@neobiotechlabs/neobiotech-dev-agent 0.1.7

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

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+# Clinical Evaluation Report
+
+## 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].
+
+A clinical evaluation plan [Reference] is in place and this clinical evaluation report is carried out in
+accordance with the plan.
+
+## 2. Definitions
+
+| Definition / Abbreviation | Description              |
+|---------------------------|--------------------------|
+| MDR                       | Regulation (EU) 2017/745 |
+| [...]                     | [...]                    |
+
+## 3. Product Information
+
+|                 |   |
+|-----------------|---|
+| Manufacturer:   |   |
+| Product name:   |   |
+| Product models: |   |
+| CE marking:     |   |
+| Classification: |   |
+
+### 3.1 Intended Use
+
+> Add intended use.
+
+### 3.2 Patient Population
+
+> Add patient population
+
+### 3.3 Intended Medical Indication
+
+> Add intended medical indication
+
+### 3.4 Contraindications
+
+> If none, state as follows: There are no known specific situations that contraindicate the use of this device.
+
+### 3.5 Operating Principle
+
+> Offer a detailed overview of the device, encompassing its name, models, sizes, and components across
+> hardware, software, and accessories. Clearly categorize the device, such as a biological artificial aortic
+> valve, and outline its physical and chemical attributes, technical specifications, and mechanical
+> traits. Specify sterilization methods, radioactivity considerations, and operational principles. Detail
+> materials used, particularly those in contact with the patient, and any inclusion of medicinal substances,
+> animal tissues, or blood components. Incorporate a visual representation, and note the device's class,
+> global market entry, and specific product configurations. Highlight innovative features relevant to ongoing
+> assessments and address unmet medical needs. Provide concise step-by-step application procedures, elucidate
+> performance in different modes, and describe the device's workflow.
+
+### 3.6 User Profile
+
+> Describe the typical user of the software. Some ideas could be: Qualifications, prior training (for your
+> software), technical proficiency, time spent using the software.
+
+### 3.7 User Environment Including Hardware / Software
+
+> Describe the typical use environment. What sort of devices is this running on? Does the software only run on
+> one device or multiple devices? Is it loud and chaotic like in an emergency ward? How’s the lighting? Also,
+> add other software or hardware which is required by your device. Most commonly, apps require users to have a
+> smartphone with a compatible operating system (iOS / Android).
+
+## 4. Clinical Benefits
+
+> Describe the intended clinical benefit(s) of the device.
+
+## 5. Clinical Claims
+
+All claims 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. Context of the Medical Device
+
+### 6.1 Developmental Context
+
+> Provide an overview of the device's developmental context, including its current market presence in Europe
+> or other countries, the duration of its presence, and the quantity of devices placed on the market. Consider
+> incorporating information from relevant publications to enrich this chapter.
+
+### 6.2 State of the Art
+
+> Outline the state of the art and the medical alternatives of the device. Summarise guidance documents,
+> common specifications or health technology assessment report, which could help describing the state of the
+> art. Usually, review articles provide a broad overview on the state of the art and medical alternatives.
+
+## 7. 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
+
+### 7.1 Valid Clinical Association
+
+Valid clinical association is understood as the extent to which, the MDSW’s output (e.g. concept, conclusion,
+calculations) based on the inputs and algorithms selected, is associated with the targeted physiological state
+or clinical condition. This association should be well founded or clinically accepted. The valid clinical
+association of a MDSW should demonstrate that it corresponds to the clinical situation, condition, indication
+or parameter defined in the intended purpose of the MDSW.
+
+> Example: MDSW that detects heart arrhythmia by analysing auscultation sound obtained by a digital
+> stethoscope requires demonstrating valid clinical association of the association between abnormal cardiac
+> sounds and heart arrhythmia. Evidence supporting valid clinical association can be generated e.g. through
+> literature research, professional guidelines, proof of concept studies, or manufacturer’s own clinical
+> investigations/clinical performance studies.
+>
+> The is intended to […]. This is a well-established clinical procedure and clinically accepted.
+> The valid clinical association will be demonstrated with:
+>
+> * Technical standards
+> * Professional medical society guidelines
+> * Systematic scientific literature review
+> * Clinical investigations
+> * Published clinical data (e.g. Summary of Safety and Clinical Performance (SSCP) / Summary of Safety and
+>   Performance (SSP), Registries and databases from authorities)
+
+
+#### 7.1.1 Systematic scientific literature review
+
+Chosen source for the literature search is PubMed. The table lists the search terms used and the number of
+results.
