WHO BENEFITSReliable, auditable, secure, traceable, and easily accessible Design History File (DHF) and Design Master Records (DMR) organized according to your Design Control processes. All within your Quality System Framework.

Establish and maintain your DHF and DMR in Arena to enable regulatory compliance and streamline audits.

Design History File (DHF)

The DHF contains detailed documentation of the evolution of your product through the design and manufacturing process. It is a core part of medical device compliance. The DHF captures the complete record of your design decisions from the planning phase to production.

When you organize your DHF, Arena PLMs project functionality helps you track your Design Control elements and deliverables. The key elements of Design Control are design and development planning, design input, design output, design review, design verication, design validation, design transfer, and design changes. Arena PLMs document control and change management functionality allows you to properly manage product design and changes, and record each key decision. It also provides required document and change history.

Document Control and Project Management Track your deliverables and manage DHF and DMR using Arena PLM according to your Design Control and Document Control processes. Your documents and product records will be connected to Design Control elements in a secure yet accessible way. This solution supports cross functional collaboration which improves time to market, shortens cycle times, and reduces cost all while maintaining compliance. Audits are simplied with online searching, traceable documents, product records, and change history.

Quality Management Create new DHF based on templates that adhere to your Standard Operating Procedures. These templates include elements all named according to your Quality System processes. By using Arena PLM to manage DHF and DMR, you can streamline compliance and easily demonstrate that you are meeting your Quality System requirements.

Management Gain insight and visibility into project status. Evaluate the status and monitor progress of Design Control deliverables. Ensure that all relevant partiesincluding suppliersare in accord and up to speed on a given project. Improve processes iteratively to shrink time to market and increase company-wide eciency. Continuously improve team productivity.

An accessible, secure DHF and DMR enables compliance, shortens audit time, leads to higher quality product with less administrative overhead.

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Figure 1: Design History File (DHF) in Arena PLM

Arena PLMMeet your DHF and DMR Requirements

Device Master Record (DMR)

The DMR captures every part, drawing, document, work instruction and processing instruction related to your medical device. This is also a key element of medical device compliance.

Our BOM Management functionality is designed for precisely this purpose, creating a clear and consistent product record with robust version control that is centralized and accessible as needed, rather than distributed across your supply chain and engineering team.

2016 Arena Solutions. All rights reserved.

Auditors appreciate that all documents, product records, and quality records are linked and traced.

Figure 2: Device Master Record (DMR) in Arena PLM

Figure 3: Design History File (DHF) is linked to Device Master Record (DMR) from Figure 2 (above) - highlighted in yellow (below).

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Arena PLMMeet your DHF and DMR Requirements