Cockpit is a product development compliance and commercialization platform used to aid in the development of medical devices, pharmaceuticals, and combination products. The powerful database allows teams to trace the product development process from concept through commercialization and into postmarket.

Cognition provides sets of pre-defined online templates that allow for a simple, guided environment to complete exercises required for regulatory submissions. The templates live inside the Cockpit Platform, which is the engine powering them. Templates are updated from time to time by Cognition to maintain consistency with updated standards and regulations.

All content created within the template is captured, stored, and managed in the secure underlying database, allowing content to later feed into other templates that are part of the development process. This progression through the guided templates builds a set of deliverables suitable for both FDA and EU Notified Body submissions.

Learn more about our current templates:

Cognition’s Template for PHA Exercises

Preliminary Hazard Analysis is a commonly available method of risk management defined as “a tool of analysis based on applying prior experience or knowledge of a hazard or failure to identify future hazards, hazardous situations, and events that might cause harm, as well as to estimate their probability of occurrence for a given activity…” – Section 1.7, Annex I: Risk Management Method and Tools, Q9 Quality Risk Management

The PHA template allows teams to create a PHA using pre-defined lists of perspectives, questions proposed by the guiding ISO and IEC standards, and pre-populated Harm and Hazard libraries. These libraries provide generic harms and hazards commonly encountered in development.

Cockpit’s out-of-the-box PHA template is designed to comply with the following regulations:

  • ISO 14971 – Application of Risk Management to Medical Devices
  • IEC 62366 – Application of Usability Engineering to Medical Devices

It promotes “inherent safety by design” by guiding users through detailed risk analysis early in the design phase of the system. It reduces development costs and time to market by minimizing system redesigns in the later stages of product development.

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    DEVELOP PERSPECTIVES

    The template comes preconfigured with perspectives (User, Maintainer, Patient), but more may be added as required.

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    HAZARDS LIBRARY

    The template comes preconfigured with the hazards identified in Annex E of ISO 14971:2012, split into four categories. Additional hazards and categories may be added as required.

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    HARMS LIBRARY

    The template comes preconfigured with harms and associated severities. Additional harms may be identified and severities assigned as required.

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    GUIDED Q&A: APPLICATION OF RISK MANAGEMENT TO THE MEDICAL DEVICE

    The template comes preconfigured with a non-exhaustive list of questions identified in Annex C of ISO 14971:2012 to assist with “identifying the characteristics of the medical device that could affect safety”. Additional questions may be added as required.

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    AUTO GENERATE PHA TABLE

    The template automatically inserts the hazards identified as a part of answering the risk management and usability questions into the PHA table. The user is then prompted to identify hazardous situations, sequences of events, harms, and risk (severity and occurrence) for each hazard, before defining mitigations and residual risk for each overall risk.

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    GUIDED Q&A: APPLICATION OF USABILITY TO THE MEDICAL DEVICE

    The template comes preconfigured with a non-exhaustive list of questions identified in Annex E of IEC 62366:2008 to assist with “identifying the usability characteristics of the medical device that could affect safety”. Additional questions may be added as required.

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    COMPLETE THE RISK CONTROL MATRIX

    The template automatically inserts the mitigations identified in the PHA table into the risk control trace matrix. The user is then prompted to link mitigations to existing requirements.

Cognition’s Template for Design Controls

21 CFR 820.30 outlines the regulations for Design Control of medical devices. The regulation is broken up into ten subsections detailing the tasks necessary to be compliant. The guidance is written in a way that leaves it open for interpretation. The Cognition Design Control template combines FDA best practices with the standard itself, leaving little room for error in the design process.

This template was created to give teams an easy way to start creating and capturing requirements, validation tests, and verification tests in accordance with 21 CFR 820.30.

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    820.30(A): GENERAL

    Each manufacturer of any class III or class II device, and [some] class I devices…

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    21 CFR 820.30(a): General:

    "€œEach manufacturer of any class III or class II device, and [some] class I devices, shall establish and maintain procedures to control the design of the device in order to ensure that specified design requirements are met."

    Not all devices are required to adhere to the Design Control standard. Those required to comply are specified in 820.30(a).
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    820.30(B): DESIGN AND DEVELOPMENT PLANNING

    Each manufacturer shall establish and maintain plans that describe or reference the design and development activities and define responsibility for implementation. The plans shall…
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    21 CFR 820.30(b): Design and Development Planning

    "Each manufacturer shall establish and maintain plans that describe or reference the design and development activities and define responsibility for implementation. The plans shall identify and describe the interfaces with different groups or activities that provide, or result in, input to the design and development process. The plans shall be reviewed, updated, and approved as design and development evolves."

