@neobiotechlabs/neobiotech-dev-agent 0.1.7

package/vendor/dev-docs-templates/templates/mdr_docs/CA/usability-evaluation-report.md

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+# Usability Evaluation Report
+
+The Usability Evaluation report describes the results of all (formative and summative) Usability Evaluations.
+
+## Mapping of Standard Requirements to Document Sections
+
+| IEC 62366-1:2015 Section | Title                                             | Document Section |
+|--------------------------|---------------------------------------------------|------------------|
+| 4.1.3                    | Information for Safety as it relates to Usability | 4.5              |
+| 4.2                      | Usability Engineering File                        | (all)            |
+
+## 1. Relevant Processes
+
+Usability Engineering and Evaluation activities are defined in the **SOP Integrated Software Development**.
+
+## 2. Related Documents
+
+ * List of Hazard-Related Use Scenarios
+ * Usability Evaluation Protocol
+ * Usability Evaluation Plan
+
+## 3. Summary of Formative Evaluations
+
+### 3.1 Formative Evaluation 1
+
+## 4. Summary of Summative Evaluation
+
+## 4.1 Methods
+
+> Copy-paste this section from the Usability Evaluation Plan (5.2 Planning (Setting)).
+
+### 4.2 Overview over Tests
+
+> Copy-paste this table from the Usability Evaluation Protocol.
+
+| ID | Description | App State / Environment | Instructions | Acceptance Criteria | Observations | Hazards encountered |
+|----|-------------|-------------------------|--------------|---------------------|--------------|---------------------|
+|    |             |                         |              |                     |              |                     |
+
+### 4.3 Pass / Fail Counts of Tests
+
+> Count the pass/fail results from the Usability Evaluation Protocol
+
+| Test ID | Description | Total Count | Pass Count | Fail Count |
+|---------|-------------|-------------|------------|------------|
+|         |             |             |            |            |
+
+### 4.4 Use Errors and Hazards
+
+| Test ID | Description | Use Error | Potential Hazard |
+|---------|-------------|-----------|------------------|
+|         |             |           |                  |
+
+### 4.5 Information for Safety
+
+> Describe whether information for safety could correctly be perceived and understood by the users and
+> whether it supported the correct use of the medical device.
+
+### 4.6 Other Findings
+
+## 5. Qualitative Participant Feedback
+
+## 6. Conclusion
+
+---
+
+Template Copyright [openregulatory.com](https://openregulatory.com). See [template
+license](https://openregulatory.com/template-license).
+
+Please don't remove this notice even if you've modified contents of this template.

package/vendor/dev-docs-templates/templates/mdr_docs/EA/clinical-evaluation-plan.md

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+# Clinical Evaluation Plan
+
+The Clinical Evaluation Plan defines methods for creating and updating the Clinical Evaluation Report. This
+plan is updated later by the post-market clinical follow-up, e.g., to include new search criteria for the
+literature search.
+
+> While the content of the Clinical Evaluation is simple, writing it, coming up with the right structure and
+> forming a sensible line of reasoning (equivalence) can be a bit tricky.
+>
+> These are the guidance documents on Clinical Evaluation. If you're the person writing it, you should read
+> them:
+>
+> * Regulation (EU) on Medical Devices 2017/745
+> * MEDDEV 2.7/1 "CLINICAL EVALUATION"
+> * MDCG 2020-1 Guidance on Clinical Evaluation & Performance Evaluation of Medical Device Software
+> * MDCG 2020-5 Guidance on Clinical Evaluation – Equivalence
+> * MDCG 2020-6 Guidance on Sufficient Clinical Evidence for Legacy Devices
+> * MDCG 2020-13 Clinical Evaluation Assessment Report Template
+> * GHTF 2006 Clinical Evaluation
+>
+> The following checklist provides an overview of possible documents and information that may be relevant for
+> the clinical evaluation.
