Stay up to date with our blog
Here you can find our latest blog entries.
Read our blog
Blog
Why EN ISO 13485 Matters for Medical Device Clinical Investigations
Clinical investigations begin long before the first patient A successful clinical investigation rarely begins when the first participant signs an informed consent form. In reality, ...
Read More
Blog
Clinical Study Myths: 5 Common Misconceptions Debunked
Clinical studies play a critical role in advancing healthcare. They help researchers evaluate new treatments, improve existing therapies, and generate evidence that ultimately benefits patients. ...
Read More
Blog
Digital Therapeutics in Vascular Diseases in the EU – with a Focus on Austria
Closing the Gap in Long-Term Care Cardiovascular diseases remain among the leading causes of mortality across Europe. While acute care is highly developed, a persistent ...
Read More
Blog
Recruitment Challenges in Cardiovascular Trials
Despite advances in trial design, digital health and patient engagement, recruitment remains one of the most critical bottlenecks in cardiovascular clinical trials, and many studies ...
Read More
Blog
EU MDR Compliance for Medical Devices: Market Entry Guide
Entering the European market has become significantly more complex under the Medical Device Regulation (EU) 2017/745 (MDR), making structured compliance a critical success factor for ...
Read More
Blog
AI Medical Software in the EU: Benefits, Risks and Regulation
Artificial-intelligence (AI)-driven medical software is increasingly being adopted in healthcare across Europe. Often referred to as AI-based software as a medical device (AI-SaMD) these systems ...
Read More






