7 Principles of Product-Centric Quality Management

A Guide for Medical Device Innovators

Maintain Traceability and Transparency at All Times

Traceability and Transparency

Addressing Quality Issues Quickly and With Confidence

With products that focus on patient health, it is imperative to be able to identify, track, analyze, and resolve issues quickly and effectively. Many companies rely on tribal knowledge and manual or siloed processes that introduce communication delays or risk of human error.

The best approach is for companies to be proactively prepared to:

  • Confidently and efficiently trace issues back through design
  • Quickly identify causes and remedies of the immediate issue
  • Prevent issues from recurring with other patients or markets
  • Avoid the impacts of recalls, field service repairs, and elevated risk exposure

Avoiding the Agony of Audits

Audits are a constant reality for medical device manufacturers and drive the critical need for traceability and transparency. How well a team performs during internal or external audits can determine not only the success of the product, but sometimes a company’s very existence. Having the full product design history and all quality records tracked in the same system gives everyone the confidence to respond to audits effectively.

Reduce the Pains and Price of Software Validation

Validate BenefitsMedical device companies are required to validate enterprise software that is part of the quality system to ensure all functionality meets the software’s intended use. Detailed in 21 CFR 820.70(i) and 21 CFR 11.10(a), these multilayered requirements can have a major impact on business operations in the form of high costs and significant time demands on team members.

Many organizations find the process so punitive, in fact, that they choose not to install updates, upgrades, and bug fixes at all. Those decisions lead to a dangerous mismatch of cutting-edge technologies being managed by old, outdated enterprise software.

Challenge: How can medical device companies benefit from software updates and make the validation better?

Arena Validate simplifies validation so that organizations can reduce costs and the work required by internal quality and regulatory teams. This straightforward approach is comprised of three steps:

Validation Steps