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?

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?

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?

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?

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?

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?

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?

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?

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?

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?

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?