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
ALCOA++ in the Age of Digital Health Technologies (Part 5/8)
Can your audit trail reconstruct every DHT data transformation from source to submission?
Are firmware, algorithms, and databases synchronized under one ALCOA++ framework?
How do you manage data integrity across multiple vendors and jurisdictions?
Could your digital endpoints withstand an FDA or EMA data lineage audit?
Does your QMS explicitly integrate ALCOA++ and metadata provenance controls?
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?
Device Fit and Classification: When “Commercial” Becomes “Clinical” (Part 3/8)
Have you validated every DHT used in your trial for analytical, clinical, and usability accuracy?
Are you certain of each device’s risk class in all deployment countries?
How do you control firmware and algorithm updates during studies?
Who in your organization owns usability validation and change control?
Would your DHT-derived endpoints survive regulatory scrutiny tomorrow?
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?