+
+| No. | Search category                         | Search term | no. of results |
+|-----|-----------------------------------------|-------------|----------------|
+| 1   | Clinical association / state of the art |             |                |
+| ... |                                         |             |                |
+
+> Describe the total number of results and the number of duplicate publications.
+
+Different filters, exclusion & selection criteria have been used.
+
+> Justify the set filters, especially the timeframe and the limitation of certain evidence level.
+
+**Filter**
+
+* Publication Dates
+* Article types
+* Languages
+* Species
+* Text availability
+
+**Exclusion criteria**
+
+* Publications about animal trials
+* Publications in a language other than English
+* Publications published before [Date]
+* Publications with no abstract
+* Duplicates identified in more than one search category
+* Publications with the following content are generally not relevant:
+* ...
+
+**Selection criteria**
+
+* Publications describing or focusing on the use of the medical device under evaluation
+* Publications describing the use of an equivalent device
+* Publications describing or focusing on comparative literature of medical alternatives and state of the art
+  of the medical device under evaluation
+* …
+
+### 7.2 Technical Performance
+
+> According to the MDCG 2020-1 technical performance is the demonstration of the MDSW’s ability to accurately,
+> reliably and precisely generate the intended output, from the input data. Evidence supporting technical
+> performance can be generated through verification and validation activities, e.g. unit-level, integration,
+> and system testing or by generating new evidence through use of curated databases, curated registries,
+> reference databases or use of previously collected patient data.
+>
+> Technical performance is confirmed by the examination and provision of objective evidence that the MDSW
+> specifications conform to user needs and intended uses, and that the requirements implemented can be
+> consistently fulfilled. For example, performance verification and validation in the intended computing and
+> use environments can be characterized by the demonstration of:
+>
+> * availability,
+> * confidentiality,
+> * integrity,
+> * reliability,
+> * accuracy (resulting from trueness and precision),
+> * analytical sensitivity,
+> * limit of detection,
+> * limit of quantitation,
+> * analytical specificity,
+> * linearity,
+> * cut-off value(s),
+> * measuring interval (range),
+> * GENERALISABILITY,
+> * expected data rate or quality,
+> * absence of inacceptable cybersecurity vulnerabilities,
+> * HUMAN FACTORS ENGINEERING.
+>
+> Summarize the relevant tests, validations and verifications to demonstrate that the medical deviceaccurately
+> and consistently meets the intended purpose in real-world usage. Add subchapter if necessary.
+
+### 7.3 Clinical performance
+
+> Validation of the CLINICAL PERFORMANCE is the demonstration of a MDSW’s ability to yield clinically relevant
+> output in accordance with the intended purpose. The clinical relevance of a MDSW’s output is a positive
+> impact on the health of an individual expressed in terms of measurable, patient-relevant clinical
+> outcome(s), including outcome(s) related to diagnosis, prediction of risk, prediction of treatment
+> response(s), or related to its function, such as that of screening, monitoring, diagnosis or aid to
+> diagnosis of patients, oron patient management or public health. Example for clinical performance is a
+> retrospective study on previously obtained data. Generate evidence that shows your:SaMD has been tested in
+> your target population and for your intended use; and that users can achieve clinically meaningful outcomes
+> through predictable and reliable use.
+>
+> Note that line with the provisions of MDR Article 61 (1), the level of clinical evidence required should be
+> appropriate in view of the device claims and characteristics. For medical devices, where the demonstration
+> of conformity with GSPRs based on clinical data is not deemed appropriate (MDR Article 61 (10)), the
+> manufacturer shall duly substantiate in the technical documentation why it is adequate to demonstrate
+> conformity based on the results of non-clinical testing methods alone, bench testing and preclinical
+> evaluation, and usability assessment.
+>
+> This means in case where your device does not produce clinical data, you can use bench testing and usability
+> to demonstrate the clinical performance.
+>
+> Summarize the clinical performance data.
+
+#### 7.3.1 Equivalent device
+
+> If no equivalence is claimed: No equivalent device could be identified.
+>
+> General guidance including a detailed comparison table is provided in the MDCG 2020-05. Read this guidance
+> and use the table to demonstrate equivalence if applicable.
