ISO 14971:2019 - Overview and Applicability to EU MDR and other regions
11:50 AM - 1:00 PMMon
Speakers
Edwin Bills
ELB Consulting
• ISO 14971:2019 vs. EN ISO 14971:2019 and applicability
• Present EN ISO 14971:2019 and changes from 2012 edition
• Future Amendment for Z Annex
• Application of EN ISO 14971:2019 to MDR / IVDR