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Latest release: March 2017
Notification of changes: How, what and when to communicate with your Notified Body
The Medical Device Industry has always been one of the most demanding when it comes to satisfying its stakeholders.
Satisfying and embracing the needs of multiple actors (market evolution, patient safety, investors, regulators and supply chains) has obligated Legal Manufacturers of medical devices to adapt to change in order to remain viable and in demand.
Medical Device Single Audit Program
CE marking for Medical Devices
CE marking for IVD Devices
Quality Management System (QMS)