Trusted Partner for navigating Notified Body reviews
100% success rate in NB reviews*
– whether from day one or as your rescue team
A Notified Body is an organisation designated by an EU country to assess the conformity of certain products before being placed on the market.
For most medium- and high-risk Medical Devices and IVD’s, a Notified Body must review your QMS and technical documentation.
If everything is in order, they issue a CE Certificate.
We help you through the process
From Start to Submission
We support companies throughout the full regulatory process – ensuring strategies and documentation meet NB expectations from the beginning.
- End-to-end support
- Proactive planning
- Regulatory and Clinical strategies built to pass
Rescue Missions That Deliver
Companies turn to us when their submission faces challenges – we help turn it around under tight deadlines.
- Gap analysis & corrective plans
- Fast, focused remediation
- Proven success in high-pressure cases
* Track record based on all NB-reviewed projects to date. Data on total case volume available upon request.