2019 - Software As a Medical Device (SaMD) New IVDR Document Requirements

Overview:
This course will ensure that IVD Diagnostic companies will know exactly what
documentation needs to be prepared for a 510(k) regulatory filing.
Why should you Attend:
They will also know how to ensure the documentation is prepared correctly
specifically for the software portion of the submittal so that it will comply
preventing delays of the 510(k) approval.
Areas Covered in the Session:
Ensure a faster 510(k) approval because the documentation is complete and
comprehensive
Prevent costly time to market issues because 510(k) has been rejected completely
because of software
Who Will Benefit:
IVD Medical Device Software Company Senior Management
IVD Medical Device Quality Engineers
IVD Medical Device Quality Senior Management
Speaker Profile:
Nancy Knettell , Founder and Principal at SoftwareCyber510, LLC, has over 30
years in Software Development and Regulatory experience primarily in the IVD
and Medical Device industry for such major IVD and medical device companies
such as Genomic Health, BioRAD, Smith and Nephew, Philips Medical, CR Bard,
Kollsman Medical, and Johnson and Johnson.
Event Fee: One Dial-in One Attendee Price: US $150.00
Contact Detail:
Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
Email: compliance4all14-AT-gmail.com