Software has evolved to become the key differentiator for medical device manufacturers, even though there are continued challenges.
The use of a unified application lifecycle management (ALM) solution, such as Polarion ALM, accelerates innovation while at the same time streamlining quality assurance and automating proof of compliance.
Despite the benefits of software innovation for medical devices, there are a number of strict quality requirements, product failure risks, and even more regulatory complexity.
Benefits Polarion ALM provides:
Automate risk management and compliance Quick-start with automated industry processes Synchronize collaboration in real-time Automate validation and verification
Validation and verification (V&V) is a challenge that all medical device manufacturers must meet - and our solutions provide comprehensive traceability, automated forensic-level accountability, and real-time reporting throughout the project lifecycle. As previously noted in a blog post, Polarion solutions are well suited for onboarding for FDA “Automated Processes,” listed in 21 CFR §820.70(i).
As more medical devices receive connectivity, there are new risks that must be addressed. Some manufacturers have spoken publicly about why connectivity is important, despite the risks, as it can provide better patient diagnosis, monitoring and prevention, and other great benefits.
However, the FDA must create new guidelines - while working with technology creators and device manufacturers - as future approval may be even more complicated.
To learn more, please view the “Cybersecurity Risks to Avoid When Developing a Medical Device” on-demand webinar by clicking the following banner:
To make things easier, customers are able to make use of compliant electronic signature functionality for FDA 21 CFR Part 11, with compliance for FDA 21 CFR Part 820, IEC 62304, and other government regulations.
Polarion ALM provides a 100% browser-based solution that increases real-time collaboration among workers.