Cognition Corporation’s Product Development Lifeline™ Program


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Let us help you achieve FDA compliance for your medical devices (Class I, II, or III)

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Requirements Management – Test Management – Risk Management

For a single, fixed price, Cognition will create your requirements, test, and risk management documents, traces, and reports to meet or exceed industry standards for medical devices.

The Cognition Lifeline Team™ will work with your organization to prepare the appropriate documents and traces for your company. Our team members each have many years of senior level experience in medical device compliance and can advise you on best practices in the industry. If you do not already have your own standards for product development documentation, Cognition will provide you with the best in class industry standard document formats to ensure compliance.

Cognition will leave you with your own complete system containing all your product development documents on the web:

  • The system we leave is yours and is reusable by you for all your future programs
  • You don’t need Cognition to come back again for each new program
  • Host the site on your own network or let Cognition host it for you (SaaS)

A Typical Document Flow for medical device product development:

Product Development Flow (click to enlarge)

Following is a list of some common documents generated during Cognition’s Product Development Lifeline™ program:

  • Market Specifications
  • Voice Of Customer
  • Marketing Requirements
  • Product Requirements
  • Systems Requirements
  • Customer Requirements
  • Software Requirements
  • Software Specification
  • Hardware Specifications
  • Validation Plans
  • Verification Plans
  • Test Protocols
  • Hazard Analysis
  • Design Control
  • Process FMEA
  • Design FMEA
  • Fault Tree Analysis
  • Design History File
  • Device History Record
  • Device Master Record
  • Manufacturing Process Instructions

Five Easy Steps To Product Development Compliance

The Cognition team will lead you through these steps and leave you with a complete system for product development compliance:

  1. Identify your compliance deliverables
  2. Identity working documents needed to generate deliverables
  3. Create document and links between documents
  4. Set up web site software
  5. Train your team how to fill out and export your documents/deliverables

Contact us to set up one hour web session to introduce Cognition’s Product Development Lifeline™ Program.

Drowning man being thrown a lifeline