Contact person: Business Client

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Location: Tangerang, Indonesia

Budget: Recommended by industry experts

Time to start: As soon as possible

Project description:
"The task is to take our current regulatory package for an AI-based wellness software device and make it trial-ready under Indian rules.
Specifically, I need a seasoned eye on the informed consent forms. Beyond confirming that they echo the ICMR Ethical Guidelines (2017), every line must feel clear and complete to a lay participant. At the same time, the updated text and any supporting notes must dovetail with the risk-management requirements laid out in MDR 2017.

The work is remote, light in volume but detail-heavy, and should wrap up within a few weeks. A background in Indian device submissions, software as a medical device, or similar clinical dossiers will let you move quickly.

Deliverables (all electronic, English):
• Tracked-change version of the consent form with recommended edits
• Clean “ready-to-file” version
• Brief gap-analysis memo mapping the form to both ICMR and MDR risk-management clauses
• One follow-up call to walk through any regulator-facing questions

Acceptance is contingent on the memo showing direct clause-by-clause linkage and the consent form passing an internal readability test (Flesch-Kincaid Grade ≤ 8)." (client-provided description)