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Empowering Innovators in Medical Device Design

Organizing Design Projects

Product development teams are often comprised of employees, suppliers, contract manufacturers, end users and outside consultants with each playing a key role in developing and validating new products. Controlling access and managing each stakeholder’s responsibilities and authority gives you greater control over the design process and enables you to adjust resource allocations where necessary.

Onshape offers strict, role-based access to keep your design data secure at all times. Every person requiring access must first be invited with specific permissions to view or edit your data. Keeping track of the status of each project is easy with Onshape’s reports and analytics, giving you unprecedented visibility into your design processes and your overall effectiveness.

Change Control

Design reviews and verification activities often uncover errors or omissions that require design changes. Corrective and preventive actions sometimes fix one set of issues, while inadvertently causing others, so it’s important to carefully manage the change control process and to document and communicate all changes to all stakeholders.

Onshape’s built-in data management enables design teams, spread across multiple locations, to work on the same design at the same time. Corrective and preventive actions can be implemented in a dedicated branch, so your team can experiment with design ideas without affecting each other's work. Errors and unsatisfactory design changes are easily undone, while the best ideas can be merged with the main design.

Design History

Design decisions are made all the time. These decisions can directly affect device users and patients, so it’s critical to maintain an easily accessible design history about each device. Unless every decision is recorded and documented, there’s no way to know when and why a detail was changed or who changed it.

Onshape’s unique database architecture captures and records every edit made by every engineer for the lifetime of a project. Your designs are always up to date and no data is ever lost or destroyed. Onshape’s comprehensive edit history gives you complete insight into who made each design change and when.

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