Software is an important part of emerging medical devices, but there is a growing list of potential risks that manufacturers must address.
Software has become the differentiator for medical devices, with customers facing audit findings, product recalls, delays in product release, and other key challenges. During the webinar, you'll hear from Laurence Sampson, Siemens PLM Industry Expert for Medical Devices and Life Sciences, as he explains how unified ALM helps your organization address software challenges.
To view the webinar, please click the following link:
In addition, Polarion ALM provides the following benefits:
Self-auditing risk management and compliance
Quick-start with automated industry processes
Self-auditing Validation and Verification (V&V)
If your team needs to meet FDA 21 CRF Part 11, FDA 21 CFR Part 820, IEC 62304, and other government compliance standards - Polarion ALM streamlines achieving traceability from FMEA and mitigating requirements designs all the way to test cases and requirements verification.
Your team can bridge the gap between development, assurance, and proof of compliance - especially as more decision makers cautiously research Internet of Things (IoT) connectivity.
As medical device manufacturers develop medical devices with IoT connectivity, hospitals, patients, and medical professionals must be comfortable working in these new environments.
If you would like to learn more, the “Cybersecurity Risks to Avoid When Developing a Medical Device” on-demand webinar will be a valuable resource.