Software streamlines FDA compliance, accelerates validation.June 19, 2008 -
FMEA-Med v7.5 enables medical device companies to streamline US FDA compliance through templates that can be configured to organization's preferences and internal vocabulary. Single risk file, linking hazard analysis, Failure Mode and Effects Analysis (FMEA), design verification, and post market surveillance, can be managed by user, while audit trail logs changes according to industry requirements. Release management feature re-versions document each time changes are made.
(Archive News Story - Products mentioned in this Archive News Story may or may not be available from the manufacturer.)
Original Press release
Dyadem International Ltd.
9050 Yonge Street, Suite 401
Richmond Hill, ,
Canada
Dyadem Streamlines FDA Compliance and Fast Tracks Software Validation with FMEA-Med 7.5
TORONTO, June 5 -- Dyadem today announced that with its latest FMEA-Med software release, medical device companies can now streamline their U.S. Food and Drug Administration (FDA) compliance tests. Dyadem, the leader of Risk Lifecycle Management and Quality Lifecycle Management solutions has thousands of users in the medical device industry. With its years of experience, Dyadem has enhanced the configurable templates in its FMEA-Med application and helps fast track FDA validation of its software.
Software validation is a requirement of the Quality System regulation
-- Title 21 Code of Federal Regulations (CFR) Part 820. Software that is used in conjunction with the device manufacturer's quality system must go through a strict validation process. This helps to avoid software defects in medical devices and prevents recalls of devices.
Between 1992 and 1998, the FDA analyzed 3140 medical device recalls and found that 242 of them were due to software failures. Of those software related recalls, 79 percent were caused by software defects that were introduced when changes were made to the software after its initial production and distribution. The strict guidelines ensure that medical devices reach the public market only after the assurance that quality has been incorporated throughout the lifecycle.
FMEA-Med is a software solution that delivers industry-standard Failure Mode and Effects Analysis (FMEA) to ensure quality and prevent flaws in medical devices and pharmaceuticals. Dyadem's newest FMEA-Med 7.5 helps medical device and pharmaceutical companies streamline their compliance through templates that can be easily configured to an organization's preferences and internal vocabulary. Dyadem's 15 years of experience working with companies that must comply with FDA regulations gives its customers an advantage when beginning an FMEA analysis.
"With this release of FMEA-Med 7.5, Dyadem is leading the way for our customers to meet new FDA requirements for post-market surveillance and risk management processes that span the entire risk lifecycle," said Kevin North, president and CEO of Dyadem. "By enabling customers to manage a single risk file that links hazard analysis, FMEA, design verification and post market surveillance, FMEA Med 7.5 ensures risk management is proactive, comprehensive, and up-to-date."
New in this release of FMEA-Med is enhanced compliance with 21 CFR, Part 11, which regulates the use of electronic records and signatures. Other new features that help simplify FDA compliance include:
-- An audit trail that logs changes according to industry requirements, providing the who, what, when and where each time a change is made. This transparency is imperative for compliance.
-- Improved release management that re-versions a document each time changes are made so that users can roll back to previous versions and log statistics at that time.
-- A new single sign feature with Windows authentication that provides the ability to link to an organization's Windows Active Directory in order to authenticate and validate users.
About Dyadem
Founded in 1993, Dyadem is the market leader in Quality Lifecycle Management and Risk Lifecycle Management solutions. Dyadem provides software and services that empower companies to manage quality, mitigate risks, achieve regulatory compliance, plan for business continuity and improve profitability. Dyadem works with 85% of the Fortune 500 companies and serves the high tech & electronics, medical devices, oil and gas, chemical, automotive, pharmaceutical and aerospace and defense industries. For more information, visit www.dyadem.com.
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