Naghmeh joined Experien Group (now Veranex) in 2016 after spending 20+ years working in the medical device industry. Prior to her hire, Naghmeh served as the vice president of quality and/or regulatory affairs for four companies, and held management roles at both startups and established corporations. She is highly experienced with medical device software, including software as a medical device (SaMD). Naghmeh is an expert in the FDA’s Quality System Regulation 21 CFR Part 820, ISO 13485, EN ISO 14971, the European Medical Device Directive (MDD), the EU Active Implantable Medical Device Directive (AIMDD), and Health Canada’s CMDCAS for medical devices. She possesses ISO 13485:2016 Lead Auditor Certification from BSI.
At Veranex, Naghmeh works closely with companies’ technical teams. She helps companies generate device design history file (DHF) documentation for product development and is an expert in risk management, performance testing, electrical safety testing, and usability studies. Her additional functions include:
- Quality management system (QMS) implementation and/or documentation upgrade activities
- Quality representative responsibilities for phased design control, including support for risk management, Software Life Cycle Management, supplier quality, etc.
- Quality lead for client interface with external regulators (e.g., FDA and state of California Food and Drug Branch (FDB) inspectors, notified body auditors, etc.)
- Gap assessments, internal audits, supplier audits, and management reviews — as well as follow-up support to address findings as needed
- FDA and OUS regulatory submissions for premarket clinical testing and commercial clearances/approvals (e.g., IDEs, 510(k)s, de novos, technical files, design dossiers, etc.)
Past companies and experience
Naghmeh spent the first decade of her career at Siemens Medical Systems performing quality engineering for capital equipment product development. She has subsequently worked in a variety of product areas at different device companies, including Ventritex (implantable cardiac defibrillators), Aradigm (drug delivery combination product), Radiant Medical (systematic body cooling system), Health Hero Network (patient monitoring software), Asante Solutions (insulin pump system), and AirXpanders (breast tissue expander). She successfully obtained CE mark and U.S. and OUS clearance/approvals for numerous medical devices.
Naghmeh earned her B.S. in electrical engineering from Rutgers University and an M.S. in electrical engineering from New Jersey Institute of Technology in New Brunswick, New Jersey.