+
+## 8 Risk Management
+
+A risk analysis, conducted in compliance with EN ISO 14971 is currently documented in the:
+
+* SOP Risk management
+* Risk Management Plan
+* Risk Analysis
+* Risk Management Report
+
+### 8.1 Known Hazards and Risks
+
+> List hazards/ risks associated with the medical device.
+
+### 8.2 Known Side-Effects
+
+> If applicable, please list/ describe side-effects.
+
+### 8.3 Precautions and Warnings
+
+> List precautions and warnings.
+
+### 8.4 Usability Engineering
+
+> Please provide a summary of the usability engineering either deriving from separate documents or the risk
+> management.
+>
+> Example of text of the conclusion might be:
+>
+> The evaluation of the usability in accordance with IEC 62366-1 confirms that the design adequately reduces
+> the risk of use error as far as possible, that the design is adequate for the intended users and that the
+> information materials supplied by the manufacturer for the intended users are suitable.
+
+### 8.5 Additional risks identified in the literature
+
+PubMed has been searched for risks that might be associated with the use of the medical device.
+
+> Describe here the search for risks and usability related risks with the use of the device. State the filters
+> used in your search.
+
+| Risks                            | Search term | No. of results |
+|----------------------------------|-------------|----------------|
+| Risks associated with the device | Search term |                |
+
+> Describe the total number of results and the number of duplicate publications.
+
+| Usability related risks          | Search term | No. of results |
+|----------------------------------|-------------|----------------|
+| Risks associated with the device | Search term |                |
+
+> Describe the total number of results and the number of duplicate publications.
+
+> List the publications in Annex Literature accordingly.
+
+> Summary of identified risks
+>
+> A general patient benefit has been identified and proven within the literature. However, some possible
+> complications have been reported in the literature.
+>
+> Limit your focus to risks that are directly or indirectly linked to the medical device. Risks related solely
+> to the procedure, without any interaction with the medical device under evaluation, are not pertinent to
+> this chapter or the risk-benefit assessment.
+
+| Literature ref. | Risks / Complications | Considered in risk management? |
+|-----------------|-----------------------|--------------------------------|
+| ...             | ...                   | ...                            |
+
+* Not one of the outlined risks pertained to an overarching product issue or design flaw. The examination of
+  pertinent publications did not unveil any apprehensions concerning the safety. Additionally, the literature
+  review did not uncover any risks that haven't already been addressed in the existing risk management
+  protocols.
+* Summarise the literature regarding usability.
+* In the absence of usability information: A review of the literature did not uncover any additional insights
+  regarding the usability aspects associated with the use of the . Furthermore, there is no indication in the
+  literature of any overarching product issues or design flaws related to usability.
+
+### 8.6 Conclusion of Risk Management
+
+> Example of text might be:
+>
+> Risk control measures were established and executed in accordance with the Risk Management Plan. These
+> implemented measures are predominantly aligned with the adherence to relevant standards. Furthermore,
+> technical control and monitoring measures were introduced and successfully validated for efficacy. The risk
+> management process validates the adequacy of information materials provided by the manufacturer, ensuring
+> that risk mitigation measures are accurately addressed in the Instructions for Use (IFU). Following the
+> successful implementation of these risk control measures, both the remaining individual risks and the
+> overall residual risks were evaluated as acceptable [Reference the Risk Management Report].
+
+## 9 Post-Market Surveillance Data
+
+> Present available post-market surveillance data and delineate its significance in assessing the clinical
+> performance and safety of the relevant medical device. If applicable, reference post-market surveillance
+> reports or periodic safety update reports, focusing on conclusions that are relevant to the device's
+> clinical performance and safety.
+>
+> [Manufacturer] has implemented a post-market surveillance (PMS) system to promptly identify new risks not
+> previously recognized during the extended market experience. This commitment ensures the immediate execution
+> of corrective and preventive actions, as detailed in <reference to the post-market surveillance system.
+>
+> This section further consolidates insights gained from the medical device under evaluation and/or its
+> equivalent devices, utilizing internal and external databases. The strategy for identifying pertinent
+> reports is tailored to each database.
+>
+> Add or remove subchapters as needed. If possible, align the timeframe for database searches with that of the
+> literature search. If an excessive number of potentially relevant results arise, opt for a restricted
+> timeframe with justification.
+
+### 9.1 Internal Vigilance System
+
+> Summarise the data regarding sales numbers and complaints.