+>
+> * Intended use
+> * Product description (indications/ contraindications)
+> * Instructions for use
+> * List of potential equivalent products (competitors, predecessor model)
+> * Instructions for use/marketing brochures of the competitor or predecessor model
+> * Comparison of the equivalent products
+> * Information on possible alternative treatment methods
+> * List of marketing claims that are advertised (especially clinical claims)
+> * Marketing brochures
+> * Risk management files (plan, analysis and report), annual risk management reports
+> * Usability file/ user studies
+> * PMS/PMCF plan
+> * PMS report/ PSUR
+> * Sales figures of the product or predecessor product (incl. details of the period)
+> * Complaint handling; number of safety-related incidents reported (incl. details of the time period)
+> * Reports on clinical studies/clinical trials conducted
+> * Relevant preclinical studies or test reports that support safety and performance
+> * Checklist of general safety and performance requirements
+> * Previous clinical evaluation of the product or predecessor model
+> * List of relevant literature or guidelines
+> * Software tests
+
+## 1. Purpose and Scope
+
+According to the Regulation (EU) 2017/745, Article 61 and ANNEX XIV, the evaluation of the clinical
+performance and safety as well as the clinical benefit must be based on 'clinical data' and is required for
+all medical device classes. The clinical evaluation report and the clinical data on which it is based,
+verifies the clinical safety and performance of the \<device name\>. This clinical evaluation plan outlines the
+scope of the clinical evaluation.
+
+## 2. Definitions
+
+| Definition / Abbrevitation | Description              |
+|---------------------------|--------------------------|
+| MDR                       | Regulation (EU) 2017/745 |
+| [...]                     | [...]                    |
+
+## 3. Product Information
+
+|                 |   |
+|-----------------|---|
+| Manufacturer:   |   |
+| Product name:   |   |
+| Product models: |   |
+| CE marking:     |   |
+| Classification: |   |
+
+Further information regarding the device (e.g. intended user group, indications, contraindications can be
+found in the document ISD - Intended Use (provide a reference).
+
+## 4. Clinical Benefits
+
+Describe the intended clinical benefit(s) of the device.
+
+The clinical evaluation report compares the recognized benefits of the device with its associated risks,
+facilitating a comprehensive benefit-risk assessment.
+
+## 5. Clinical Claims
+
+All claims related to the \<medical device\> can be found in the table below. These claims will be thoroughly
+examined as part of the literature search in the clinical evaluation.
+
+| No. | Claim                                       | Source                            | Reference                                                                                                                              |
+|-----|---------------------------------------------|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|
+| 1   | \<Our device reduces procedure time by 20%\> | \<Website / promotional material\> | \<Usability study / Literature analysis (addressed in clinical evaluation report) / verification and validation / PMS data; PMCF data\> |
+| ... |                                             |                                   |                                                                                                                                        |
+
+If there are no claims:
+No claims require validation through the clinical evaluation
+
+## 6. Risk Management
+
+A risk analysis, conducted in compliance with EN ISO 14971 for the \<medical device\>, is currently documented
+in:
+
+* SOP Risk management
+* Risk Management Plan
+* Risk Analysis
+* Risk Management Report
+
+The risk management plan/process of the medical device outlines the methodologies employed to scrutinize both
+qualitative and quantitative aspects of clinical safety. The analysis of clinical data will encompass all
+residual risks and side-effects. Additionally, any hazards, risks, and side-effects identified in the clinical
+evaluation report will undergo evaluation in the risk management file. The device's risks will be assessed
+against its identified benefits to conduct a comprehensive benefit-risk assessment.
+
+## 7. Clinical Development Plan
+
+> Provide a brief overview of all the clinical investigations that have either been performed, are ongoing, or
+> are planned in the near future.
+>
+> If you have no studies: For the device we did not conduct clinical studies. Describe your justification.
+
+## 8. Clinical Evidence
+
+Clinical evaluation is an on-going process, conducted throughout the life cycle of a MDSW. Both favorable and
+unfavorable data considered in the clinical evaluation shall be included in the technical documentation.
+
+Three key components will be taken into account when compiling clinical evidence:
+
+**Valid clinical association**
+
+Demonstrate that it corresponds to the clinical situation, condition, indication or parameter defined in the
+intended purpose of the MDSW
+
+**Technical performance**
+
+Demonstration of the MDSW’s ability to accurately, reliably and precisely generate the intended output, from
+the input data.
