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More than a Quality Management System: Tools for the entire MedTech Lifecycle.

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Featured Capabilities:

Document Management Product Development Design Control Risk Solutions Training Management CAPA Management

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Data collection and management designed for MedTech clinical trials.

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Featured Capabilities:

Electronic Data Capture (EDC) Electronic Case Report Forms (eCRF) Electronic Patient Reported Outcomes (ePRO) Ad-Hoc Data Collection (Cases) Post-Market Surveys

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Learn valuable, career-boosting skills for the Medical Device industry. Get access to hundreds of free resources as well as subscription-based courses and certifications.

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Checklists & Templates

Tips, checklists, and templates from seasoned medical device professionals available at your fingertips.

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Checklists and Templates

Validation Toolkit

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Checklists and Templates

Class 3 Medical Device Content Bundle

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Checklists and Templates

Class 2 Medical Device Content Bundle

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Checklists and Templates

Class 1 Medical Device Content Bundle

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Checklists and Templates

Clinical Evaluation Toolkit

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Checklists and Templates

Checklist for Protecting your IP throughout the MedTech Lifecycle

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Checklists and Templates

What to Include in Your Quality Assurance Agreement with a Distributor

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QMS Implementation Checklist Template

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Checklists and Templates

Quality Management System (QMS) Software Vendor Checklist

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Checklists and Templates

ISO 14971:2019 Gap Analysis Tool

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Checklists and Templates

15-in-1 MedTech Template Bundle

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Checklists and Templates

General Safety and Performance Requirements (GSPR) Gap Assessment

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5 Tips for IEC 60601 Submissions

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EU MDR Economic Operators Guidance Document

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Checklists and Templates

5 "Whys" for Root Cause Analysis Technique Cheat Sheet

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Checklists and Templates

CAPA Report Template

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Checklists and Templates

Quality Event Template Package for CAPAs, Complaints & Nonconformities

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Clinical Evaluation Procedure Template

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Checklist to Evaluate Your Quality Control Process

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Checklists and Templates

Design Transfer to Manufacturing

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Medical Device Reporting (MDR) Decision Tree

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How To Prepare An FDA Pre-Submission

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Periodic Safety Update Report Template

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Checklists and Templates

Abbreviated 510(k) Submission Checklist

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Checklists and Templates

Checklist For Selecting Suppliers + Contract Manufacturers

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Checklists and Templates

FDA Labeling Requirements Checklist

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Checklists and Templates

Checklist: Premarket Submission Documentation for Devices Containing Software

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Checklist for Structuring Your Technical Documentation

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Approved Supplier List Form Template

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Clinical Investigation Report Checklist

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Checklists and Templates

6 Tips for a Seamless Document Migration to Greenlight Guru

"Greenlight Guru provides an Electronic Quality Management System (eQMS) for medical device companies to ensure quality standards are met without requiring that the end ...

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Content Toolkit for Medical Device Startups

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MDR & IVDR Gap Analysis Toolkit

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5 Steps for Creating a Traceability Matrix

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Medical Device Project Plan

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510(k) Program Comparison Chart

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Total Quality Management 4-in-1 Tool

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Legacy vs Best-in-Class QMS Tools Comparison Chart

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Change Impact Analysis Template

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Change Order Template

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Nonconformance Report Template

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Checklists and Templates

Free Replay Package: 2021 Medical Device Virtual Summit

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Checklist: 7 Steps to Comply with FDA 21 CFR Part 11

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Checklists and Templates

Value of True Quality Infographic

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Training Matrix Template

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Top 100 Medical Device Startups with Most Money Raised in 2020 Chart

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Checklists and Templates

Biocompatibility Testing Selection Criteria

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Human Factors & Usability Engineering Report

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Complaint Template

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CAPA Template

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7 Steps for Writing a Nonconformance Report

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3 Tips for Receiving EUA from FDA

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Checklists and Templates

10 Ways A Modern, Cloud-Based MDQMS Helps Remote Teams Stay Ahead

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IVDR Gap Assessment Tool

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MDD vs. MDR Gap Assessment Tool

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5 Myths about PMA's (and what's actually true)

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Content Toolkit for Medical Device Executive Leaders

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Content Toolkit for Medical Device QA/RA Professionals

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Content Toolkit for Medical Device Product Developers

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Checklists and Templates

Quality Culture Flowchart

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EU MDR: SaMD Guidance Document + Audit Gap Assessment Tool

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21 CFR Part 820 Resource Pocket Guide for Avoiding Most Common Mistakes

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MDSAP vs. ISO 13485:2016 Gap Assessment Tool

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EU MDR Gap Analysis Tool

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Suggested Quality Domain Metrics

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Compliance or Quality Focused Comparison Chart

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What Influences SaMD Classification?

