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
Quality-by-Design for DCTs: Turning FDA’s DHT Framework Into an Inspection-Ready Reality
Could your digital endpoints survive if an FDA inspector asked you to “show how this was generated”?
Are your device, algorithm, and data teams aligned—or are they assuming someone else is handling the risk?
Do your SOPs actually support decentralized trials, or are they relics from the site-centric era?
Would your DHT data hold up across review divisions, or would firmware drift and missing lineage collapse your evidence?
Is your organization prepared for the roles it already holds—sponsor, architect, system producer, and regulated partner?
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?
The 2024 FDA DCT Guidance Decoded: 9 Operational Traps Sponsors Still Fall Into
What hidden operational traps are still tripping sponsors under the 2024 FDA DCT guidance?
How can sponsors maintain investigator oversight across decentralized models?
Why does device validation remain a recurring inspection finding?
What data integrity gaps most concern regulators in decentralized trials?
How can operational alignment with FDA guidance accelerate study approvals?
AI Software Assurance Framework for FDA-regulated applications
How does the AI Software Assurance Framework ensure compliance in FDA-regulated applications?
What are the key components of an effective AI Software Assurance Framework?
How can life sciences companies implement governance and accountability in AI development?
What role does risk management play in AI systems within regulated environments?
How does data management contribute to the integrity of AI-driven decisions in healthcare?
Ensuring Data Integrity in Medical Device and Pharma Companies: A Key to Compliance and Patient Safety
Are you confident your company’s data integrity can withstand an FDA audit?
Did you know over 75% of FDA audits uncover critical data integrity concerns?
Is your organization taking the right steps to safeguard patient safety through proper data validation?
Could lapses in data management be putting your company at risk of costly recalls and regulatory action?
How does data integrity impact the accuracy, reliability, and safety of your medical devices or pharmaceuticals?