+
+**Clinical performance**
+Demonstration of a MDSW’s ability to yield clinically relevant output in accordance with the intended purpose
+
+## 9. Post-market surveillance
+
+The following databases will be searched:
+
+* MHRA (Medicines and Healthcare products Regulatory Agency)
+* Swissmedic
+* BfArM (Bundesinstitut für Arzneimittel und Medizinprodukte)
+* FDA database MAUDE
+* FDA database for recalls
+
+In addition, a PMCF plan is in place according to MDR, Annex XIV Part B.
+
+---
+
+Template Copyright [openregulatory.com](https://openregulatory.com). See [template
+license](https://openregulatory.com/template-license).
+
+Please don't remove this notice even if you've modified contents of this template.

package/vendor/dev-docs-templates/templates/mdr_docs/EA/list-of-hazard-related-use-scenarios.md

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+# List of Hazard-Related Use Scenarios
+
+## Mapping of Standard Requirements to Document Sections
+
+| IEC 62366-1:2015 Section | Title                                                            | Document Section |
+|--------------------------|------------------------------------------------------------------|------------------|
+| 5.4                      | Identify and describe Hazard-Related Use Scenarios               | 1                |
+| 5.5                      | Select the Hazard-Related Use Scenarios for Summative Evaluation | 1                |
+
+## Summary
+
+The goal of the list of Hazard-Related Use Scenarios is to gather all Use Scenarios which could be associated
+with a Hazard, e.g., if a user doesn't understand a certain feature of the app (bad design leading to poor
+usability), then a Hazard could be encountered which could subsequently lead to a Hazardous Situation.
+
+## 1. Hazard-Related Use Scenarios
+
+> Fill out this list with Use Scenarios which could be Hazard-related. A good rule of thumb is to have 3-10
+> scenarios, based on the risk profile of your software.
+>
+> Also, note that you should prefer to create a spreadsheet for this table (e.g., in Google Sheets) as putting a
+> table in a document will surely lead to chaos. But then again, there's always a certain level of chaos in
+> regulatory documentation.
+
+| ID | User Group | Description        | App State / Environment                               | Tasks                                                         | Acceptance Criteria                 |
+|----|------------|--------------------|-------------------------------------------------------|---------------------------------------------------------------|-------------------------------------|
+| 1  | Physician  | Assess COVID score | 1) App is installed<br>2) App displays patient result | Understand COVID score and initiate further medical treatment | COVID score is understood correctly |
+
+---
+
+Template Copyright [openregulatory.com](https://openregulatory.com). See [template
+license](https://openregulatory.com/template-license).
+
+Please don't remove this notice even if you've modified contents of this template.

package/vendor/dev-docs-templates/templates/mdr_docs/EA/risk-table-fmea.md

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+# Failure Mode and Effects Analysis (FMEA): Risk Table
+
+<!-- AI AGENT 작성 지침
+이 문서는 ISO 14971:2019 기반 위험 분석 테이블입니다. EA 단계 초안을 작성하고, ER 단계 Sprint마다 업데이트합니다.
