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Qualio Blog: Quality & Compliance Hub
» Latest Articles
Categories
Medical Devices
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Compliance
Quality Systems
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483
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pma
premarket approval
premarket notification
Jan 19, 2021
•
4 min read
Medical Devices
3 Major Regulatory Requirements for SaMD Companies
By Ezra Kelderman
Jan 14, 2021
•
4 min read
Medical Devices
5 Major CAPA Medical Device Requirements
By Ezra Kelderman
Jan 13, 2021
•
17 min read
podcast
Unlocking funding with IP and the inspiring story behind HAI Solutions with Nick Perrenoud
By Robert Fenton
Jan 12, 2021
•
4 min read
Pharmaceutical
5 Amazing Life Sciences Companies to Watch in 2021
By Kelly Stanton
Jan 07, 2021
•
4 min read
Medical Devices
5 Fastest Growing Biotech Startups to Watch in 2021
By Kelly Stanton
Jan 06, 2021
•
20 min read
podcast
Spearheading the Life Science Industry with Claire Bonaci of Microsoft
By Robert Fenton
Jan 05, 2021
•
3 min read
iso
5 Key Elements of the ISO 13485 Standard
By Kelly Stanton
Dec 30, 2020
•
16 min read
podcast
Global Opportunities from Starting a Med Device Company in a Pandemic with Meow-Ludo
By Robert Fenton
Dec 22, 2020
•
4 min read
eQMS
5 Essential Elements of Quality Management Software
By Robert Fenton
Dec 22, 2020
•
2 min read
Updates
1% For All Life - Improving Healthcare Access for Vulnerable Populations
By Robert Fenton
Dec 18, 2020
•
1 min read
Case Studies
Linical Uses Qualio to Streamline CRO Efforts and Help Biotech and Pharma Companies Secure Regulatory Approval
By Robert Fenton
Dec 17, 2020
•
3 min read
iso9001
5 Key Elements of the ISO 9001 Standard
By Robert Fenton
Dec 16, 2020
•
14 min read
podcast
From Hippie to Med School to Entrepreneur with Dr. Hana, MD
By Robert Fenton
Dec 15, 2020
•
2 min read
eQMS
First Module of EUDAMED on Actor Registration Open
By Robert Fenton
Dec 15, 2020
•
5 min read
eQMS
5 Industry-Leading eQMS Vendors of 2021
By Robert Fenton
Dec 10, 2020
•
3 min read
FDA, Audit
5 FDA Audit Preparation Tips for Life Science Startups
By Robert Fenton
Dec 09, 2020
•
15 min read
podcast
4x Cancer Survivor to CEO/Founder. Patient-led Innovation with Cinde Dolphin.
By Robert Fenton
Dec 08, 2020
•
4 min read
Business
The 5 Best Medtech Startups to Watch in 2021
By Robert Fenton
Dec 03, 2020
•
17 min read
podcast
Insights from Biotech Investor and Pioneer Ron Shigeta
By Robert Fenton
Dec 02, 2020
•
3 min read
eQMS
5 Fundamentals of the CAPA Quality Process
By Robert Fenton
Nov 24, 2020
•
5 min read
Pharmaceutical
5 Amazing Startup Pharmaceutical Companies to Watch in 2021
By Robert Fenton
Nov 18, 2020
•
5 min read
Paper-Based
6 Things to Look for in Quality Management System Software for the Pharmaceutical Industry
By Ezra Kelderman
Nov 17, 2020
•
7 min read
Audit
The Best ISO 13485 Audit Checklists on the Web
By Robert Fenton
Nov 12, 2020
•
7 min read
Paper-Based
The Best QMS Software: The Pros and Cons of the 5 Top Options
By Robert Fenton
Nov 10, 2020
•
7 min read
eQMS, Quality-Driven
The 9 Core Elements of a Quality Management System
By Ezra Kelderman
Nov 10, 2020
•
4 min read
Compliance
Does an FDA Class 1 Medical Device List Exist?
By Robert Fenton
Nov 05, 2020
•
6 min read
eQMS, Quality-Driven
The 5 Noticeable Benefits of Implementing A Quality Management System in 2021
By Kelly Stanton
Nov 03, 2020
•
1 min read
Case Studies
IRISYS Uses Qualio to Help Biotech and Pharmaceutical Firms Secure FDA Approval
By Robert Fenton
Oct 29, 2020
•
1 min read
Case Studies
Alphazyme Uses Qualio to Produce Molecular Enzymes at Scale for Biotech Companies
By Robert Fenton
Oct 27, 2020
•
7 min read
Compliance
What Are the Differences in the FDA Medical Device Classes?
