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
- Logistics
- Medical Device Software Development
- Quality Management
- Regulatory
- Risk-Based Quality Management
- Usability
- Usability Testing
- Validation
How to Survive – and Win – in the New Digital Health Economy (Part 8/8)
Is your organization’s QMS built to manage devices, data, and endpoints together?
Would your DHT-derived evidence survive a multi-country audit?
Who in your team owns algorithm validation and version control?
How prepared are your vendors to meet ISO 13485 and MDR Article 22 obligations?
Can you trace every data point from patient to protocol—and back again?
The Global Compliance Map: Deploying DHTs Across Borders (Part 7/8)
Are your DHTs classified and registered in every country where they’re used?
Have you appointed local importers and authorized representatives?
Do your vendor contracts cover data residency and cross-border transfers?
Can you demonstrate ALCOA++ traceability across countries and cloud regions?
Would your trial survive a multi-authority inspection tomorrow?
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?
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?
From Concept to Market: Best Practices for Developing Compliant Safety-Critical Medical Software
What are the essential regulatory requirements for developing safety-critical medical software?
How can a robust quality management system enhance compliance in medical software development?
What role does thorough documentation play in the approval process of medical software?
How can developers effectively assess and mitigate risks in safety-critical medical software?
Why is post-market surveillance crucial for the success of medical software products?