Drafter

Generate the cornerstone documents of your submission and QMS from the ground up.

✓ FDA

✓ MDR

✓ IVDR

✓ QMS

Drafter is a powerful agent that can create complex documents for your technical file and QMS certification starting with the Clinical/Performance Evaluation Plan, Risk Management Plan and Post-Market Surveillance Plan. It automates substantial preparatory work, for example to characterize the device, establish the state of the art, and identify foreseeable risks.

You select the Sherpa approval strategy assessment as starting point and the agent conducts an in-depth search of databases like PubMed, brings together a detailed overview of the medical condition, standard of care, and known risks to build-up a coherent and compliant clinical strategy.

Key Features

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Comprehensive Analysis

Maps claims to specific safety and performance requirements and identifies the exact evidence needed to establish safety and efficacy.

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Evidence-Based Traceability

Performs in-depth database searches (PubMed, Cochrane) with full traceability to underlying search queries and sources.

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Collaborative editing

You stay in control of each documentation artifact and can make changes easily by chatting with the agent.

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Manages dependencies

The agent tracks the impact of changes and highlights immediately flags all dependencies that need to be regenerated to make sure the deliverable is fully consistent.

Set your Clinical / Performance evaluation plan and draft other complex submission documents with confidence.

Drafter follows a structured process with expert-level analysis to create complex regulatory documents in minutes while keeping you in control.

Get a demo

Build cornerstone documents for your technical file in minutes

Clinical Evaluation Plan, Risk Managamanet Plan, Post-Market Surveillance Plan
Build step by step based on risk characterisation, state-of-the-art, risk identification, controls, etc
Compliant by design