Despite the digital era, many medical device development companies are still plagued by manual medical device lifecycle management processes that eat up time and resources, drive up costs and put the company at risk for non-compliance with regulatory authorities.
At Sterling PLM, we’ll help you bridge the gap between fast-paced development, complex quality assurance and proof of compliance using Polarion software, a browser-based regulatory-compliant software program that helps you track project artifacts.
Efficient change management: In Polarion, you can quickly and easily review and manage changes without having to hunt down the hundreds or thousands of related project artifacts and documents manually. Polarion marks links for impact analysis as things change. You get a framework for systematic change management that identifies every location where a specific change must be made and manages that change through approval and implementation.
Audit trails: When developing a complex medical device, audit trails are critical. Auditors often require proof of audit trails during an audit of your QMS, and not every lifecycle management tool seamlessly chronicles them for you. Polarion tracks your changes as you work, recording what happened during the change, who made it, and when they did it, while preserving version history.
Traceability: The medical device product development lifecycle involves the daunting task of managing multiple requirements, test cases, risks and other project artifacts which are all interdependent. When traceability is done manually, it is time-consuming and prone to human error. Polarion removes that burden by connecting the dots showing the links between artifacts in easily configurable reports. Polarion makes it easy to confirm that each requirement is verified by a test case and the reports displayed are always up to date so users never have to worry about looking at obsolete information.
Documents and Approvals: With so many people involved in document reviews and managing approvals, ensuring that everyone is on the same page can be daunting—particularly if any changes are made. Polarion serves as a single source of truth that helps users navigate the interconnected web of project artifacts. Featuring a dashboard of approval status, statistics on progress and the ability to filter and hide items based on the artifacts most relevant to you, Polarian facilitates a smoother project flow, greater accuracy and shorter review cycles to ensure a project is delivered on time and on budget. The software also lets you easily assign specific reviewers, add comments related to disapprovals and easily view related project artifacts.
Regulatory compliance: Ensuring compliance with ISO 13485 is not a nice-to-have; it’s a must-have. If done manually, you need access to someone with intimate knowledge of the requirements standard who is ensuring regulations are being satisfied. Polarion simplifies this process for you. With the ability to embed regulatory requirements into templates, Polarion lets you link standards to specific procedures or product requirements to ensure you satisfy all regulations. Plus, Polarion will run trace reports to ensure testing has been completed or identify those requirements that haven’t been tested—all in a matter of seconds.
Version control configuration: Using Polarion will help you manage the configurations of each product and keep track of relationships across versions. Polarion lets you clearly identify everything that went into the design of a medical device and which elements appear in which version, without manually tracking it down.
For more information about Polarion and how it can help you manage your product development lifecycle, contact our team today.
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