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Medical Device Regulation


MasterControl Helps Developers Comply with Medical Device Regulation Requirements

Manufacturers doing business in life sciences industries are subject to a wide spectrum of medical device regulation requirements. The GxP process management solutions available from MasterControl Inc. have been specifically engineered to allow medical device manufacturers to comply with industry standards and take a fully compliant product to market.

The integrated, user-friendly software solution suite provided by MasterControl has been expressly tailored to meet the needs of companies doing business in regulatory environments that must comply with stringent industry regulations. These include medical device regulation requirements such as 21 CFR Part 820, the FDA’s guidelines for the regulation of quality systems related to the methods used in and the facilities and controls used for design, purchasing, manufacturing, packaging labeling, storing, installing, and servicing of medical devices. The MasterControl solution is also designed to promote companies’ ability to maintain compliance with ISO medical device regulation standards, including guidelines for quality systems (ISO 9000 and ISO 13485) as well as environmental management standards (ISO 14000).

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How MasterControl Can Help Your Company Comply with Medical Device Regulation Standards

Here are some of the complementary features and functions of MasterControl’s GxP process management solutions—available individually or as an integrated suite—that can assist your regulated organization in maintaining compliance with current medical device regulation requirements:

  • MasterControl Documents™ automates the routing, escalation, approval, and delivery of standard operating procedures (SOPs), policies, and other documentation. The centralized, Web-based document repository provided by the MasterControl system is secure yet easily accessible to authorized users.
  • MasterControl CAPA™ allows medical device manufacturers to integrate their corrective and preventive action processes with other quality processes. MasterControl’s CAPA solution incorporates the best-practice “8D” process with customizable reporting capabilities. The system automatically enters relevant data into CAPA forms and allows CAPA forms to be launched directly from other forms, such as nonconformance reports. MasterControl eliminates human errors and reduces the amount of time spent manually entering data, allowing companies to be more efficient and fully compliant with medical device regulation requirements.
  • MasterControl Nonconformance™ helps medical device developers comply with medical device regulation guidelines by automating, electronically managing and streamlining the processes used to identify, evaluate, review, and handle nonconforming materials (e.g., components, parts and finished products). The solution makes it possible to either maintain a stand-alone nonconformance process for smaller, localized incidents or to be connected to the CAPA process for automatic escalation as warranted.
  • MasterControl Customer Complaints™ facilitates compliance with medical device regulation requirements by simplifying the complaint handling process and reducing the lifecycle time from submission to resolution. The system provides pre-configured multi-page forms that incorporate a straightforward, three-step process to handle customer complaints: first the complaint is processed, which leads to an internal investigation, and culminates with issue resolution.
  • MasterControl Audit™ allows manufacturers to better comply with medical device regulation requirements by automating and efficiently managing the audit process. The audit solution provides advanced tracking capabilities, from scheduling and planning to execution and completion. The system offers best practice forms for tracking basic audit information and audit findings. MasterControl can automatically schedule all recurring audit-related activities and provides analytics and reporting capabilities that increase management visibility.
  • MasterControl Training™ automates the assignment and supervision of training tasks. Training assignments can be sequentially launched after the completion of prerequisites and exams can be graded online. 

About MasterControl
A global leader in the field of GxP process management solutions since 1993, MasterControl Inc. offers a comprehensive, user-friendly system that makes it possible for companies to achieve and sustain regulatory compliance. Hundreds of companies around the world depend on MasterControl solutions to comply with the multitude of pharmaceutical and medical device regulation requirements.

For additional information about medical device regulation topics please visit MasterControl’s Resource Center. The Resource Center provides research and educational materials such as white papers, case studies, and similar complimentary downloads.

Contact Us
Do you want to learn more about how MasterControl’s GxP process management solutions can help resolve your medical device regulation issues? Our expert team is available to answer your questions. Call toll free at 800-825-9117 or contact us online.