    The Design Control Template provides a location for you to enter all this necessary information required by this subsection.
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    820.30(C): DESIGN INPUT

    Each manufacturer shall establish and maintain procedures to ensure that the design requirements relating to a device are appropriate and address the intended use of the device, including…
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    21 CFR 820.30(c): Design Input

    "€œEach manufacturer shall establish and maintain plans that describe or reference the design and development activities and define responsibility for implementation. The plans shall identify and describe the interfaces with different groups or activities that provide, or result in, input to the design and development process. The plans shall be reviewed, updated, and approved as design and development evolves."€

    The Design Control Template provides a location for you to enter all this necessary information required by this subsection.
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    820.30(D): DESIGN OUTPUT

    Each manufacturer shall establish and maintain procedures for defining and documenting design output in terms that allow an adequate evaluation of conformance to design input requirements. Design output…

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    21 CFR 820.30(d): Design Output

    "Each manufacturer shall establish and maintain procedures for defining and documenting design output in terms that allow an adequate evaluation of conformance to design input requirements. Design output procedures shall contain or make reference to acceptance criteria and shall ensure that those design outputs that are essential for the proper functioning of the device are identified. Design output shall be documented, reviewed, and approved before release. The approval, including the date and signature of the individual(s) approving the output, shall be documented."

    The Design Controls template provides a simple way for you to flow down from high level market requirements all the way down to design outputs. The Cockpit Platform makes creation and allocation of design outputs simple. Built-in trace matrices provide a top-level view of all connections made within the template.
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    820.30(E): DESIGN REVIEW

    Each manufacturer shall establish and maintain procedures to ensure that formal documented reviews of the design results are planned and conducted at appropriate stages of the device’s design development…

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    21 CFR 820.30(e): Design Review

    "Each manufacturer shall establish and maintain procedures to ensure that formal documented reviews of the design results are planned and conducted at appropriate stages of the device's design development. The procedures shall ensure that participants at each design review include representatives of all functions concerned with the design stage being reviewed and an individual(s) who does not have direct responsibility for the design stage being reviewed, as well as any specialists needed. The results of a design review, including identification of the design, the date, and the individual(s) performing the review, shall be documented in the design history file (the DHF)."

    Cockpit provides a comprehensive review feature, allowing you and your team to systematically review every aspect of your design control plan. Configurable workflow capabilities and Engineering Change Requests allow you more flexibility in how reviews are created and executed. Cockpit includes electronic signatures to maintain Part 11 compliance.
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    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…

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    21 CFR 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."

    Verification tests can be created for system requirements, device product requirements, subsytem requirements, and design outputs, or tests can be linked in from an external system using Cockpit's open API. All test execution steps and milestone-based results are stored within Cockpit'€™s powerful database.
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    820.30(G): DESIGN VALIDATION

    Each manufacturer shall establish and maintain procedures for validating the device design. Design validation shall be performed under defined operating conditions on initial production units, lots, or batches, or their equivalents. Design validation shall…

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    21 CFR 820.30(g): Design Validation

    "Each manufacturer shall establish and maintain procedures for validating the device design. Design validation shall be performed under defined operating conditions on initial production units, lots, or batches, or their equivalents. Design validation shall ensure that devices conform to defined user needs and intended uses and shall include testing of production units under actual or simulated use conditions. Design validation shall include software validation and risk analysis, where appropriate. The results of the design validation, including identification of the design, method(s), the date, and the individual(s) performing the validation, shall be documented in the DHF."


    The template provides an easy way for you to enter validation tests and allocate them to the appropriate User Needs. Test results can be marked and stored into the Cockpit database using simple UI commands. Full test results are easily exportable for use in regulatory submissions.
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    820.30(H): DESIGN TRANSFER

    Each manufacturer shall establish and maintain procedures to ensure that the device design is correctly translated into production specifications…

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    21 CFR 820.30(h): Design Transfer

    "Each manufacturer shall establish and maintain procedures to ensure that the device design is correctly translated into production specifications."

    Cockpit facilitates design transfer by allowing you to export trace matrices and test results accumulated in the template out to PDF or Word. These documents can then be passed on to the next link in the supply chain.
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    820.30(I): DESIGN CHANGES

    Each manufacturer shall establish and maintain procedures for the identification, documentation, validation or where appropriate verification…

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    21 CFR 820.30(i): Design Changes

    "€œEach manufacturer shall establish and maintain procedures for the identification, documentation, validation or where appropriate verification, review, and approval of design changes before their implementation."

