Medical Device: Market Phase

How MasterControl Supports the Cross-Functional Development Team of a Medical Device Company during the Market Phase

During the market phase, when the medical device is being marketed and sold, the need for document control and collaboration software continues to be significant. Forms-based process automation solutions can also help by automating equipment maintenance/ calibration and tracking manufacturing processes. As during the commercialization phase, the automation of quality processes, such as training, change control, nonconformances, CAPAs, etc., is important during the market phase. The quality team continues to monitor manufacturing operations, and is also responsible during the market phase for resolving customer complaints. Using MasterControl analytics software, the quality team analyzes customer complaints, nonconformance issues, CAPAs, etc. for reporting purposes.

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Market Phase Software Solutions

  • Documents MasterControl
  • MasterControl Collaboration
  • MasterControl CustomerComplaints
  • Formations MasterControl
  • Other MasterControl Automation Processes
Controlled Documents Managed in the Market PhaseCollaboration Workflows During the Market Phase
  • BOMs
  • Manufacturing process documents
  • DHRs
  • SOPs
  • Inventory and supplier documents
  • Equipment/calibration documents
  • DMR documents
  • Device Analyses documents and MDRs
  • Nonconformances
  • Customer complaints and CAPAs
  • Change control documents
  • Compliance audit reports
  • Publications for professional journals
  • Research, design, and implementation documents
  • Post-market surveillance documents
  • Clinical claims testing documents and other DHF documents
  • Productive derivative documents
  • CE technical file documents for dossier
  • Other submission documents needed to secure foreign regulatory approval
  • Possible material review board (MRB) meeting documents
  • Customer Compliant and Nonconformance Issues:

    The quality, development, and, when necessary research, teams collaborate on customer complaint and nonconformance issues; the regulatory team also may collaborate (if there are letters to file for product derivatives).

  • Preparation of Publications for Professional Journals:

    The research and sales and marketing teams collaborate in the preparation of publications for professional journals; outside writers may also be part of the collaboration.

Training Management Needs

MasterControl integrates the training process with the rest of the quality system for a holistic approach to quality management. If there's a change in a document linked to a required course because of a revised SOP, policy, etc., all affected trainees immediately receive new training tasks. MasterControl's reporting and analytic capabilities include customizable reports and online charting. The system automatically performs a gap analysis for all training tasks.

Document Control and Management Needs

During the market phase, the regulatory team prepares the CE technical file(s) for the dossier, as well as other global submission documents necessary to secure foreign regulatory approval. In addition, the regulatory team may have letters to file for product derivatives. Members of the sales and marketing team also have many documents to manage during the market phase: publications in professional journals, sales and market data compilations, and competitive analyses and post-market clinical studies. A secure, centralized document repository can help both the regulatory team and the sales and marketing team by providing quick access to all product data and design documents.

MasterControl Collaboration Software:

  • Provides a web-based, virtual workspace for collaboration.
  • Decreases need for meetings among quality, development, and research teams to collaborate on customer complaint and nonconformance issues.
  • Enables members of the cross-functional team who may be offsite to collaborate.
  • Facilitates collaboration between the research team and professional writers outside the company involved in preparing publications for professional journals.
  • The ability to chunk relevant research information for outside writers facilitates the collaborative effort.
  • Creates system transparency, enabling authorized users to see where collaboration documents are in the review process.

Other MasterControl Process Automation Software Needed During the Market Phase:

  • Formations MasterControl
  • MasterControl Change Control
  • MasterControl Non conformité
  • MasterControl CAPA MD
  • MasterControl Deviations
  • MasterControl Audit

Contact MasterControl Today for More Information About Medical Device Market Phase

To get comprehensive details about the market phase of medical device companies, feel free to contact MasterControl representative today.