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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.
2 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 submitting their device for ...
- Basic & Intermediate
- 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 device for approval ...
- Basic & Advanced
- 60 Mins