Ashley Kelleher

Senior Medical Device Consultant, Medical Devices and IVDs at NSF, USA

Speaker

Ashley Kelleher has more than 14 years of professional experience in the medical device, pharmaceutical and certification industries. Her experience includes program management, project management and implementation of global, certification body and notified body accreditations to the ISO 13485, ISO 9001, ISO 15378 and ISO 14971 standards; GDP/GMP/GLP requirements; as well as MDSAP, EU 2017/745, MEDDEV 2.7/1 rev. 4 and relevant MDCG guidelines. Throughout her career, Ashley has developed several standardized interpretation trainings for ISO standards, state and federal regulations for external assessors and certification body personnel, that worked for the medical device, diagnostic and pharmaceutical sectors.

Ashley joined NSF in May 2022, as a Senior Consultant for Medical Devices/IVDs and is responsible for client engagements, consultation, implementation and optimization of quality management systems, submissions for technical file documentation, risk management, regulatory submissions and training. Ashley’s educational background is focused on Veterinary Science. She completed further training programs in order to broaden her expertise and holds lead auditor certifications for ISO 13485, GDP, MDSAP, EU-MDR, ISO 14971, ISO 9001 and ISO 15378.

Areas of expertise:

• Regulatory Affairs
• Technical Documentation
• EU Medical Device Regulation (MDR)
• Risk Management
• Training
• Quality Management Systems
• Audits & Inspections
• MDSAP, ISO 13485:2016, ISO 15378:2017, ISO 9001:2015, GDP, GMP, GLP, ISO 14971:2019, EU 2017/745