Speaker Profile

Nancy
Nancy Knettell
Founder and Principal , SoftwareCyber510k,LLC,

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.

For Nancy, involvement in diagnostic and medical device development is a personal issue as well. Having lost her father at an early age to heart disease, she now wants to work to help other people facing such life threatening events. It is her mission to advance the potential for life-saving medical devices through the use of quality based engineering systems.

Upcoming Webinars Recorded Webinars
  • 11
  • December
  • 2019
  • Wednesday
10:00 AM PST | 01:00 PM EST

EN/IEC 62304 - Is your Medical Device Software Out of Compliance

This course is essential for Medical Device and IVD companies interested in submitting software enabled medical Devices or Software as a Medical Device to the FDA for 510K approval.

Nancy Knettell Nancy Knettell | Duration:90 Minutes | Price: $150.00 | View Details
Nancy Knettell

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

This course is essential for IVD Medical Device companies interested in ensuring their software enabled medical Devices or Software as an IVD Medical Device is compliant to the new Software requirements in the IVDR 2022 regulations avoiding revenue interruptions that can result from failed unannounced audits.

Speaker: Nancy Knettell | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Nancy Knettell

EN/IEC 62304 - Is your Medical Device Software Out of Compliance

This course is essential for Medical Device and IVD companies interested in submitting software enabled medical Devices or Software as a Medical Device to the FDA for 510K approval.

Speaker: Nancy Knettell | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Nancy Knettell

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

This course is essential for IVD Medical Device companies interested in ensuring their software enabled medical Devices or Software as an IVD Medical Device is compliant to the new Software requirements in the IVDR 2022 regulations avoiding revenue interruptions that can result from failed unannounced audits.

Speaker: Nancy Knettell | View Anytime | Duration: 60 Minutes | Price: $390.00 | View Details
Nancy Knettell

EN/IEC 62304 - Is your Medical Device Software Out of Compliance

This course is essential for Medical Device and IVD companies interested in submitting software enabled medical Devices or Software as a Medical Device to the FDA for 510K approval.

Speaker: Nancy Knettell | View Anytime | Duration: 90 Minutes | Price: $390.00 | View Details