Clinical evaluation course: 09 October
This half day course will help you gain an understanding about the requirements on clinical data ...
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, ...
Training that builds confidence in compliance
Whether you're strengthening your internal capabilities, preparing for an audit, or launching a new ...
Access the UK market with confidence
Entering the UK market requires more than just registration—it requires the right regulatory ...
Recent clarification in Sweden’s clinical trial legislation
From 1 July 2026, a clarification in the Swedish Medicines Act has further defined the role of ...
Improved flexibility for CTIS submissions
A new “Article 11 workaround” is addressing a long-standing limitation in CTIS when working with ...
When your team needs reinforcement, not recruitment
Not every challenge calls for a permanent hire. Sometimes an experienced specialist is all it takes ...
Delivering outcomes that move projects forward
Our focus is on delivering the results you need—so your projects can keep moving forward. We've ...