Please do not close or refresh this window...
Tuesday, 19 October 2021 8:30 AM - Thursday, 21 October 2021 4:30 PM EDT
Access code applied successfully. Remove
Invalid access code. Try again
Valid for one person to join via Zoom on Oct 19-21, 2021, 8:30 am to 4:30 pm EDT. Students required to use camera at many points during the training. No recording allowed. Refunds minus credit card fees through September 1, 2021. Substitutions allowed after that. For registrations of 3 or more, get a $400 discount per student.
This three-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).
https://www.softwarecpr.com
SoftwareCPR® provides full service regulatory compliance and premarket submissions support for Medical Device Manufacturers including quality systems development, risk management - including for Health IT and Standalone Software, Human Factors and usability engineering, as well as hands-on validation services for Pharmaceutical and Medical Device companies. We also have extensive experience related to FDA enforcement action representation and negotiation and have served as expert witnesses.
Brian has over 35 years in the medical device industry as a biomedical and software engineer, various levels of management in medical device companies, and now is a Partner and General Manager of SoftwareCPR®. Brian has taught software validation courses at FDA, for AAMI, and both public and private courses for SoftwareCPR®. Brian helped create both AAMI TIR32 and AAMI TIR45 is a member of the UL Standards Technical Panel 5500, Remote Software Updates.
Integer nulla lorem, pellentesque eget eros malesuada, semper bibendum felis. Proin quis est egestas, ultrices purus tempor, aliquet erat. Nullam molestie, neque at hendrerit semper, dui lacus eleifend arcu, quis mattis augue leo condimentum dui. Nunc vehicula eleifend risus vitae luctus. Sed sed sem nibh. Nam sit amet massa ullamcorper, iaculis felis id, ullamcorper libero. Aenean aliquet orci quis nisi interdum faucibus. Maecenas sollicitudin, nunc vitae tempus feugiat, arcu elit egestas diam, sit amet maximus neque turpis ac quam. Curabitur at ligula eget turpis pellentesque vestibulum eu id ante. Cras eget turpis mauris. Vestibulum vitae quam elit. Suspendisse bibendum at ipsum nec tempor. Ut in tristique nibh. Aliquam erat volutpat. In hac habitasse platea dictumst.
Vivamus tempor viverra enim, commodo faucibus quam porta sed. Sed et varius nunc. Fusce cursus sem nec tellus accumsan, sed laoreet nisi vulputate. Praesent varius quis turpis in aliquam. Phasellus nisl velit, porttitor eget risus sed, interdum elementum nibh. Praesent eget ante bibendum quam suscipit accumsan sit amet eu nisi. Ut eget facilisis risus. Proin molestie lorem ut interdum finibus. Sed pretium ut sapien at dictum. Sed sit amet dolor tincidunt turpis tincidunt ultricies et et neque.
Nam non augue a lorem tempor sodales. Vestibulum ante ipsum primis in faucibus orci luctus et ultrices posuere cubilia Curae; Quisque ullamcorper lobortis rhoncus. Morbi nec dui vitae odio ultricies posuere ac nec turpis. Vestibulum efficitur lectus sem, sed volutpat quam congue at. Nulla quis aliquam ex. Vestibulum eget felis consectetur, efficitur risus non, dapibus tellus. Aliquam ac gravida dui. Donec vel est a arcu tristique egestas id vitae neque. Nullam varius odio eget leo porttitor, pharetra rhoncus quam dignissim..
Please enter below, the secure invite code provided to you by the event organizer in order to proceed...
(Please use a genuine email address. It will be used to validate your request)
