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?

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?

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?

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?

If your digital health tool is already collecting endpoint data, are you absolutely sure regulators don’t see it as a medical device?

Who’s carrying the legal liability for your connected device right now—the manufacturer, the sponsor, or… you?

When your next trial audit lands, will your documentation prove compliance—or just prove confusion?

How confident are you that your “wellness app” wouldn’t trigger MDR or FDA oversight if used tomorrow in a global study?

While others are quietly securing their regulatory status, are you still assuming “we’re not a medical device company”?

For years, Digital Health Technologies sat in an awkward middle ground in clinical trials.

Sponsors relied on them but didn’t always own them.
Vendors built them but weren’t always treated as GCP-relevant.
And regulators tolerated the ambiguity.

ICH GCP E6 (R3) quietly ends that arrangement.

For years, Digital Health Technologies lived slightly outside the GCP spotlight.
Useful? Yes.
Innovative? Absolutely.
GCP-critical? Not always.

ICH GCP E6 (R3) changes that.

How is the rise of telemedicine reshaping the landscape of medical device innovation?

What new opportunities does telemedicine present for developing cutting-edge medical devices?

Are your medical devices ready to meet the growing demand for remote monitoring and treatment?

How can embracing telemedicine help your company expand into new markets and revenue streams?