Medical Device: Commercialization Phase

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

During commercialization, manufacturing begins producing inventory as quickly as possible, so that, once regulatory approval or clearance is received, sales can begin immediately. Manufacturing team members also complete their process validations and manufacturing procedures, and - based on marketing sales forecasts - develop long-term purchasing plans. Training operators on new processes and equipment is also important during this phase. MasterControl Training software can facilitate this process and ensure FDA/ ISO compliance (both of which require documented evidence of training and competence).

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As full-scale production gets underway, the quality assurance team implements the quality plan and begins playing an active role in making sure that all components, raw materials, and finished goods are in compliance with device master record (DMR) specifications. The quality team also investigates nonconformance issues, CAPAs, etc. MasterControl reporting and analytics software can help in this area. Process Automation software can also help during the commercialization phase, by automating the management of nonconformances, CAPAs, product changes, supplier audits, and deviations.

Commercialization Phase Software Solutions

  • MasterControl Training
  • MasterControl Collaboration
  • Other MasterControl Automation Processes

Controlled Documents Managed in the Commercialization Phase

Collaboration Workflows in the Commercialization Phase

  • Nonconformances
  • CAPAs
  • Validation testing protocols and reports
  • Device Master Record (DMR)
  • Device History Record (DHR)
  • Submissions to international geographies
  • Post-marketing studies documents
  • FDA correspondence
  • Quality plan
  • SOPs
  • Marketing sales forecasts
  • When necessary, research and development engineers may collaborate with manufacturing to help resolve problems on the manufacturing floor.
  • Development and quality engineers assist the regulatory team with the regulatory submission.
  • Manufacturing develops their long-term purchasing plans based on Sales Marketing forecasts.
  • Sales & Marketing professionals collaborate with the development team and with the regulatory team to create collateral, sales tools, and other support materials.

For more efficient and effective training on SOPs, work instructions, quality systems regulations (QSR), etc., MasterControl provides:

  • Secure, centralized repository for all training-related records and documents.
  • Automation of the training control process, including routing, tracking, escalation, and verification of training tasks.
  • Automatic grading of online exams, which serves as proof of personnel competency during inspections and audits.
  • Connectivity between training and document control processes. When a linked document is approved, it automatically triggers training tasks for all affected trainees.
  • Ability to sequence training courses; as soon as a trainee completes a prerequisite, the next course is automatically launched.

Benefits of MasterControl Collaboration Software

  • Provides a web-based, virtual workspace for collaboration.
  • Greatly reduces the need for face-to-face meetings among cross-functional team members collaborating on, for example, manufacturing documentation or marketing support materials.
  • Enables members of the cross-functional team who may be offsite to collaborate.
  • Facilitates collaboration between research engineers/ scientists and experts outside the company, ensuring timely access to the most current research and breakthroughs.
  • The ability to chunk data for particular audiences or purposes facilitates collaborating with outside resources.
  • Creates system transparency for authorized users, allowing senior management and members of the cross-functional team to see where a design concept is in the review process.

MasterControl Process Automation Software Needed During the Commercialization Phase

  • MasterControl Documents
  • MasterControl Change Control
  • MasterControl Nonconformance
  • MasterControl CAPA MD
  • MasterControl Deviations
  • MasterControl Audit

Learn More About Medical Device Commercialization Phase

To get in-depth detail about medical device commercialization phase, contact MasterControl representative today.