Ms. Nancy Knettell

Area Of Expertise : Medical Device Software 510K Medical Device Software V+V Software 510K Medical Device 510K Software Regulatory Medical Device Software Verification and Validation
30 Years Of Experience
Training Industry : Life Sciences

Founder and Principle, SoftwareCyber510K, LLC

Nancy Knettell, Founder and Principle of SoftwareCyber510K, LLC has over 30 years in Regulatory, Software Development, and Systems Engineering experience primarily in the Medical Device industry consulting to major Medical Device and IVD companies such as Cook Medical, Johnson and Johnson, ThermoFisher Scientific, Smith and Nephew, and Genomic Health.

Involvement for Nancy, in 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 others facing such life threatening events by advancing the potential for life-saving medical devices through the use of quality based software engineering systems.

4 results Found
Recorded Webinar

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. One of the biggest risks most company's face when submitti ...

  • Basic & Intermediate
  • 60 Mins
Recorded Webinar

Medical Device Software Verification and Validation

This webinar will teach you how to design, build and test medical device software in preparation for the successful 510k submissions. It will cover medical device software user requirements, software architecture, design, unit testing and m ...

  • Basic & Intermediate
  • 60 Mins
On-Demand Webinar

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. One of the biggest risks most company's face when submitti ...

  • Basic & Advanced
  • 60 Mins
Recorded Webinar

Medical Device Software: Verification, Validation & Compliance

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 510K approval. One of the biggest risks most company's face when submitting their ...

  • Basic & Advanced
  • 60 Mins