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Rehabilitation with Robotic Exoskeleton
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The Easy Button for ISO 13485 Compliance.

  • Built for medical device innovators

  • Includes an AI-powered ISO 13485 eQMS

  • Streamlines the path to compliance and market readiness with tools and expert guidance.

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Everything you need to reach compliance quickly and at a low cost.

The

Tools

The

Guidance

What's Included?

The Tools

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eQMS software made for you 

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  • Controlled Document Management

  • Revision Tracking

  • Approval Workflows

  • Automated Quality Processes

  • Electronic Records

  • Workflow Management

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The Content

Don’t waste time recreating the wheel

Use our tested, tried, and true document and record templates

Document Templates

Pre-built Workflows

Document Control

Records Management

Management Review

Internal Audit Management

Feedback & Complaints

Corrective & Preventative Action (CAPA)

Nonconformance Reporting

Risk Management

Quality

Manual

Quality

Policy

Quality Objectives

Risk

Register

Procedural Documents

Training & Competency

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CORRECTIVE ACTION

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PREVENTATIVE ACTION

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FEEDBACK PROCESSING

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INTERNAL AUDIT

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SUPPLIER EVALUATION

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MANAGEMENT REVIEW

WEEK

1

Training & Implementation

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13485 Qlutch Overview

Document  Basics

WEEK

2

Documents Training

3

WEEK

Collaborative Work Session

4

WEEK

CAPA/ Workflow Training

5

WEEK

6

WEEK

Final Work Session

Includes 6 x 1 Hour Coaching Sessions

ISO Compliance Readiness

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Interested in hearing more?

Complete the Form Below

Company Status?
Pre-Legal Formation
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Your Status with Company
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Part-Time (10-30 hrs/wk)
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How did you hear about us?
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RBTC/RBIA
Carilion Clinic
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