The IVDR transition is not over: key deadlines and common pitfalls
The core shift, as a reminder. IVDR (EU) 2017/746 replaced the former IVD Directive's largely ...
Category: Article
Need support with EUDAMED?
EUDAMED registration is now an important part of regulatory compliance for medical device and IVD ...
Change begins with the world's best question
Why do some changes become part of everyday practice while others remain little more than updated ...
Updated ISO 14155 standard for medical device studies
The updated ISO 14155:2026 standard for clinical investigations has now been published. While ...
Your partner for EU market access and compliance
For non-EU/EEA companies expanding into the EU market as a medical device or IVD manufacturer, ...
Access the UK market with confidence
Entering the UK market requires more than just registration—it requires the right regulatory ...
Expanding into the EU market as a medical device or IVD manufacturer?
Expanding into the EU market as a medical device or IVD manufacturer? For non-EU/EEA companies, ...
Imaging core lab and clinical adjudication
At Aurevia, we offer centralized adjudication and core lab services where experienced clinical ...
Navigating UK regulations doesn’t have to be complex
If you're a non-UK manufacturer, appointing a UK Responsible Person (UKRP) is mandatory for placing ...