March 8, 2017
Company:Medtronic Neuromodulation Date of Enforcement Report 3/8/2017 Class l PRODUCT Medtronic SynchroMed II Implantable Drug Infusion System. This system includes: Model 8870 Software Application Card, Model 8840 N’Vision Clinician Programmer, and Model 8637 SynchroMed II Implantable Drug Infusion Pump (supplied in 20 ml or 40 ml reservoir size.) Recall Number Z-0788-2017 REASON Medtronic is following...
Read More
Company: Mckesson Medical Imaging Date of Enforcement Report 3/8/2017 Class lI: PRODUCT McKesson Radiology 12.2 – Picture Archive Communication System (PACS). Recall Number Z-1245-2017 REASON Issue for customers that use an EMR login or legacy web URL login or legacy web URL login for McKesson Radiology PACS that may result in missing images in a...
Read More

62304 Software Training Course – February 23-25, 2021

IEC 62304 and Emerging Standards and FDA Expectations for Medical Device and Health IT Software – Virtual

This very popular 3-day course provides a clear understanding of applying IEC 62304 standard for medical device software and much more. The course compares and contrasts 62304 with FDA expectations and discusses approaches for alignment. In addition, participants will learn of other relevant standards and technical reports pertinent to medical device software, HealthIT, medical mobile apps, and Software as a Medical Device (SaMD) products (e.g., 82304, 80002-1, 14971, 80001-2-x, 62366).

Participants will gain practical advice and pragmatic experience with all types of medical software. Participants will leave with a clear understanding of how to effectively and efficiently integrate 62304 compliance into their software development lifecycle (SDLC).

Register (click):  EventZilla Registration Site

Need info?  Email us at

Corporate Office

15148 Springview St
Tampa, FL 33624
Partners located in the US (CA, FL, MA, MN) and Italy.