Lezlie Hynes has over 30 years of experience in the fields of medical device, In Vitro Diagnostics (IVD), Human Cells, Tissues, and Cellular and Tissue-based Products (HCT/P) and hospital and reference laboratories. She has been with NAMSA since 2010, where she has gained experience working on various standards committees and working groups, in addition to partnering with international Clients—from small start-ups to large corporations—to develop and maintain quality systems and bring products to market. A special focus has been working with Sponsors to implement and validate computerized systems and assist in product development for Software as a Medical Device (SaMD) and Software in a Medical Device (SiMD) products.

Lezlie holds a Bachelor’s Degree in Medical Technology from the College of St. Scholastica in Duluth (Minnesota). In addition, she is a Member of the American Society of Quality (ASQ), American Society of Clinical Pathologists (ASCP) and Regulatory Affairs Professionals Society (RAPS). She is an active Member of the Software Standards Working Group from the Association for the Advancement of Medical Instrumentation (AAMI) and AFDO/RAPS Good Machine Learning Practices (GMLP) Working Group. She is an Exemplar Global Certified Lead Auditor ISO 13485:2016, ISO 19011:2018.

CORE COMPETENCIES

• Develops, manages and maintains operational Quality Management Systems (QMS)
• Conducts internal, supplier and third-party audits and QMS Gap Assessments measured against:

1. 21 CFR Parts 11, 50, 54, 58, 803, 806, 812, 820, 1271
2. ISO 13485:2016, 14971:2019, 14155:2020, 9001:2015, 19011:2018, 17025:2017
3. EU MDD, EU MDR and multiple country-specific regulations
4. IEC 62304 and 82304-1

• Supports Client FDA inspections and Notified Body assessments
• Provides GMP, QSR and inspection readiness training; conducts mock FDA inspections
• Assists Sponsors with remediation of audit and inspection findings
• Provides QMS support for regulatory submissions
• Conducts supplier qualifications and ongoing audits of Electronic Data Capture (EDC) system providers for clinical trials
• Implements and validates various computerized software systems, including Electronic Quality Management Systems (eQMS), labeling and SPC software, Electronic Trial Master File (eTMF) and SharePoint

RECENT PROJECTS

• Provided Quality System support for a Client’s successful PMA submission
• Assisted Sponsors with implementation and validation of eQMS software applications, meeting go-live date goals
• Provided on-site support for a large Client’s FDA inspection

PUBLICATIONS

• AAMI TIR45:2023 Guidance on the use of AGILE practices in the development of medical device software