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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.

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Regulatory, Digital Health, Quality Management Kunal K. Sengupta Regulatory, Digital Health, Quality Management Kunal K. Sengupta

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?

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