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Latest release: May 2017
Control of Critical Suppliers for Medical Devices: ISO 13485:2016 perspectives
The ISO 13485 standard represents a Quality Management System base for many regulatory schemes.
With the recent publication of the new Medical Device and In Vitro Diagnostic Regulations, the regulatory framework surrounding Medical Devices evolves and re-enforces the control of external parties (Suppliers, Subcontractors).
The newest revision of the ISO 13485 standard published in March 2016 aims in the very same direction.
Medical Device Single Audit Program
CE marking for Medical Devices
CE marking for IVD Devices
Quality Management System (QMS)