    The Cockpit Platform facilitates design change in the design control process by providing an extensive Engineering Change Request feature as well as electronic signatures as part of configurable workflows. Cockpit is Part 11 compliant.
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    820.30(J): DESIGN HISTORY FILE

    Each manufacturer shall establish and maintain a DHF for each type of device. The DHF shall contain or reference the records necessary to demonstrate…

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    21 CFR 820.30(j): Design History File

    "€œEach manufacturer shall establish and maintain a DHF for each type of device. The DHF shall contain or reference the records necessary to demonstrate that the design was developed in accordance with the approved design plan and the requirements of this part."

    The Design Control Template automatically creates multiple trace tables showing connections between parent and child requirements in the project. These trace tables can be exported to PDF, Word, or Excel and included as part of the Deisgn History File (DHF) submitted to FDA.
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Cognition’s Templates for FMEA Exercises

Failure Modes Effect Analysis (FMEA) “… provides for an evaluation of potential failure modes for processes and their likely effect on outcomes and/or product performance” – Section I.2, Annex I: Risk Management Method and Tools, Q9 Quality Risk Management. Risk mitigation through FMEA exercises reduces or controls potential failures by breaking down risk analysis for complex systems into manageable steps. It is an effective tool for identifying important failure modes, contributing factors/causes, failure consequences, and mitigations.

The FMEA templates guide teams through completion of FMEA exercises for uFMEA, dFMEA, and pFMEA. . Cockpit allows teams to configure risk score calculations using either simple scoring thresholds or user-defined color lookup matrices. Cockpit FMEA templates also support risk libraries commonly used in product development and postmarket surveillance.

Cockpit’s FMEA templates are configurable to meet regulations/standards, including:

  • ISO 14971 – Application of Risk Management to Medical Devices
  • IEC 60812 – Analysis Techniques for System Reliability
FMEA promotes safety by identifying elements and operations within a system that render it vulnerable; outputs of FMEA exercises can be utilized for further risk analysis or design change. As each FMEA exercise is completed, users define controlling requirements for all mitigations to tie risks into requirements in Cockpit.

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    CONFIGURABLE SCORING

    Product development teams can set and define scores and ranges for risk severity, probability of occurrence, and detectability. Matrices or straight threshold calculations can be configured to reflect scores.

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    RISK LIBRARIES

    Cockpit includes several pre-populated risk libraries to guide teams through FMEA exercises. Set up your own risk libraries or modify pre-configured ones within Cockpit. The platform support libraries for failures, hazards, harms, complaints, etc.

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    SUPPORTED FMEA TEMPLATES

    • uFMEA — Identify use-related risks and work out all possible use scenarios leading to failure and potential failure consequence
    • dFMEA — Apply FMEA method specifically to device or product design
    • pFMEA — Identify and evaluate potential process failures

    Develop multiple risk exercises for use cases and human factors, functional studies including connections to system BOM and mapping out app process definitions to predict risk of failure and identify appropriate mitigations.

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    TYING RISKS TO REQUIREMENTS AND TESTS

    Implement mitigations by designating controlling requirements to show interactions between risks and requirements; verify implementation through Cockpit’s testing features. Out of box templates empower dynamic connections between all design controlled documents, meaning risks can be tied back to requirements in a real-time, dynamic environment.

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    POST MARKET

    Field complaints can be fed back into FMEA templates as actual occurrences of a failure to help support postmarket surveillance and the Corrective and Preventive Action (CAPA) process. Templates support both pre-and post-mitigation scoring algorithms.

Cognition’s Template for Human Factors


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    CONTEXTUAL INQUIRY

    Understand the context of use for the device you are creating. What type of person is going to be using it? What environment will it be used in? What are your tasks to proceed?

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    RISK ANALYSIS

    Understand what could possibly go wrong. Take what you have learned from your contextual inquiry and dissect the harms and hazardous situations that lead to those harms. Use common risk management techniques to ensure total coverage over all scenarios.

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    USER INTERFACE SPECIFICATION

    What are your acceptance criteria for knowing you have a successful design? This is where you spell it out. Does your device meet the expectation of the user? During this phase, define what the user is expecting to ensure the device is designed as specified.

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    ITERATIVE DESIGN

    Create a rapid prototype or wireframe of your device. Early usability testing also occurs at this phase of the Human Factors Engineering lifecycle.

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    USABILITY TESTING

    Formative and Summative testing is done to ensure that your device is on the right track. Formative testing is done early in the process. It is used to identify key areas that may change the overall design of the device, among other things. Summative testing, also called Validation Usability testing, is done to prove the final design performs as desired/intended.