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Latest release: March 2017New regulation update on audit and certification

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.





MDSAP Medical Device Single Audit Program



 CE marking for Medical Devices


> CE marking for IVD Devices


ISO Quality Management System (QMS)


Worldwide regulation

 Worldwide Regulations








combo ISO 13485 9001


We serve your passion for progress in the Medical Device (MD) and In Vitro Diagnostics (IVD) industry from the United States


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clientsWe're Hiring!

Due to rapid growth in North America, we're seeking Lead Auditors and Certification Project Managers responsible for medical device manufacturing clients.

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