ISO 13485:2016 Pt 3 – Purchasing and Production Posted by Bob Duffy on June 12, 2019 in Device Tips, Regulatory & Standards Compliance EU, ISO 13485, Non-Conforming, Outsourcing, Process Validation, Purchasing, Quality Management System, Supplier View
ISO 13485, Part 2 Posted by Bob Duffy on January 26, 2019 in Device Tips, Regulatory & Standards Compliance Design, EU, ISO 13485, Medical Device File, Quality Management System, Risk Management View
CE Mark, Part 2, Conformity Assessment Pathways Posted by Bob Duffy on July 1, 2018 in Device Tips, Regulatory & Standards Compliance CE Mark, Classification, EU, Medical Device Directive, Quality Management System View
CE Mark Part 1, Selecting A Notified Body Posted by Bob Duffy on January 15, 2018 in Device Tips, Regulatory & Standards Compliance Canada, CE Mark, EU, Notified Body, Technical File View
