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Ensure Compliance and Control

Use PLM for medical device manufacturing to streamline product development and simplify compliance while providing innovative solutions.

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Industry Challenges

In the highly regulated and rapidly evolving medical engineering industry, precision, innovation, and unwavering adherence to stringent regulations are not merely goals but prerequisites for success. To meet these critical demands, an integrated suite of medical device manufacturing software solutions is indispensable. Our offering, centered around PRO.FILE PLM, is meticulously tailored to address the unique needs of medical device manufacturers and engineering firms, ensuring both compliance and operational excellence.

Meet Requirements with Medical Device Manufacturing Software

The core challenge in medical device manufacturing lies in ensuring and thoroughly documenting compliance with industry standards, notably FDA Title 21 CFR Part 11. PRO.FILE, our advanced Product Lifecycle Management (PLM) solution, is engineered to automate numerous compliance-related tasks, significantly easing the burden of regulatory adherence. This powerful medical device manufacturing software empowers organizations.

Centralize Data Management

PRO.FILE provides a single, unified repository for all product-related data, from design specifications and material lists to testing protocols and regulatory submissions. This centralization is crucial for maintaining data integrity and accessibility, which are vital for audits and product traceability within the medical device lifecycle.
  • Single Source: Unified data
  • Audit Readiness: Traceable information
  • Data Integrity: Reliable records
Close-up of biomedical devices, including a monitor displaying vital signs and a ventilator with attached tubes and controls, in a clinical setting.
Woman in business attire holding a laptop and smiling, while two colleagues discuss HVAC equipment manufacturers CPQ solutions at a conference table in the background.

Maintain Visibility and Control with Document Management

Through its seamless integration with DMS (our robust Document Management System), PRO.FILE ensures unparalleled visibility and precise control over the exchange of all project documents. This robust document management capability within the medical device manufacturing software suite promotes consistency, reduces errors, and establishes dependability across all stages of product development and manufacturing. This is especially critical for controlling design history files (DHF) and device master records (DMR).
  • Version Control: Controlled documents
  • Process Transparency: Clear oversight
  • Error Reduction: Minimized mistakes

Implement Robust Change Tracking and Audit Trails

The ability to track every change and access comprehensive audit trails is non-negotiable in medical device manufacturing. PRO.FILE implements robust, system-based audit trails that automatically log modifications, user actions, and timestamps. These invaluable records provide an indisputable historical account, essential for regulatory submissions, quality control, and future reference.
  • Full Accountability: User actions
  • Historical Records: Indisputable log
  • Regulatory Compliance: Audit-proof
A modern, empty operating room with a surgical table and bright overhead lights showcases the precision work of biomedical and clinical engineers, as various medical equipment is meticulously arranged around the room.
Four professionals in business attire discuss around a glass table with papers as one man stands and speaks, possibly explaining what is B2B and B2C. A presentation with a bar graph is visible in the background.

Automate Compliance Processes and Workflows

Leveraging DMS, our medical device manufacturing software solution automates critical processes. It seamlessly creates structured file folders necessary for obtaining approvals and standardizes the electronic documentation of digital signatures and workflows. This automation streamlines the approval process, minimizes manual errors, and ensures that every step adheres to established regulatory procedures, fostering a consistent and compliant manufacturing environment.
  • Streamlined Approvals: Faster processes
  • Reduced Manual Effort: Efficiency gains
  • Consistent Procedures: Standardized workflows

Summary

By integrating PRO.FILE PLM as a foundational component of your medical device manufacturing software strategy, companies can navigate the complexities of regulatory compliance with greater confidence, accelerate product development cycles, and ultimately bring safer, more innovative medical devices to market.

We are a technology-driven company and for us, DMS is the perfect approach to embrace the digitalization of document-heavy business processes. More so than any other vendor, PRO.FILE was able to meet all of our requirements.”

Marius Schönberger
Head of IT, Medtron AG

Medtron AG

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