+
+작성 전 반드시 다음 문서를 참조하세요:
+  - 사용 목적 정의서(intended-use.md): 의도된 사용자, 사용 환경, 의료 목적 확인
+  - 위험 관리 계획서(risk-management-plan.md): 위험 허용 기준 매트릭스(P1~P5, S1~S4) 확인
+  - SW 요구사항 명세서(software-requirements-list.md): SRS-S-xxx 보안 요구사항 확인
+
+작성 지침:
+1. 위험 ID 체계: HA-xxx (Hazard Analysis), FM-xxx (Failure Mode), RC-xxx (Risk Control)
+2. 다음 3가지 위험 카테고리를 반드시 포함하세요:
+   a) SW 오동작으로 인한 위험 (IEC 62304 Cl.7.1)
+   b) 사용 오류로 인한 위험 (IEC 62366-1)
+   c) 사이버보안 위협으로 인한 위험 (IEC 81001-5-1, MDR Annex I 17.2)
+3. 확률(P) 및 중증도(S) 등급은 RMP의 매트릭스 기준을 사용하세요
+4. 위험 통제 조치 적용 후 잔여 위험(Residual Risk)의 허용 여부를 반드시 명시하세요
+5. 위험 통제 조치(RC)는 SRS에 반영 후 "위험 통제 조치? = Yes"로 연결하세요
+
+위험 ID 예시:
+  HA-001: 초기 위험 식별 (PHA)
+  FM-001: 소프트웨어 고장 모드
+  RC-001: 위험 통제 조치
+-->
+
+
+| ISO 14971:2019 Section | Document Section                                   |
+| ---------------------- | -------------------------------------------------- |
+| 5.2                    | (all; entries about reasonably foreseeable misuse) |
+| 5.4                    | 3                                                  |
+| 5.5                    | 3, 4                                               |
+| 6                      | 3                                                  |
+| 7.1                    | 4                                                  |
+| 7.2                    | 4                                                  |
+| 7.3                    | 4                                                  |
+| 7.5                    | 4                                                  |
+
+| IEC 62366-1:2015 Section | Title                                                          | Document Section |
+| ------------------------ | -------------------------------------------------------------- | ---------------- |
+| 4.1.2                    | Risk Control as it relates to User Interface design            | 4                |
+| 5.3                      | Identify known or foreseeable Hazards and Hazardous Situations | 1,3              |
+
+This is a Failure Mode and Effects Analysis ([FMEA][wikipedia-fmea]) of the device. It is separated into
+multiple sections:
+
+ * **Failure Modes** lists everything which can go wrong
+ * **Hazards and Analysis** lists everything (harms) which can subsequently happen, including an analysis of
+   probability and severity
+ * The list of **Risk Control Measures** contains all control measures which were implemented for risk
+   reduction, either reducing probability or severity, or both.
+
+> Ugh, this became more complex than I initially expected. I am so sorry. From a teaching perspective, it's
+> actually simpler to explain if I throw everything into one table. Instead, we have three here now, because I
+> can't trivially upload spreadsheets to the website, so I had to reduce the column count to make them
+> fit. Painful. I'll try to explain as we go along.
+
+## 1. Preliminary Hazards Analysis (PHA)
+
+> A Preliminary Hazards Analysis (PHA) is simply a list of stuff which can go wrong. Typically, you come up
+> with that stuff when you think about your product. Like, when you do Covid predictions, you come up with the
+> thought that a wrong prediction will result in a bad outcome. Makes sense. So, here's a table in which you
+> can collect those ideas. Besides the description it also has the column "source" which describes where the
+> idea came from (typical options are: Intended Use, User Test, 14971 checklist (there is one in the 2012
+> version, otherwise there's TR 24971, I think)) and "Hazard ID(s)" which shows where you've continued the
+> analysis (including probability and severity) of that risk. It refers to the ID(s) in the Hazards and
+> Analysis table below.
+
+| ID  | Source                 | Description                           | Hazard ID(s) |
+| --- | ---------------------- | ------------------------------------- | ------------ |
+| 1   | General Considerations | Wrong Covid Prediction                | 1            |
+| 2   | Intended Use           | Wrong Covid Prediction                | 1            |
+| 3   | Usability Test         | User misunderstands prediction result | 1            |
+
+
+## 2. Failure Modes
+
+> This is a list of stuff which can go wrong in your software. You should be able to come up with things while
+> you write code and when you think about it. Typically, stuff which always can go wrong is 1) something
+> becomes unavailable, 2) something returns invalid data, 3) something gets hacked.
+
+> I've written some examples for the Covid predictor application which I cover in my videos - you don't have
+> to watch those for now. The idea is that it's an app which predicts whether a certain patient has Covid,
+> pretty magical. An obvious failure mode would be that the app either calculates wrong predictions on the
+> backend (ID 1), or the frontend displays the predictions wrongly (ID 2). They both lead to the same hazard
+> (ID 1) which is listed in the Hazards and Analysis table below.
