Medical Device Software Systems

Medical Device Software Systems Automate Business Processes for Medical Device Companies

MasterControl offers the utopian solution for medical device manufacturers: an end-to-end software solution that enables companies to get their products to market faster while simultaneously maintaining regulatory compliance. By utilizing the MasterControl medical device solution, cross-functional teams can efficiently collaborate on critical documents and processes and accelerate the development cycle.

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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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Free Resources

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

Who Benefits from MasterControl Medical Device Software System?

Product Development and Engineering: MasterControl readily manages the continual flood of product spec iterations and keeps manufacturing, purchasing, document control, and the supply chain up to date. MasterControl also allows design engineers to work in the CAD environments where they are most comfortable while at the same time helping them to remain in compliance without hampering the development cycle.
Manufacturing/Operations: With MasterControl, manufacturing and operations personnel are connected to the development process earlier and they are able to provide input that will reduce manufacturing costs and get the supply chain lined up sooner. MasterControl insures that documentation used in the manufacturing process is always up to date and robust training management tools affirm that operator training records are current.
Quality: MasterControl helps quality professionals avoid common QMS pains such as CAPA, complaints, and audits and provides more insight into the development process and resulting documentation. Quality professionals can use MasterControl to track and trend quality metrics using the system's built-in analytics tools and scheduled reports. In addition, MasterControl can be utilized to leverage the quality feedback loop in order to improve product design and reduce failures in the field.
Purchasing: MasterControl provides purchasing departments with a single source for product specifications and approved vendor information. Managers can see changes in processes and use the system to enhance efficiency and prevent rework and scrapped product. MasterControl provides the assurance that purchasing decisions will always be based on accurate and up-to-date data.
Regulatory: MasterControl provides regulatory professionals with the means to easily collaborate with the cross-functional development team to assemble documentation for submissions to regulatory bodies such as the FDA. Furthermore, correspondence with regulatory agencies may be stored and tracked in MasterControl, thus providing a single access point for all regulatory information.

Features and Benefits of the MasterControl Software

Accelerate Time to Market:

Medical device companies can launch their products to market faster by using MasterControl to enable the entire development team to execute and communicate their tasks more efficiently using the tools with which they are already familiar and proficient. Some of the benefits that MasterControl offers that can help get medical devices to market faster include:

Collaboration workspaces that have the capability to involve multiple departments, outside suppliers, consultants, etc.
A means to effortlessly organize design history files and technical dossiers
Electronic collaborations and approvals across geographically dispersed design teams that maximize the effectiveness of design reviews and smooth the design transfer to manufacturing
Automated approval workflows that eliminate time otherwise wasted waiting for approval signatures
A Web-based system that involves manufacturing, marketing, quality, and regulatory personnel early in the development cycle to maximize the likelihood of product success.

Makes Efficiency and Compliance Synonymous:

MasterControl offers out-of-the-box, best practices configuration for compliance to standards such as 21 CFR Part 820 and ISO 13485. Design engineers can remain in their native CAD environments and still share vital product specifications with the rest of the organization. By providing electronic workflows and instant access to supporting documentation, MasterControl also reduces the overall cost of MRB.

MasterControl automates quality events such as CAPA, customer complaints, eMDRs, NCMRs, and audits with electronic signatures and workflows. Also, employee training records can be automatically maintained and controlled with robust links to the MasterControl document management system.

Medical device companies can make efficiency and compliance synonymous throughout the enterprise with tools that make product development and quality more efficient.

Quality professionals achieve compliance without hindering the development cycle while at the same time increasing overall product quality by incorporating quality feedback into future design
Access to all supplier-related quality information is available from a single interface, which allows for rapid assessment and monitoring
Supplier compliance is insured by MasterControl's automated status tracking functionality
Regulatory specialists are able to participate in the development cycle and can easily repurpose documentation for use in regulatory submissions

Integrated Enterprise System:

MasterControl serves as a single source for product definition, providing a central repository for all drawings, specs, manufacturing procedures, inspection criteria, marketing collaterals, bills of materials, etc.
The system features tightly integrated applications
MasterControl seamlessly integrates with the tools you use every day: CAD, Outlook, Word, MS Project, etc.

Advantages of MasterControl Medical Device Software System

MasterControl's advanced document control functionality is more conducive to streamlining processes throughout the enterprise. Users from any department can easily collaborate on the same document using the applications with which they are most comfortable. The system streamlines supply chain management to help prevent receiving delays, product rework, and scrapping of product. MasterControl also provides an overview of the development pipeline, ensuring that purchasing decisions are based on accurate data. By reducing bottlenecks and inefficiencies across multiple departments, MasterControl reduces the total amount of time it takes to get your product to market while simultaneously enhancing product quality and regulatory compliance.