IBS Releases CompliantPro^MD Software For Medical Device Manufacturers

Lexington, MA - IBS, a global leader in enterprise quality and compliance solutions, recently announced the release of CompliantPro^MD software for medical device manufacturers. CompliantPro^MD is the latest addition to the IBS Web-based compliance software product line and is designed to help medical device manufacturers build and maintain safe and effective devices and comply with FDA QSR requirements, ISO 13485 and ISO 14971.

CompliantPro^MD provides sophisticated features with an easy-to-use interface to help medical device manufacturers build comprehensive quality systems. CompliantPro^MD streamlines operations and stores documentation, so that manufacturers can adhere to strict industry guidelines throughout the design, development and production phases. The solution includes capabilities for tracking customer complaints, assessing risks, managing employee training, and performing corrective actions. Using the product's search capabilities, users can quickly access all needed documentation at any stage, enabling them to achieve efficient, sustainable compliance.

"With IBS software, we've successfully managed documentation, streamlined corrective actions, and maintained FDA and ISO 13485 compliance," said Deborah Akmakjian, Senior Compliance Manager for TissueLink Medical Inc., a manufacturer of proprietary hemostatic devices for surgery.

CompliantProMD is a platform-independent, Web-based solution that runs on industry-standard relational databases, email systems, Web application servers, directory services and portals. The software offers easy access to user tasks and functions via a centralized dashboard. CompliantPro^MD enables companies to achieve all their compliance and quality-related goals, fostering a "Culture of Compliance."

CompliantPro^MD features include:

• Corrective and Preventative Actions (CAPA): creates Corrective Action Requests (CARs) and Preventative Action Requests (PARs) from customer complaints, audits, NCMRs, and other sources; provides real-time tracking of the status of action requests.
• Document Control: maintains secure, detailed documentation for products and processes, including Device Master Records, Device History Records, and Design History Files; also retains document revisions for the entire life cycle of the product.
• Enterprise Risk Management: performs risk assessments that get to the core of product and process issues and then facilitates the creation and monitoring of controls to mitigate identified risks.
• Environmental, Health & Safety Management: meets the EH&S requirements of the FDA and ISO.
• Customer Complaint Management: records, investigates and helps resolve customer complaints; tracks complaints by product, customer and supplier.
• Employee Training & Qualification: defines and tracks training requirements, and monitors each employee's job qualification information.
• Calibration: maintains manufacturing equipment and performs traceable calibrations; creates detailed schedules for calibration and preventative maintenance activities.
• Advanced Product Quality Planning (APQP): enables quality planning during the development process of devices.
• Incident Reporting: provides tools that comply with the FDA's requirements for MDRs, Corrections and Removals.

"Given the level of documentation required in medical device manufacturing and our expertise in developing compliance management solutions, CompliantPro^MD is a natural extension of the IBS compliance software product line," said Matthias Grossmann, CEO, IBS America. "With this new product, IBS gives medical device manufacturers the tools they need to be sure that they have complete control of the compliance process and are adhering to FDA and ISO standards."

Additionally, in a recent benchmark report published by Aberdeen Group, "The Cost of Quality Matters: Benchmarking Enterprise Quality Management," Aberdeen Group provides recommendations around key capabilities manufacturers need to achieve superior performance. CompliantPro^MD comes prepackaged with capabilities outlined in this study. Furthermore, in a ranking Aberdeen did of IBS customers, the company's customers were ranked at par with Best-in-Class performers in three key performance indicators. For additional information on the findings of this benchmark report, visit the IBS Web site (www.ibs-us.com).

SOURCE: IBS