Welcome to our blog, your go-to resource for the latest insights and trends in the life sciences industry.
Our blog is designed to provide expert guidance, practical tips, and thought leadership on key areas like medical device development, digital health, and clinical trial optimization. We cover a wide range of topics, including decentralized clinical trials (DCTs), the integration of digital health technologies (DHTs) in DCTs, and the use of Platform as a Service (PaaS) in medical device software development, to help you navigate the complex intersection of innovation and regulation. Our goal is to keep you informed and equipped with the knowledge needed to overcome industry challenges, drive innovation, and succeed in the rapidly advancing life sciences sector. Explore our blog for in-depth insights and the latest developments, and feel free to reach out if you need further assistance.
Categories:
- BYOD
- Clinical Research
- Cybersecurity & privacy
- Data Integrity
- Device Validation & Usability
- Digital Health
- Digital Health Technologies
- Digital health Technology
- Digital Transformation
- General
- Innovation
- Logistics
- MDR
- Medical Device Software Development
- Medical Devices
- Quality Management
- Regulatory
- Risk-Based Quality Management
- Usability
- Usability Testing
- Validation
- Wearables
Not in EUDAMED? If You Import the Device, the Obligations Are Already Yours
Who is the importer of record for the devices in your trial — and does that person know it?
If a device on your study isn’t in EUDAMED, can you still legally place it on the EU market? (Spoiler.)
Does “The manufacturer registered it” actually cover you — or just one of ten obligations?
What happens to your primary endpoint when a device gets held at customs for a missing registration?
When did your organisation last check whether it has an SRN — and who confirms it every two years?