In the rapidly evolving global medical device industry, a company’s ability to bring an innovative and cost-effective product to market quickly is dictated by how well they manage their design and development processes.
Despite the digital era, many medical device companies are still plagued by manual 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 product development, complex quality assurance and proof of compliance using browser-based, regulatory-compliant software systems such as Polarion ALM and Jama Connect that help you track project artifacts electronically and allow you to create a sustainable digital twin.
When you partner with Sterling PLM, we will help you with adopting an electronic system such as Polarion ALM or Jama Connect which will enable you with:
Effective Requirements management: Using a requirement management system will transform the way you capture, analyze, and manage your requirements. Modern requirement management systems provide a centralized repository where requirements can be stored, organized, and accessed by all stakeholders in real-time. Through features such as version control and active collaboration, electronic systems enable seamless communication amongst cross-functional project teams. Leveraging electronic systems for requirements management will enhance efficiency, accuracy, and transparency, leading to successful project outcomes.
Digital Traceability: The medical device product development 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. Systems such as Polarion ALM and Jama Connect eliminate that burden by linking project artifacts electronically and showing the traceability matrix in easily configurable reports that ensure coverage, transparency, and adherence to the regulatory standard.
Electronic Approvals: With multiple disciplines involved in reviews and managing approvals, ensuring that everyone is on the same page can be daunting—particularly if any changes are made. Polarion ALM and Jama Connect serve as a single source of truth that will help your team to navigate the interconnected web of project artifacts. These systems facilitate a smoother approval process, greater accuracy, and shorter review cycles to ensure a project is delivered on time and on budget all while staying compliant with FDA CFR Part 11.
Regulatory compliance: Ensuring compliance with ISO 13485 is not a nice-to-have; it’s a must-have. If done manually, you need a constant manual oversight to ensure regulations are being satisfied. Polarion ALM and Jama Connect simplify this process for you. With the ability to embed regulatory requirements into templates, these systems will let you link standards to specific procedures or product requirements to ensure you satisfy all regulations. Plus, they 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.
Audit trails: In the development of intricate medical devices, the significance of audit trails cannot be understated. The presence of effective audit trails ensures swift and precise retrieval of required data when auditors request information. By utilizing Polarion ALM and Jama Connect, you can seamlessly track and record changes throughout the development process, capturing crucial details such as the nature of the change, the responsible individual, and the timing of the modification, all while preserving a comprehensive version history. This empowers you to access the necessary data promptly and effortlessly whenever the need arises.
To learn more about Requirement Management systems and their role in effectively managing the product development, contact our team today.
March 29, 2021
October 18, 2023