+
+### 9.2 Additional Post-Market Clinical Follow-Up Data
+
+> PMCF is planned and conducted to proactively collect and evaluate clinical data with the aim of confirming
+> the clinical safety and performance throughout the expected lifetime of the device, ensuring the continued
+> acceptability of identified risks and detecting emerging risks on the basis of factual evidence.
+>
+> Summarise the data regarding PMCF of the device under evaluation & reference the post-market clinical
+> follow-up plan.
+
+### 9.3 Relevant Device Registers
+
+> Please summarise internal and external register data.
+>
+> If no internal device register is available, example of text might be:
+>
+> The manufacturer has not implemented an internal device register.
+
+### 9.4 BfArM Database
+
+Sources:
+https://www.bfarm.de/SiteGlobals/Forms/Suche/EN/Expertensuche\_Formular.html?nn=708434&cl2Categories\_Format=kundeninfo
+
+The following search terms have been used:
+
+Please state a timeframe of the search if restricted.
+The search led to \<xxx\> results of which only \<xx\> refer to the or its equivalent devices.
+
+| Ref. | Issue Date | Device | Description / Action | Relevant? |
+|------|------------|--------|----------------------|-----------|
+|      |            |        |                      |           |
+
+### 9.5 Swissmedic Database if applicable
+
+> Summarize the search in this database and use the structure provided in the BfArm example.
+
+### 9.6 MHRA Database if applicable
+
+> Summarize the search in this database and use the structure provided in the BfArm example.
+
+### 9.7 FDA MAUDE Database if applicable
+
+> Summarize the search in this database and use the structure provided in the BfArm example.
+
+### 9.8 FDA Recall Database if applicable
+
+> Summarize the search in this database and use the structure provided in the BfArm example.
+
+### 9.9 Summary and Conclusion of PMS Data
+
+> Offer a condensed overview of post-market surveillance data, incorporating considerations on risk management and usability. Enumerate identified risks aligned with the evaluation, ensuring comprehensive coverage of all risk management aspects. Specifically, focus on assessing use errors and the design of the user interface. Include details about the user profile and usage environment, if applicable.
+>
+> Noteworthy complications from MHRA, Swissmedic, BfArM, and FDA databases include:
+> • List all relevant general complications
+>
+> Crucially, the scrutiny of post-market surveillance data revealed no risks unaddressed in the risk management discussion. The assessment of clinical data provides further reinforcement of the safety and performance of the device under evaluation.
+
+## 10. Benefit Risk Assessment
+
+> Provide an overview about risks and benefits for the medical device and come to a final conclusion, why the probable benefits outweigh potential risks. The following list summarises an example of the evaluation of acceptability of the benefit-risk ratio.
+> Based on the findings in the clinical data review as well as in the risk analysis, it can be inferred that the probability of a patient experiencing a substantial benefit when using the [device name] outweighs the probability of suffering harm due to a residual risk of the device significantly.
+
+## 11. Summary & Conclusion
+
+> Executive Summary: This clinical evaluation represents a methodologically rigorous ongoing process
+> encompassing the collection, assessment, and analysis of clinical data for the . The report synthesizes
+> preclinical, non-clinical, and clinical data from diverse sources, presenting crucial information about the
+> device's intended purpose. A comprehensive literature search, yielding a sufficient number of relevant
+> publications (n=xx), underscores the safety and performance of the , with identified publications meeting
+> satisfactory quality standards. The evidence supports the intended purpose, clinical performance, and
+> benefits as outlined in informational materials. No safety-related complaints, unaddressed risks, or
+> usability concerns were identified beyond those addressed in risk management.
+>
+> Market experience, involving more than xxx units sold worldwide since xxxx, provides valuable
+> insights. Safety-related complaints (xx) were reported, and a thorough search within clinical experience
+> databases (MHRA, BfArM, Swissmedic, and FDA) revealed no unevaluated risks or usability aspects. Residual
+> risks were deemed acceptable in the final risk management report, with the benefits outweighing these
+> residual risks.
+>
+> The clinical evaluation affirms compliance with relevant safety and performance requirements (Regulation
+> (EU) 2017/745, ANNEX I, clauses 1 and 8). Overall, the clinical safety, performance, and benefits
+> demonstrate that the \<medical device\> aligns with current knowledge and technological standards.
