Study the device in its real clinical workflow.

Start with intended use and study design

Identify the device, version, intended users, clinical setting and evidence objective. Distinguish clinical investigation, diagnostic-performance research and observational follow-up. Record whether procedures depart from routine care and whether results could influence patient management.

Assess product and ethics requirements together

NHRC's device-trial guidance addresses participant risk, consent and follow-up. DDA also publishes health-technology product requirements. Determine the applicable trial, import and product requirements with the authorities rather than assuming a foreign device classification or overseas approval establishes permission in Nepal.

Scope practical device support

Evaluate the required tasks and qualified delivery team before agreeing the scope.

• Site, user and procedure-workflow assessment
• Protocol and instructions-for-use training
• Device identification, accountability and maintenance arrangements
• Imaging and endpoint-documentation requirements
• Device-deficiency and safety-information escalation
• Follow-up, reconciliation and close-out

Plan consent and long-term follow-up

For implant studies, explain the implications of withdrawal and whether removal is clinically possible or appropriate. Specify late-event surveillance, clinical follow-up and accountability for ongoing care. For diagnostics, address specimen handling, result interpretation and how clinically significant findings will be managed.