Learn medical device

Quality management

We can help you build your complete Quality Management System for Medical Devices and even include our eQMS SmartEye

Regulatory affairs

We will help you register your products all over the world with the support of our team and network. We cover also MDSAP, EU MDR, IVDR, FDA, Middle East...

Compliance management

We can audit your company to comply with the internal audit requirement or audit your suppliers that you need to integrate on your Approved Supplier List. We can also execute Mock Inspection to test your company and be prepared for the real audit.

Innovation

You are in the process to design and develop a Medical Device? Then hire us to help you follow the requirements of the regulation from the beginning and not to have to redo that when the product will be already finished as this can cost you more money

Authorized Representatives

We have offices in EU, Switzerland and UK where we can become your Authorized Representatives. This is mandatory if your company is not located in these regions.

Importer

We are also offering the service of Importer for EU and Switzerland where we will execute all the inspections needed per the regulation and record all those elements on our files. An attestation of release will be provided to you as a proof that your product passed all the checks.