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Safety Requirements Add Complexity

Companies operating in industries that require compliance with regulations or functional safety standards have an added layer of complexity in their product development cycle. You must take appropriate preventative measures to safeguard your product from causing economic loss, physical harm or even death.

Automated, end-to-end traceability during development, and the ability to easily package and share the appropriate details with auditors or governing bodies, enables you to quickly show you’ve met regulatory needs.

The ability to show you’ve verified and validated that your products meet all requirements throughout the development process — from market, to system, to subsystem requirements — is critical to launch.


Application of Risk Analysis Techniques in Jama to Satisfy ISO 14971

This paper describes the main clauses of ISO 14971, the FDA’s mandatory standard for risk assessment in medical devices, and outlines how Jama Connect™ gives medical device developers a comprehensive way to manage risk and requirements throughout the product development lifecycle.


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The Challenge

Compliance and Functional Safety Management Mitigate Risks

Companies battle risk on two fronts. You’re reducing liability to the patient or end user by satisfying safety requirements. But it’s also critical to alleviate organizational threats by enhancing the process you use to prove that you’ve considered and appropriately mitigated all foreseeable risks. When building critical products, you’re documenting for yourself internally, and externally for the regulatory body.

Digitizing information in a straightforward solution enables authors and contributors to own their data. It also gives content owners visibility into relationships up and down stream to better manage change.

Unnecessarily introducing risk

In legacy systems, data flows through a central gatekeeper due to tool accessibility. This user is typically not the author of the information, yet is charged with determining its legitimacy and if it should enter the system. This introduces risk because of manual transcription and the possibility that pertinent information related to safety requirements could be left out or misinterpreted. Using documents also invites additional uncertainty, as important information could easily be lost through mishandled version control or uncaptured functional safety data.

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The Solution

Don’t Gamble With Safety Requirements

Getting compliance or functional safety right is a trifecta: people, process and tools all have to be in line. But it shouldn’t be anxiety-inducing. Risk management is the responsibility of everyone in the company. Each employee should be thinking about regulations and functional safety standards during development and aligning their processes to be compliant.

An advanced product development solution shows you’re taking the necessary steps to manage risk. Whether you validate the solution or export pertinent data for submission, you’re able to prove compliance or functional safety with automatic traceability from requirements definition all the way through verification and validation.

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Our Platform

Confidently Prove Adherence to Regulatory and Safety Standards

A modern solution for product development enables teams to decrease risk, successfully prove compliance with regulations or functional safety standards and get safer products to market faster.

Benefits of Jama Software for compliance or functional safety:

  • View how tests track back to requirements to prove quality and compliance
  • Inspect relationships from requirements through all levels of related items, including risk
  • Mark downstream items as suspect and automatically notify team members when upstream items are modified
  • Customize requirements exports to meet your organization’s unique format, as well as standard commercial and military formats
  • Have a single source of truth for clear visibility throughout the development process
  • Reuse validated requirements to quickly replicate features across products without introducing additional risk
  • Instill confidence in your product development solution with TÜV SÜD “fit-for-purpose” certification

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