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,
Why EN ISO 13485 Matters for Medical Device Clinical Investigations Read More
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.
Clinical Study Myths: 5 Common Misconceptions Debunked Read More
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
Digital Therapeutics in Vascular Diseases in the EU – with a Focus on Austria Read More
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
EU MDR Compliance for Medical Devices: Market Entry Guide Read More
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
AI Medical Software in the EU: Benefits, Risks and Regulation Read More
