Speaker Profile
Nellie Bushman
As a seasoned professional with over 20 years of experience in the medical device industry, Nellie Bushman has established herself as a trusted expert in Quality Management Systems (QMS). Her extensive experience includes managing, streamlining, and implementing QMS for small, medium, and large companies. In 2014, she began consulting with small startups, preparing them for commercial launch by implementing and managing QMS. Now in 2022, she has established BushmanQC Virtual Quality Management System (VQMS), further expanding her reach and expertise in the field. Nellie's passion for quality is evident in her certifications as an ASQ Auditor since 2003 and as an MDSAP/ISO Internal Auditor. She has a bachelor's degree in business management from the University of Phoenix. Nellie's goal is to provide value through easy-to-use quality processes and implementing VQMS for small startups.
Nellie Bushman
May 10 2024
01 : 00 PM EST
60 Minutes
When does a Medical Device Start up need a Quality Management System
As a startup developing a medical device, implementing a Quality Management System (QMS) is not just a good practice but a regulatory requirement in many jurisdictions. A QMS is crucial for ensuring that your medical device meets regulatory standards, operates safely, and delivers effective results to patients. Here's why and when you should start implementing and using a QMS:Regulatory Compliance: Regulato..
Nellie Bushman
June 17 2024
01 : 00 PM EST
60 Minutes
Performing Virtual Internal Audits
Conducting a virtual internal audit has become increasingly common in today's digital age, especially with the widespread adoption of remote work and technological advancements. While traditional audits involve physical presence and face-to-face interactions, virtual audits leverage digital tools and platforms to achieve similar objectives efficiently. Whether due to pandemic-related restrictions or the nee..
Nellie Bushman
July 17 2024
01 : 00 PM EST
60 Minutes
Modernizing Lab Notebooks
In the realm of scientific research, the documentation of experiments and observations is not only a crucial aspect but often a regulatory requirement. Traditionally, this documentation has been done through physical lab notebooks, serving as a tangible repository of scientific endeavors. However, as technology advances, the landscape of lab documentation is evolving rapidly. In a recent seminar titled "Mod..