+
+| ID  | Software System | Failure Mode                       | Hazard ID(s) |
+| --- | --------------- | ---------------------------------- | ------------ |
+| 1   | Backend         | Wrong Covid Prediction             | 1            |
+| 2   | Frontend        | Covid Prediction displayed wrongly | 1            |
+
+## 3. Hazards and Analysis
+
+> This is a list of stuff which will subsequently happen after your software has failed. It's more about what
+> happens in the real world, not in your software. The 14971 wants you to analyze Hazards, Hazardous
+> Situations and Harms, so that's what you'll find in the table :)
+>
+> Here's what happens: In the beginning, there's a hazard, like a wrong Covid prediction. That hazard has a
+> certain probability to lead to the (next) hazardous situation, in this case 1% (0.01), in which the user
+> thinks he is healthy, but actually has Covid. You can estimate p1 with some medical knowledge, in this case
+> maybe the prevalence of Covid in your target population.
+>
+> Then, this hazardous situation may lead to a harm, in this case, disease progression - the user who got the
+> wrong Covid prediction (healthy) may actually have Covid and now stay at home instead of going to the
+> hospital. So the disease gets worse. Maybe only 10% (0.1, p2) of users will actually blindly trust my Covid
+> app - so not all of them will get disease progression. Again, estimate this based on your own data.
+>
+> Finally, you multiple p1 with p2, check your Risk Acceptance Matrix (see template for the risk management plan) which Probability
+> Category it is (in this case P4). Also check that matrix which severity that harm would be, I'm just
+> assuming it could be S2 here. Once you have your Probability (P) and Severity (S), check your matrix whether
+> that's acceptable. In this case, it's not.
+>
+> So we need a Risk Control Measure which is referenced here by ID (1). As we can see, it reduced the
+> probability to P3, but not the severity. But that's fine, because the P3 and S2 - combination is acceptable,
+> based on our Risk Acceptance Table.
+>
+> The next table contains the list of Risk Control Measures.
+
+| ID  | Hazard                 | p1   | Hazardous Situation                      | p2  | Harm                | p1*p2 | P   | S   | Acceptable? | Comment | Risk Control ID(s) | P   | S   | Acceptable? |
+| --- | ---------------------- | ---- | ---------------------------------------- | --- | ------------------- | ----- | --- | --- | ----------- | ------- | ------------------ | --- | --- | ----------- |
+| 1   | Wrong Covid prediction | 0.01 | User thinks he is healthy, but has Covid | 0.1 | Disease progression | 0.001 | P4  | S2  | No          |         | 1                  | P3  | S2  | Yes         |
+
+## 4. Risk Control Measures
+
+> This is the table of Risk Control Measures which was referenced from the Hazards and Analysis table
+> above. We've used the Risk Control Measure with (ID 1) to reduce the risk of disease progression. For that,
+> we came up with a procedure to check our prediction algorithm with test data before we ship it. That makes
+> sense and that should probably reduce the probability of wrong predictions. In this case, by 0.01 (10^-2,
+> I'm coming up with numbers here). It doesn't reduce the severity, of course - the harm is still disease
+> progression.
+
+> Note that the 14971 has three types of Risk Control Measures:
+> * Inherent Safety by Design
+> * Protective Measures
+> * Information for Safety
+>
+> Also note that, in simplified terms, Information for Safety must actually be displayed in your application
+> to have any effect. Like, not in the user manual, because nobody reads the manual.
+
+| ID  | Description                               | Type               | Probability Reduction | Severity Reduction | Negative Influence on Device Safety / Performance Introduced by Mitigation Measure? | Verification Implementation | Verification Effectiveness |
+| --- | ----------------------------------------- | ------------------ | --------------------- | ------------------ | ----------------------------------------------------------------------------------- | --------------------------- | -------------------------- |
+| 1   | Check prediction algorithm with test data | Protective Measure | 10^-2                 | 1                  | No                                                                                  | Link Software Test ID       | Link Usability Test ID     |
+
+---
+
+Template Copyright [openregulatory.com](https://openregulatory.com). See [template
+license](https://openregulatory.com/template-license).
+
+Please don't remove this notice even if you've modified contents of this template.
+
+
+<!-- Links -->
+
+[wikipedia-fmea]: https://en.wikipedia.org/wiki/Failure_mode_and_effects_analysis