CE certification 

Our team will be here to help you place your Medical Device on the EU market by being your guide on this journey.

As we are experts on Quality and Regulatory Affairs, we know that these areas cannot be separated. This is why we offer a full service to keep your business compliant.

CE Marking of your products

We offer you support to define your Regulatory Compliance strategy

Our experts will perform a full compliance check on your products and your Quality System

We will guide you on the building of your Technical Documentation and the Conformity Assessment Process

Our Medical Writers will help you create or update your Clinical Evaluation Reports (CER) or Post-marketing Clinical Follow-up (PMCF)

We can help you select the most appropriate Notified Body and organise a Technical Documentation Review with them prior to the final submission

Quality Management System

We can build your Quality Management System so it is compliant with ISO 13485

We can prepare your team and provide support during your third-party audits

In case of any vigilance reporting, we can help you evaluate the risks and define the actions required to remain compliant

During your Product Development phase, we can provide Quality and Regulatory Affairs support to help ensure that you are including the right data for your design file

Other Services

We can support your conversion to Digitalisation

If you need a Person Responsible for Regulatory Compliance, we can offer you our support

In Due Diligence, our experts can help you determine whether the Quality and Regulatory Affairs processes of the company are compliant or provide support in the acquisition of a new product

Training and Mentoring your team