By Robert Fenton
Oct 22, 2020
•
6 min read
iso9001
The Difference Between ISO 13485 and ISO 9001 for Medical Devices
By Robert Fenton
Oct 20, 2020
•
6 min read
Quality Systems, Pharmaceutical
5 Objectives of Quality Assurance in the Pharmaceutical Industry
By Robert Fenton
Oct 15, 2020
•
3 min read
FDA, eQMS
FDA to Issue New Guidance on QMS Validation: 4 Major Changes
By Robert Fenton
Oct 13, 2020
•
3 min read
Compliance
5 Major IEC 62304 Compliance Mistakes Medical Software Manufacturers Make
By Robert Fenton
Oct 08, 2020
•
4 min read
Medical Devices
The ISO 13485 Checklist for Medical Device Manufacturers
By Robert Fenton
Oct 08, 2020
•
3 min read
Quality Systems
Quality Assurance vs. Quality Control: What's the Difference?
By Kelly Stanton
Oct 06, 2020
•
3 min read
Quality Systems, iso9001, eQMS
How Much Does an ISO 9001 Quality Management System Cost?
By Ezra Kelderman
Oct 01, 2020
•
3 min read
iso9001, eQMS
Top 10 ISO 9001 Quality Management System Requirements
By Robert Fenton
Sep 29, 2020
•
3 min read
Medical Devices, FDA, 510(k)
5 FDA Pre-Submission Tips for Medical Device Manufacturers
By Robert Fenton
Sep 29, 2020
•
1 min read
Case Studies
Proscia Uses Qualio to Bring High-Quality Medical Device Software to Pathologists around the World
By Robert Fenton
Sep 24, 2020
•
4 min read
Medical Devices
Understanding Risk Classification of Medical Devices: 3 Major Grades
By Robert Fenton
Sep 22, 2020
•
4 min read
Medical Devices
5 Medical Device Supplier Innovations in 2020
By Robert Fenton
Sep 17, 2020
•
4 min read
FDA, eQMS
A Complete Overview of the FDA 510(k) Process (And How to Shorten It)
By Robert Fenton
Sep 15, 2020
•
1 min read
Case Studies
CGX Uses Qualio to Deliver Innovative EEG Headsets to Medical Researchers
By Robert Fenton
Sep 10, 2020
•
10 min read
Pharmaceutical, Quality-Driven
The 8 Essential Elements of Quality Management For Pharmaceutical Companies
By Ezra Kelderman
Sep 10, 2020
•
7 min read
Quality-Driven
What to Look for in Quality Management Consulting Services (And When You Really Need Them)
By Kelly Stanton
Sep 08, 2020
•
3 min read
Medical Devices
4 Medical Device Manufacturers Revolutionizing Life Sciences in 2020
By Robert Fenton
Sep 03, 2020
•
5 min read
eQMS
What is eQMS Software Validation?
By Robert Fenton
Sep 01, 2020
•
5 min read
FDA
Review of the Top FDA Software Validation Requirements
By Robert Fenton
Aug 27, 2020
•
5 min read
Business
Top 7 Biotech Investors Changing the Life Science Industry
By Robert Fenton
Aug 25, 2020
•
6 min read
Medical Devices, eQMS
5 Essential Elements of a QMS for Medical Devices
By Robert Fenton
Aug 20, 2020
•
3 min read
Quality Systems
The 3 Top Quality Assurance Conferences of 2020
By Robert Fenton
Aug 18, 2020
•
2 min read
Business
Review of the 5 Best Life Science Venture Capital Firms
By Robert Fenton
Aug 13, 2020
•
3 min read
Business
5 Steps to Securing Life Science Venture Capital
By Robert Fenton
Aug 11, 2020
•
4 min read
Medical Devices
4 FDA Medical Device Reporting Procedures for Life Science Companies
By Robert Fenton
Aug 06, 2020
•
5 min read
Pharmaceutical
The Best Pharmaceutical Quality Assurance Courses Online
By Robert Fenton
Aug 04, 2020
•
5 min read
eQMS
5 Secrets to Securing Medical Device Venture Capital
By Robert Fenton
Jul 28, 2020
•
6 min read
Medical Devices
What's the Difference Between a Class I and Class II Medical Device?
