Today FDA issued a final guidance, “Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program. Guidance for Industry and Food and Drug Administration Staff Document (May 7, 2019). The FDA’s Q-Submission Program provides submitters an opportunity to have early collaboration and discussions about medical device submissions. In our opinion, early feedback and...Read More
A 2015 article providing a review of the factors that contribute to a potentially insecure environment, together with the identification of the vulnerabilities, and why these vulnerabilities persist and what the solution space should look like.Read More
Company: Viewray, Inc. Date of Enforcement Report: 5/8/2019 Class II PRODUCT MRIdian Linac Radiation Therapy System, Model 20000. Recall Number: Z-1251-2019 REASON A discrepancy between optimization and planning forward dose calculation between adaptive optimizations and AQA dose calculations can occur. RECALLING FIRM/MANUFACTURER Viewray, Inc on 3/18/2019. Voluntary: Firm Initiated recall is ongoing. VOLUME OF PRODUCT...Read More
Company: Siemens Medical Solutions USA, Inc. Date of Enforcement Report: 5/8/2019 Class II PRODUCT SOMATOM Definition Edge, Model Number 10590000 Product Usage: Computed tomography systems intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. Recall Number: Z-1245-2019 SOMATOM Edge Plus, Model Number 10267000 Recall Number: Z-1246-2019 SOMATOM Definition...Read More
Do you have gaps with IEC 62304 compliance or with FDA expectations for software verification? We can help you quickly remediate gaps with unit verification including unit testing, code review, and static analysis, as well as integration and system verification testing. Call us at 781-721-2921 or email firstname.lastname@example.org to start a conversation. We can provide estimates of cost and support your development tools.