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Intelligent Design Control

Complexity in the development of medical devices, especially for smart medical devices that include software and electronics, demands software solutions to establish design controls that orchestrate the design process across inter-disciplinary engineering teams. Intelligent Design Control is our solution for medical device companies to become data-driven, model-based, and document smart. Intelligent Design Control increases engineering efficiency and speed across the device lifecycle while avoiding costly errors, quality issues, and recalls.

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Intelligent Design Control

Complexity in the development of medical devices, especially for smart medical devices that include software and electronics, demands software solutions to establish design controls that orchestrate the design process across inter-disciplinary engineering teams. Intelligent Design Control is our solution for medical device companies to become data-driven, model-based, and document smart. Intelligent Design Control increases engineering efficiency and speed across the device lifecycle while avoiding costly errors, quality issues, and recalls.

Client Successes

Learn how our customers benefit from this solution.

Sirona Dental Systems

Our solutions unified an end-to-end platform to establish traceability to prove compliance, simplicity, and cost effectiveness.

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Creators of Leading Neuromodulation Devices

Quality, risk, and compliance are critical to achieving project objectives during first-time testing.

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Cercacor

Cercacor

Our solutions helped reduce test creation time by up to 75 percent.

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Design Process for Medical Devices

Video highlighting the significance of digitalization and the design process for medical device manufacturers.
Intelligent Design Control for Medical Devices

On-Demand Webinar

Learn about mitigating risk and optimizing design.

This on-demand webinar addresses many of the issues currently facing the medical device industry and how our digital solutions can help companies overcome these challenges.

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Report: Intelligent Design Control

The development of modern, complex medical devices is a big challenge, especially for smart medical devices which increasingly use software and electronics to deliver essential therapeutic and diagnostic capabilities. Establishing regulatory-mandated design controls, by tracking and tracing the network of user needs, risks, design requirements, and verification/validation testing can become overwhelming without the use of software-based solutions. The risk of incomplete, incorrect data can lead to errors, quality issues, loss of time, poor performance, and significantly increase the likelihood for recalls. Intelligent Design Control is our holistic solution for integrating requirements and risk management, test planning and execution, and design output management, including Design History Files (DHF) and Device Master Records (DMR). Enable your medical device company to become data-driven and document smart by powering your design process across mechanical, electrical, and software engineering teams with increased efficiency, speed and clarity to produce safe, high quality device designs. Furthermore, our solutions support devices throughout the entire lifecycle by re-using data and connecting it via digital threads to quickly respond to inquiries during regulatory reviews, or sustaining incremental engineering changes.

How to Achieve Compliance
Offering easy-to-use, industry-proven processes for optimum device design control Access Report

Whitepaper: Medical Device Design Control

Medical device product development is a highly integrated and regulated process. Implementation of solution-based requirements tracking requires attention to a variety of nuanced topics.When presented with the task of tracking the many conceptual relationships in a project of this type, the initial software solution of choice tends to be traditional two-dimensional text systems. This paper outlines why our digital enterprise solution is the best option for your medical device organization.

Medical Device Design Control
Our solutions represent a platform designed to model process relationships and provide a multidimensional, live-linked database for today’s complex development environments. Access Whitepaper

Solution Capabilities

Explore the key areas of this solution.

Program and Project Management

Program and Project Management

Manage and execute medical device design projects via a unified digital platform.

Materials Data & Lifecycle Management

Materials Data & Lifecycle Management

Material information and how it’s managed can have a profound effect on your product’s lifecycle, and materials data management often plays a role in the success of the product.

Manufacturing Execution Management

Manufacturing Execution Management

Maximize profit margins by simultaneously increasing revenues and decreasing costs – launching you to new levels of growth and profitability.

Requirements Management

Requirements Management

Capture and communicate requirements with an integrated platform designed specifically for medical device organizations.

Risk Management

Risk Management

Manage risk and eliminate the likelihood of errors and product recalls with early-stage issue detection and complete traceability.

Test Case Management

Test Case Management

Create and manage test cases and link them to their corresponding work items such as requirements, change requests or other test cases.

Document Control

Document Control

Avoid copy mistakes, ensure integrity of data, manage medical device records and provide traceability across entire device lifecycle.

Design Output Management

Design Output Management

Enable companies to efficiently synchronize all data, domains and functional areas, including secure supplier collaboration. Provide a scalable, best-in-class platform for integrating outputs from all engineering disciplines.

DHF, DMR & Technical File Management

DHF, DMR & Technical File Management

Execute phased design processes from feasibility studies through to production, service and support, including lifecycle change management. Create and maintain DHF and DMR records, and manage the design transfer process.

Verification & Validation (V&V)

Verification & Validation (V&V)

Integrate digital simulation in design and manufacturing processes to provide digital evidence for verification and validation.

Digital Enterprise for Medical Devices

Digital Enterprise for Medical Devices

Optimize the entire value chain through the use of digital twins, virtual representations of the device and its manufacturing processes.