+>
+> Conclusions: The clinical evaluation confirms that the \<medical device\> complies with current knowledge
+> and technological standards, is suitable for its intended purpose and users, and offers substantial clinical
+> benefits, outweighing potential adverse effects. Evaluated clinical data, aligned with Regulation (EU)
+> 2017/745, are scientifically sound and comprehensive, supporting the device's conformity. The analysis of
+> literature, clinical data, and risk factors indicates that patient benefits significantly surpass the risk
+> of residual harm, rendering further clinical investigations unnecessary.
+>
+> A planned PMCF strategy, considering the clinical evaluation report's results, defines the process and
+> frequency of activities. In summary, the clinical safety, performance, and benefits showcased in this
+> evaluation confirm that the \<medical device\> adheres to relevant general safety and performance
+> requirements (Regulation (EU) 2017/745, ANNEX I, clauses 1 and 8).
+
+## Annex
+
+### A1 References
+
+The following table lists all relevant publications, provides a summary of the content and lists the appraisal.
+
+| Ref. | No. | Title | Summary | Indication / Application | Risks | Named Device | Benefits | Usability |
+|------|-----|-------|---------|--------------------------|-------|--------------|----------|-----------|
+|      |     |       |         |                          |       |              |          |           |
+
+### A2 Selection of Literature Search Results
+
+The following table lists all identified publications, the decision for potential relevance and final
+relevance.
+
+Use the literature assessment Excel sheet and copy paste the first columns in here.
+
+| No. | References | Potentially relevant? | Relevant after reading the full text? |
+|-----|------------|-----------------------|---------------------------------------|
+|     |            |                       |                                       |
+
+### A3 Document References
+
+Reference documents that you used in the CER (Risk management, Usability, bench testing summaries) here.
+
+### A4 Qualification of authors
+
+Provide qualification and experience of the evaluators (e.g. author, reviewer and/or approver) to demonstrate
+that the responsible person fulfils the requirements for the accomplishment of clinical evaluations.
+
+---
+
+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/CA/instructions-for-use.md

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+| Regulatory References  |                  |
+|------------------------|------------------|
+| ISO 13485:2016         | 4.2.3            |
+| ISO 20417:2021         | All              |
+
+# User Manual [enter Product Name]
+
+Version: [enter content]
+Date: [enter content]
+
+
+[Placeholder Company Address]
+Email: [enter content]
+Website: [enter content]
+
+[Placeholder CE Sign]
+[Placeholder UDI]
+
+[enter Product Name]   is a class [enter content] medical device in accordance with 93/42/EEC (for MDD) // Regulation (EU) 2017/745 (for MDR).
+UMDNS Code: [enter content]
+
+Symbols:
+
+Safety Information:
+[Placeholder Symbol]
+This symbol indicates important safety-related information.
+
+Additional Information:
+[Placeholder Symbol]
+This symbol indicates supplementary information.
+
+> On your introductory pages, explain the symbols that you use in the following sections. Take into account standards like ISO 15223.
+
+> **General Provisions:** Instructions for use are regulated in Section 13 of the Essential Requirements (MDD) and Chapter 3, Section 23 of the General Safety and Performance Requirements (MDR). You may be able to make a case for why your users must not be provided with instructions for use, based on the exception stated in Section 13.1 (MDD) or Section 23.1.d (MDR):
+>
+> "By way of exception, no such instructions for use are needed for devices in Class I or IIa if they can be used safely without any such instructions."
+>
+> **Language Requirements:** Language requirements are regulated on the national level. German Medical Device Law (Medizinprodukte-Durchführungsgesetz (MPDG), Art. 8) typically requires German, but also gives leeway to argue that English may be a language that is easily understood by your users if those are trained professionals. If you follow this route, as a minimum requirement, all safety-related information has to be provided in German nevertheless:
+>
+> "In begründeten Fällen dürfen die Informationen auch in englischer Sprache oder einer anderen für den Anwender des Medizinproduktes leicht verständlichen Sprache zur Verfügung gestellt werden, wenn diese Informationen ausschließlich für professionelle Anwender bestimmt sind und die sicherheitsbezogenen Informationen auch in deutscher Sprache oder in der Sprache des Anwenders zur Verfügung gestellt werden."
+>
+> https://www.gesetze-im-internet.de/mpdg/MPDG.pdf
+
+## Product Description
+
+### Intended Medical Indication
+
+> You can basically copy/paste your intended use document here and in the sections below. This paragraph should include high-level information required to get an idea of how your product works.
+> Describe the condition(s) and/or disease(s) to be screened, monitored, treated, diagnosed, or prevented by your software.