By Robert Fenton
Jul 21, 2020
•
6 min read
Medical Devices
An ISO 13485 Risk Management Plan Example You Can Steal and Use
By Robert Fenton
Jul 16, 2020
•
3 min read
Quality-Driven
Qualio Secures Series A Funding
By Robert Fenton
Jul 14, 2020
•
6 min read
Compliance
A Printable 21 CFR Part 11 Compliance Checklist to Follow Step-by-Step
By Robert Fenton
Jul 09, 2020
•
10 min read
Medical Devices
What's the Best 21 CFR Part 11 Compliant Software in 2020?
By Robert Fenton
Jul 07, 2020
•
6 min read
iso9001
The Risks of ISO 9001 Nonconformance (And How It Impacts Your Organization)
By Robert Fenton
Jul 02, 2020
•
3 min read
Certification, eQMS
How to Get a Quality Management Certification in 5 Simple Steps
By Robert Fenton
Jun 30, 2020
•
4 min read
Medical Devices
5 Essential Tasks to Include in Your EU MDR Checklist
By Robert Fenton
Jun 25, 2020
•
3 min read
Medical Devices
The 5 Best ISO 14971 Training Programs
By Robert Fenton
Jun 23, 2020
•
4 min read
eQMS
5 Steps of a Quality Management Plan for Distributed Life Sciences Companies
By Robert Fenton
Jun 18, 2020
•
4 min read
Medical Devices
5 Online Medical Device Design Control Templates
By Robert Fenton
Jun 16, 2020
•
9 min read
Medical Devices
10 Impressive Medical Device Startups to Watch in 2021
By Robert Fenton
Jun 10, 2020
•
3 min read
Medical Devices
How to Build the Best Quality Assurance Plan for Distributed Medical Manufacturers
By Robert Fenton
May 28, 2020
•
5 min read
Quality Systems, eQMS
The 5 Best Pharmaceutical Quality Systems Changing Life Sciences in 2020
By Ezra Kelderman
May 21, 2020
•
4 min read
Medical Devices
The Top Medical Device Trends in 2020
By Robert Fenton
May 15, 2020
•
6 min read
Paper-Based
FDA Regulatory Compliance Software: Cloud vs. On-Premises
By Ezra Kelderman
May 14, 2020
•
3 min read
eQMS
5 Pharmaceutical Manufacturing and Quality Management Trends
By Robert Fenton
May 07, 2020
•
4 min read
Pharmaceutical
The 4 Phases of Clinical Trials (And How to Guarantee Quality Assurance During Every Step)
By Kelly Stanton
Apr 27, 2020
•
1 min read
Medical Devices
Qualio Named Top Performer in the Spring 2020 Quality Management Software Customer Success Report
By Robert Fenton
Apr 20, 2020
•
7 min read
Paper-Based
The 8 Essential Functions Of CAPA Management Software
By Ezra Kelderman
Apr 16, 2020
•
1 min read
eQMS, Product Updates
Single Sign-On With SAML2 Now Available for Qualio
By Joe O'Reilly
Apr 15, 2020
•
4 min read
eQMS
How to Set Up an ISO 14971 Risk Matrix in 5 Simple Steps
By Robert Fenton
Apr 08, 2020
•
3 min read
Medical Devices
How to Build an FDA Audit Strategy During the COVID-19 Pandemic
By Robert Fenton
Apr 01, 2020
•
4 min read
Medical Devices
The Medical Device Startup Process: Avoid These 7 Deadly Missteps
By Robert Fenton
Mar 26, 2020
•
4 min read
eQMS
EU Medical Device Regulation: Is Your eQMS Helping or Hurting?
