Speaker Profile


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.

  •  Wednesday, November 13, 2019
  • 10:00 AM PST | 01:00 PM EST,
  • 60 Minutes
  • $150.00
Is your Software 510k Ready

This course is essential for Medical Device companies interested in submitting software enabled medical Devices or Software as a Medical Device to the FDA for 510(k) approval. One of the biggest risks most company's face when submitting their device for approval is finding out after seven or more months of waiting that the 510(k) has been denied because the software portion of the submission is inadequate and not compliant.

  •  Monday, November 25, 2019
  • 10:00 AM PST | 01:00 PM EST,
  • 60 Minutes
  • $150.00
Medical Device Software Verification Validation

This course is essential for Medical Device companies interested in submitting software enabled medical Devices or Software as a Medical Device to the FDA for 510(k) regulatory approval. One of the biggest risks most company's face when submitting their device for approval is finding out after as many as seven or more months post filing that the 510(k) has been denied because the software portion of the submission is inadequate and not compliant.

  •  Wednesday, December 4, 2019
  • 10:00 AM PST | 01:00 PM EST,
  • 60 Minutes
  • $150.00
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.

  •  Wednesday, December 11, 2019
  • 10:00 AM PST | 01:00 PM EST,
  • 90 Minutes
  • $150.00
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.

View All



  • Recorded
  • View Anytime
  • 60 Minutes
  • $190.00
Is your Software 510k Ready

This course is essential for Medical Device companies interested in submitting software enabled medical Devices or Software as a Medical Device to the FDA for 510(k) approval. One of the biggest risks most company's face when submitting their device for approval is finding out after seven or more months of waiting that the 510(k) has been denied because the software portion of the submission is inadequate and not compliant.

  • Recorded
  • View Anytime
  • 60 Minutes
  • $190.00
Medical Device Software Verification Validation

This course is essential for Medical Device companies interested in submitting software enabled medical Devices or Software as a Medical Device to the FDA for 510(k) regulatory approval. One of the biggest risks most company's face when submitting their device for approval is finding out after as many as seven or more months post filing that the 510(k) has been denied because the software portion of the submission is inadequate and not compliant.

  • Recorded
  • View Anytime
  • 60 Minutes
  • $190.00
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.

  • Recorded
  • View Anytime
  • 90 Minutes
  • $190.00
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.

View All

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Contact Us

NetZealous LLC,
39658 Mission Boulevard, Fremont,
CA 94539, USA.

Information

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  +1-800-447-9407
  Fax: 302 288 6884
  support@compliance4All.com