+> Take into account: clinical benefits to be expected, types of processed data, types of data processing (or machine learning based devices: information about algorithm accuracy).
+
+### Characterization of User Profile
+
+> Describe your users: what level of education can be assumed for your users group? Any pre-existing knowledge of the field that your device is used in?
+> What technical proficiency can be assumed, how much time is typically spent using the software?
+
+> If you plan on providing user training prior to product use, make sure to also add a description of that here.
+
+### Characterization of Patient Population
+
+> Describe the patient population your software is intended to be used on. Note that this may overlap with the user profile above, but not necessarily.
+> Your software could be used by physicians to diagnose diseases in patients, so in that case, they don’t overlap. Some ideas for characteristics to describe: Age group, weight range, health, condition(s).
+
+
+### Characterization of Use Environment Including Software / Hardware
+
+> Describe the typical use environment. What sort of devices is this running on? Does the software only run on one device or on multiple devices? Is it loud and chaotic like in an emergency ward? How’s the lighting?
+> Also, add other software or hardware which is required by your device. Most commonly, apps require users to have a smartphone with a compatible operating system (iOS / Android).
+
+### Exclusions
+
+> This is an important section for your company liability: make clear the environment your device should NOT be used in, by whom should your device NOT be used?
+
+
+## Safety Information
+
+### Contraindications
+
+> More exclusions, more specific to safety risks and clinical implications. For example, does your device automate medical diagnoses? If not, you may want to point out that all results must be checked thoroughly by a qualified physician.
+
+### Warning and Remaining Risks
+
+> You can use this section to point out user information as required for risk mitigation measures. For example, specific information that must be checked for accuracy or completeness to operate the device.
+
+### Reporting a Serious Incident
+
+> If you want to report a serious incident which occurred with this medical device, then you can do so by contacting your national competent authority under the following contact information:
+> 
+> (Add information of authorities for each country your device will be sold in)
+
+
+## Language
+
+> Self-explanatory: what languages, what language settings are offered for your product?
+
+
+## System Requirements
+
+### Hardware
+
+> What hardware configuration is required to run your device (e.g. minimum requirements for processor, display, network bandwidth)?
+
+### Software
+
+> What software configuration is required (e.g. latest browser version)?
+
+### IT-security Measures
+
+> What is required to prevent unauthorized access? How do users prevent data loss? Describe for example firewall settings, VPN setup, etc.
+
+## Installation
+
+> Describe: Is any IT integration required prior to use? How is a successful installation verified? How are login credentials dealt with?
+
+## Safety and Maintenance
+
+The software's lifetime is established to be [for example: three years]. This is what is expected to be the maximum time until the implementation of a significant change, by which the manufacturer is able to react to the relevant changes to the software device environment, such as SOUP changes, cybersecurity innovations, or the evolving technological or medical state of the art.
+
+> Consider multiple sub-sections here: how do you plan to deploy frontend / backend updates? How can users report malfunctions, clinical incidents, lost passwords or a potential security breach?
+
+Other aspects you may want to consider for the section as part of your instructions for use:
+
+ * Using the software: walkthrough guide to explain functionalities including screenshots and links to helpful websites
+ * Description of the algorithm for machine-learning based medical devices
+ * Description of alternative devices or services
+
+---
+
+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/CA/literature-evaluation-table.md

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+# 1. Introduction and Literature Evaluation
+
+Copy this table into an Excel sheet to manage your literature. Modify this table to your needs and requirements.
+
+| Search category      | No. | Reference                           | Potentially relevant? | Relevant after reading the full text? | Title                                   | PUI/PMID                | Abstract                      | Comment                 | Name of device                                                 | Clinical performance & benefits           | User experience                     | Risks                                     |
+|----------------------|-----|-------------------------------------|-----------------------|---------------------------------------|-----------------------------------------|-------------------------|-------------------------------|-------------------------|----------------------------------------------------------------|-------------------------------------------|-------------------------------------|-------------------------------------------|
+| Clinical association | 1   | Add the publication reference here. | Yes / No              | Yes / No                              | Add the title of your publication here. | Add the PubMed ID here. | Copy paste the abstract here. | Add your comments here. | Name of your device, a similar device or the equivalent device | List the clinical performance parameters. | List usability related information. | Lists risks mentioned in the publication. |
+| ...                  |     |                                     |                       |                                       |                                         |                         |                               |                         |                                                                |                                           |                                     |                                           |
+
+---
+
+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.