Pitches New Medical Device Risk Management Software, a quality management, design control, and now risk management solution provider for medical device companies, has announced the release of its brand new risk management software feature set.

Background’s boast is that it produces beautifully simple software solutions for medical device companies to allow them to bring high quality products to market faster, while reducing risk and simplifying regulatory compliance. The company’s eQMS software solution provides device makers a Single Source of Truth by integrating the management of design controls, risk, controlled documents, and quality processes in one, easy to use, cloud-based platform, claimed to be the first and only software solution designed to align directly with the ISO 14971 standard for medical devices.

So what does it deliver? Well, according to a company press release, and without labouring the details, the features include:

  • Paperless, “Living” Risk Management File, kept up to date and “living” throughout the entire product lifecycle.
  • Risk Management as a Tool, integrating device makers’ risk management processes across their entire quality management system.
  • Comply with ISO 14971 & 21 CFR Part 820: Designed specifically to help device makers ensure compliance with government regulations and industry standards such as 21 CFR Part 820 and ISO 14971.
  • Risk Management tied to Design and Development Activities: By seamlessly linking risk management activities to the product development design control traceability matrix, users are able to toggle back and forth between design controls and risk management with the click of a button.
  • Easily Configureable Risk Acceptability Matrix: Users can clearly identify risk acceptability criteria with an easy to use, graphical interface that directly ties to the design control matrix. points us here for more details of its new risk management solution.

Company comments

“The future of medical device quality systems and documentation is going to look a lot different than the past,” CEO and Co-founder David DeRam explained.

He continued, “Regulatory bodies such as FDA and EU Competent Authorities expect risk management activities to be part of the design controls process and for the risk management file to be living throughout the product’s whole lifecycle. We’ve had the opportunity to speak with hundreds of medical device companies and have learned that our customers are interested in making risk management part of the entire product lifecycle. This allows them to not only build better products, but to run better businesses.”

Source: PR Web





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