Quality Management System
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
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
Importing Medical Devices?
Our partner provides post-production support services primarily to Medical Devices companies wanting to outsource Call-handling and portions of Complaint Handling, Medical Device Reporting, U.S. Agent and FDA Initial Importer services.
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