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:
- Clinical Research
- Cybersecurity & privacy
- Data Integrity
- Device Validation & Usability
- Digital Health
- Digital Health Technologies
- Digital health Technology
- Digital Transformation
- General
- Innovation
- Medical Device Software Development
- Quality Management
- Regulatory
- Risk-Based Quality Management
- Usability Testing
Roles Redefined: Manufacturer, Importer, System Producer — Which Are You? (Part 6/8)
Are you certain your organization’s role under MDR or FDA law is correctly defined?
Have you appointed authorized importers or representatives for DHT deployments abroad?
Does your CRO or vendor contract include device vigilance responsibilities?
Are your system combinations documented under MDR Article 22 requirements?
If your DHT malfunctioned, could you prove who’s legally accountable?
Endpoints and Algorithms: How Firmware Can Break Your Study (Part 4/8)
Are your current DHTs validated for analytical, clinical, and usability accuracy?
Who in your organization owns responsibility for device version control?
Would your DHT endpoints withstand an ALCOA++ traceability audit?
Have you mapped classification and importer roles for every deployment country?
Does your QMS integrate ISO 13485 and 14971 for device-level oversight?
The DHT-Ready QMS: Integrating Device, Data, and Clinical Quality into One System (Part 2/8)
Does your QMS include design-history and validation records for every DHT you use?
Are firmware, algorithms, and human-factors results governed under change control?
Can your vendor audits prove ISO 13485 and IEC 62304 compliance?
How do you integrate ALCOA++ and device traceability into your audit system?
Would your QMS withstand an FDA or MDR inspection focused on digital endpoints?
The Shockwave: What the FDA’s DHT Framework Really Means (Part 1/8)
Are your current DHTs validated for analytical, clinical, and usability accuracy?
Who in your organization owns responsibility for device version control?
Would your DHT endpoints withstand an ALCOA++ traceability audit?
Have you mapped classification and importer roles for every deployment country?
Does your QMS integrate ISO 13485 and 14971 for device-level oversight?
ICH GCP E6 (R3): When Digital Health Became Everyone’s Responsibility
For years, Digital Health Technologies sat in an awkward middle ground in clinical trials.
Sponsors relied on them but didn’t always own them.
Vendors built them but weren’t always treated as GCP-relevant.
And regulators tolerated the ambiguity.
ICH GCP E6 (R3) quietly ends that arrangement.
Validation of Clinical Trial–Related Systems in Smaller Enterprises: Challenges and Practical Tips
How can small companies overcome the challenges of validating clinical trial systems on tight budgets?
What are the risks of not validating clinical trial systems in smaller enterprises?
Can lean validation strategies save time and money without sacrificing compliance?
Why is proper documentation crucial for clinical trial system validation?
How can startups ensure their systems are scalable and compliant as they grow?
ICH GCP E6 Is Changing — And Digital Health Technologies Are at the Center
For years, Digital Health Technologies lived slightly outside the GCP spotlight.
Useful? Yes.
Innovative? Absolutely.
GCP-critical? Not always.
ICH GCP E6 (R3) changes that.
The Perfect Clinical Trial of the Future: A Vision for Innovation, Efficiency, and Patient-Centricity
How will the “perfect clinical trial” of the future revolutionize patient engagement and efficiency?
What role do decentralized and virtual trials play in shaping the clinical trials of tomorrow?
Are you ready to embrace AI-driven innovations to improve the accuracy and speed of clinical trials?
How can patient-centric design make future clinical trials more inclusive and accessible?
What key features define the perfect clinical trial for improving outcomes and reducing costs?