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

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Featured Capabilities:

Document Management Training Management Product Development Design Control Risk Management CAPA Management Audit 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 Product Add-Ons

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Ultimate Guide to Comparing Quality Management System Solutions

This eBook compares the best QMS software solutions to help medical device companies make an informed decision when investing in a quality management system.

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Checklists & Templates

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

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Verification Protocol Template
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Content Toolkit for Medical Device Product Developers
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FDA Pre-Submission Meeting Checklist for Medical Device Companies
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GSPR Template
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Medical Devices Essential Principles Checklist
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MDSAP QMS Audit Checklist
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Clinical Investigation Plan (CIP) Synopsis Template
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Resource Bundle for Risk Managers
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FDA QSR, QMSR & ISO 13485:2016 Internal Audit Checklist
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Premarket Approval Inspection Checklist
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MDSAP vs. ISO 13485:2016 Gap Assessment Tool
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FDA QMSR & ISO 13485:2016 QMS Internal Audit Checklist
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Cybersecurity Gap Assessment Checklist
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Align Your Clinical Claims Webinar Q&A
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ChatGPT Sample Prompts for Risk Evaluation of a Medical Device
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Training Matrix Template
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How to Clear a Software Medical Device
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Validation Toolkit
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Class 1 Medical Device Content Bundle
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Class 2 Medical Device Content Bundle
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Class 3 Medical Device Content Bundle
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Clinical Evaluation Toolkit
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MDR & IVDR Gap Analysis Toolkit
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Budgeting for MedTech Clinical Activities Checklist
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Checklist for Protecting your IP throughout the MedTech Lifecycle
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What to Include in Your Quality Assurance Agreement with a Distributor
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QMS Implementation Checklist Template
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Quality Management System (QMS) Software Vendor Checklist
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ISO 14971:2019 Gap Analysis Tool
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15-in-1 MedTech Template Bundle
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General Safety and Performance Requirements (GSPR) Gap Assessment
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Top 30 MDCG Guidance Documents for Medical Device Companies
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Top 40 IMDRF Technical Documents for Medical Devices
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MDD vs. MDR Gap Assessment Tool
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Checklist for Clinical Data Collection and Efficient Study Setup
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Checklist to Evaluate Your Quality Control Process
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5 Tips for IEC 60601 Submissions
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21 CFR Part 11 compliance checklist for clinical records and e-signatures
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How to Plan a Clinical Data Management Setup for EDC Systems
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EU MDR Gap Analysis Tool
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CAPA Report Template
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5 Tips for a Successful 510(k) Submission
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10 Resources to Get Medical Device Companies on Track
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6 Tips for a Seamless Document Migration to Greenlight Guru
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Design Transfer to Manufacturing
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Clinical Evaluation Procedure Template
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Checklist for Structuring Your Technical Documentation
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Checklist: Premarket Submission Documentation for Devices Containing Software
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FDA Labeling Requirements Checklist
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Abbreviated 510(k) Submission Checklist
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Periodic Safety Update Report Template
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How To Prepare An FDA Pre-Submission
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10 Ways A Modern, Cloud-Based Medical Device QMS Helps Remote Teams Stay Ahead
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3 Tips for Receiving EUA from FDA
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7 Steps for Writing a Nonconformance Report
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Human Factors & Usability Engineering Report
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Biocompatibility Testing Selection Criteria
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Top 100 Medical Device Startups with Most Money Raised in 2020 Chart
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Value of True Quality Infographic
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Checklist: 7 Steps to Comply with FDA 21 CFR Part 11
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Free Replay Package: 2021 Medical Device Virtual Summit
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Nonconformance Report Template
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Change Order Template
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Change Impact Analysis Template
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Legacy vs Best-in-Class QMS Tools Comparison Chart
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Total Quality Management 4-in-1 Tool
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510(k) Program Comparison Chart
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Medical Device Project Plan
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5 Steps for Creating a Traceability Matrix
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Clinical Investigation Report Checklist
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Approved Supplier List Form Template
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21 CFR Part 820 Resource Pocket Guide for Avoiding Most Common Mistakes
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Quality Culture Flowchart
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5 Myths about PMA's (and what's actually true)
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4 Signs You Need to Issue a CAPA
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5 Tips for Using a Predicate Device
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Using Your 510(k) Submission for Design Controls and DHF Table
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5 Ways to Prepare Your Team for an FDA Inspection
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7 Signs You're Ready for an eQMS
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Cheat Sheet on Preparing Your Team for an FDA Inspection
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510(k) Submission Checklist
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FDA 483 & Warning Letter Checklist
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Guide to When to Use Different Tools for CAPA Analysis
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Ultimate List of Medical Device Incubators & Accelerators
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15 Steps to Create a Risk-based CAPA Process Infographic
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Most Common Sources of Post-market Surveillance Data
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5 Tips for Better DHF Management Cheat Sheet
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5 Tips for a Competitive Regulatory Strategy
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Tips to Building Consistent QMS Procedures
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7 Tips for Incorporating Human Factors into Device Design
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10 Key Questions for Defining User Needs
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5 Practical R&D Tips for Medical Device Developers
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Top 100 Medical Device Companies in the World Chart
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6 Ways AI is Transforming Healthcare
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4 Cornerstones of an Effective eQMS
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FDA Program Comparison Table
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What Medical Device Investors Want to See Checklist
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5 FDA 510(k) Submission Mistakes to Avoid
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Benefits of a Formal Document Management Solution
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What Influences SaMD Classification?
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Compliance or Quality Focused Comparison Chart
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Suggested Quality Domain Metrics
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FDA QSR & ISO 13485: 2016 Internal QMS Audit Checklist
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Medical Device Product Development Checklist
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Failure Mode Effects Analysis (FMEA) Template
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ISO 13485:2016 vs FDA 21 CFR Part 820 Full Comparison Table
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ISO 13485:2016: Changes You Should Know About
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8 Quick Facts about CAPA Cheat Sheet
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7 Rules for Effective Medical Device Design Controls Cheat Sheet
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5 Step Checklist to Determine If a CAPA Is Required
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What FDA Expects to See as Part of Your CAPA Process Cheatsheet
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9 Tips for Password Compliance with 21 CFR Part 11
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4 Helpful Tips for Better Management of Your Design History File
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Tips to Help Define User Needs
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Sample Management Review Template
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5 Key Steps for Getting Your Medical Device CE Mark
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Key Elements of Your Design History File Checklist
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Checklist For Selecting Suppliers + Contract Manufacturers
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FDA 483/Warning Letter Response Template
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Risk Management Plan Template
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Content Toolkit for Medical Device Startups
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IVDR Gap Assessment Tool
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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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EU MDR Economic Operators Guidance Document
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EU MDR: SaMD Guidance Document + Audit Gap Assessment Tool

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