(jī)構(gòu)將尋找客觀證據(jù)，以判定你的醫(yī)療器械符合安全性和有效性的基本要求。