ComplianceOnline

Expert Profile


Mary Nunnally
President, Translational Medicine LLC

Mary H Nunnally, PhD, is an experienced Quality and Operations Executive (20+ years) within the medical device, biomedical research product, veterinary medicine and pharmaceutical industries. She has an extensive hands-on experience in the establishment and maintenance of US FDA 21CFR 820, ISO 13485 and ISO 9001certified Quality Systems, including implementation of all systems required for compliance with US, CMDR, and EU regulatory statutes.

Trainings by Expert

How to Establish and Maintain a Design History File for a Medical Device
Category: Medical Devices , GXP Medical Devices , Marketing and Promotion , Audits & Inspections , QMS, ISO 13485, CAPA , Supply Chain and Manufacturing , R & D , Audit & Inspection-Role , Quality Audit , Medical Device Inspection , Research & Development , Device R & D , Regulations & Guidances , Life Sciences , Regulatory Affairs , Documentation and Data Management

Develop a Device Master Record that can assist with Device History Record Review
Category: Drugs and Chemicals (Pharma) , Medical Devices , Risk Management , Audits & Inspections , QMS, ISO 13485, CAPA , Documentation and Policy Management , Lifescience process & Procedures , Life sciences QA/QC , Regulations & Guidances , Life Sciences , Regulatory Affairs , Documentation and Data Management , QA/QC