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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11 Free Resources to Boost Your Medical Device FDA Readiness

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Hundreds of companies around the world use MasterControl to automate core business processes and document management activities to promote collaboration, improve decision making, and accelerate time to market.

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Analyst Report: A Road Map for Addressing Quality and Manufacturing Challenges in Life Sciences (LNS Research)
Data Sheet: MasterControl eMDR Data Sheet: MasterControl eTMF Manager for Medical Device
Kit: 11 Free Resources to Boost Your Medical Device FDA Readiness
White Paper: Most Common Reasons for FDA Form 483 Observations and Warning Letters in Medical Device Environments
Trend Brief: 2024 Medical Device Industry Trends

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.

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.