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Benefits of a Formal Document Management Solution

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5 FDA 510(k) Submission Mistakes to Avoid

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Checklists and Templates

What Medical Device Investors Want to See Checklist

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Checklists and Templates

FDA Program Comparison Table

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4 Cornerstones of an Effective eQMS

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6 Ways AI is Transforming Healthcare

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Top 100 Medical Device Companies in the World Chart

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Checklists and Templates

5 Practical R&D Tips for Medical Device Developers

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Checklists and Templates

10 Key Questions for Defining User Needs

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Checklists and Templates

7 Tips for Incorporating Human Factors into Device Design

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Checklists and Templates

Tips to Building Consistent QMS Procedures

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5 Tips for a Competitive Regulatory Strategy

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5 Tips for Better DHF Management Cheat Sheet

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Most Common Sources of Post-market Surveillance Data

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15 Steps to Create a Risk-based CAPA Process Infographic

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Checklists and Templates

Ultimate List of Medical Device Incubators & Accelerators

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4 Steps to Gathering Accurate Complaint Data

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Overview of a Customer Complaint-handling Procedure

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Checklists and Templates

Guide to When to Use Different Tools for CAPA Analysis

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Checklists and Templates

FDA 483 & Warning Letter Checklist

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Checklists and Templates

510(k) Submission Checklist

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Checklists and Templates

Cheat Sheet on Preparing Your Team for an FDA Inspection

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7 Signs You're Ready for an eQMS

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Checklists and Templates

5 Ways to Prepare Your Team for an FDA Inspection

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Checklists and Templates

Using Your 510(k) Submission for Design Controls and DHF Table

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5 Tips for Using a Predicate Device

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4 Signs You Need to Issue a CAPA

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Key Elements of Your Design History File Checklist

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Checklists and Templates

10 Resources to Get Medical Device Companies on Track

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Checklists and Templates

5 Key Steps for Getting Your Medical Device CE Mark

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Sample Management Review Template

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Checklists and Templates

Tips to Help Define User Needs

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Checklists and Templates

4 Helpful Tips for Better Management of Your Design History File

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Checklists and Templates

9 Tips for Password Compliance with 21 CFR Part 11

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4 Reasons the Root Cause Isn't "User Error" Cheatsheet

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What FDA Expects to See as Part of Your CAPA Process Cheatsheet

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5 Step Checklist to Determine If a CAPA Is Required

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Checklist for Selecting Suppliers to Your Medical Device Company

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4 Methods for Root Cause Analysis Cheat Sheet

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7 Rules for Effective Medical Device Design Controls Cheat Sheet

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Checklists and Templates

5 "Whys" for Root Cause Analysis Technique Cheat Sheet

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Checklists and Templates

5 Tips for a Successful 510(k) Submission

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8 Quick Facts about CAPA Cheat Sheet

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Checklists and Templates

ISO 13485:2016: Changes You Should Know About

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Checklists and Templates

ISO 13485:2016 vs FDA 21 CFR Part 820 Full Comparison Table

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Checklists and Templates

Failure Mode Effects Analysis (FMEA) Template

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Checklists and Templates

Medical Device Product Development Checklist

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Checklists and Templates

FDA QSR & ISO 13485: 2016 Internal QMS Audit Checklist

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Checklists and Templates

Budgeting for MedTech Clinical Activities Checklist

Securing the budget for clinical activities can be daunting, especially when you don't know where to start. Here's a checklist to break it down for you with key considerations on ...

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Checklists and Templates

21 CFR Part 11 compliance checklist for clinical records and e-signatures

Here are our pointers on what you should be aware of if you're looking to achieve compliance with FDA's 21 CFR Part 11, particularly when collecting or maintaining clinical data.

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Checklists and Templates

Checklist for Clinical Data Collection and Efficient Study Setup

Preparing for clinical data collection is a very important step. This checklist will help you consider some of the most important items before setting up your clinical study.

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Checklists and Templates

FDA 483/Warning Letter Response Template

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Checklists and Templates

Risk Management Plan Template

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