BALANCE LIFE SCIENCE PRODUCT QUALITY AND COMPREHENSIVE REGULATORY COMPLIANCE

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:

DESIGN CONTROLS TEMPLATE

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.

Tools and features to help empower iterative design controls activities throughout your product lifecycle:

Preliminary Hazard Analysis Template

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.

USE ERROR ANALYSIS TEMPLATE

Use Error Analysis (UEA) is a usability risk analysis tool for identifying what device functions are vulnerable to risk. UEA incorporates use specifications, function & task analysis, use scenarios, and use environments to understand the context of device use, and how it exposes users to hazards and (potentially) harms.

Cognition's templated approach guides users through UEA exercises and supports in satisfying FDA’s “inherent safety by design” principle. The UEA template allows teams to identify use errors, calculate risk scores, and link risks to requirements, tests, controls, etc.

The UEA Template meets the following standards/regulations:

  • ISO 14971, Application of risk management to medical devices
  • IEC 62366-2, Guidance on the application of usability engineering to medical devices

FMEA TEMPLATE

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.

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.

Start a discussion with us today!

Get Started