By Robert Fenton
Mar 24, 2020
•
4 min read
eQMS
5 Tips to Get ISO 13485 / ISO 14971 Certification
By Robert Fenton
Mar 17, 2020
•
4 min read
Medical Devices
International Medical Device Regulations vs FDA 21 CFR: 4 Crucial Differences
By Robert Fenton
Mar 12, 2020
•
2 min read
Compliance
Quality Management Initiative for Coronavirus and COVID-19
By Robert Fenton
Mar 12, 2020
•
6 min read
Medical Devices
6 Best Practices from Six Sigma that Medical Device Companies Should Follow
By Robert Fenton
Mar 10, 2020
•
6 min read
Medical Devices
7 Medical Device Conferences to Get You Ready for EU MDR
By Robert Fenton
Mar 03, 2020
•
4 min read
Medical Devices
Design Controls for a Medical Device: 5 Secrets for Success
By Robert Fenton
Feb 27, 2020
•
7 min read
eQMS
7 ISO 13485:2016 Changes That Can Make Your Company Better
By Robert Fenton
Feb 25, 2020
•
7 min read
Medical Devices
The 5 Best Medical Device Product Lifecycle Management Tools
By Robert Fenton
Feb 20, 2020
•
5 min read
Pharmaceutical
The 6 Best US Pharmaceutical Conferences to Attend in 2020
By Robert Fenton
Feb 18, 2020
•
1 min read
Qualio Named Quality Management Leader in G2 Winter 2020 Momentum Report
By Robert Fenton
Feb 13, 2020
•
7 min read
Medical Devices, Quality Systems, eQMS, Compliance
14 Medical Device Quality Management System Requirements for Regulatory Compliance
By Ezra Kelderman
Feb 11, 2020
•
5 min read
Medical Devices
Medical Device Consultant Rates for 2020: What You Should Get for Your Investment
By Robert Fenton
Feb 06, 2020
•
5 min read
Medical Devices, Compliance
Medical Device Quality Assurance and Regulatory Compliance in 2020: What You Should Know
By Robert Fenton
Feb 04, 2020
•
4 min read
Medical Devices
The 6 Best Medical Device Consulting Services: What They Offer
By Robert Fenton
Jan 30, 2020
•
5 min read
Medical Devices
Reviewing the Best Medical Device Risk Management Consultant Options for 2020
By Robert Fenton
Jan 28, 2020
•
5 min read
Pharmaceutical
Finding the Best Pharmaceutical Regulatory Consulting Services for Your Organization
By Kelly Stanton
Jan 23, 2020
•
9 min read
Medical Devices, Quality Systems, eQMS
The 13 Essentials of a Quality Plan for Medical Device Companies
By Kelly Stanton
Jan 21, 2020
•
4 min read
Medical Devices, Quality Systems, eQMS
Medical Device Quality Management System Template: 5 Powerful Options
By Ezra Kelderman
Jan 16, 2020
•
6 min read
Medical Devices, Quality Systems, eQMS
Quality Management Software for Medical Devices: The 8 Essential Requirements
By Robert Fenton
Jan 14, 2020
•
7 min read
Medical Devices, Quality Systems, eQMS
Reviewing the Top Medical Device Quality Software Options for 2020
By Ezra Kelderman
Jan 09, 2020
•
6 min read
Quality Systems, Pharmaceutical
7 Signs You Need Pharmaceutical Quality Assurance Consulting
By Kelly Stanton
Jan 07, 2020
•
5 min read
Compliance
Medical Device Compliance Consulting: 11 Questions to Ask Before Hiring
By Robert Fenton
Jan 02, 2020
•
4 min read
Medical Devices
The 6 Top Medical Device Consulting Firms You Should Short List for 2020
By Robert Fenton
Dec 31, 2019
•
4 min read
Quality Systems, eQMS
Quality Management Services: The 4 Essential Qualifications to Look For
By Robert Fenton
Dec 26, 2019
•
4 min read
Quality Systems, eQMS
Life Sciences Quality Management System: 5 Must-Have Features & Functionality
By Robert Fenton
Dec 24, 2019
•
4 min read
Medical Devices
How Much Does Medical Device Regulatory Consulting Cost in 2020?
By Robert Fenton
Dec 19, 2019
•
4 min read
Quality Systems, Pharmaceutical
Understanding the Scope of Quality Assurance in the Pharmaceutical Industry
By Robert Fenton
Dec 17, 2019
•
4 min read
Quality Systems, eQMS
4 Examples of Continuous Improvement in Quality Management in Life Sciences Companies
By Robert Fenton
Dec 12, 2019
•
4 min read
Quality Systems
How to Create and Implement an Effective Quality System Plan
By Robert Fenton
Dec 10, 2019
•
7 min read
Medical Devices
5 Staggering Medical Device Recall Statistics That Should Concern Everyone
By Robert Fenton
Dec 05, 2019
•
8 min read
Document Control
Reviewing the Top 6 Document Version Control Software Options of 2020
By Robert Fenton
Dec 03, 2019
•
6 min read
Medical Devices, FDA
How Long Does the FDA Medical Device Approval Process Take?
By Robert Fenton
Nov 27, 2019
•
7 min read
Quality Systems, eQMS
6 Signs Your Quality Management Process Is Failing
By Robert Fenton
Nov 21, 2019
•
4 min read
Medical Devices
How Much Is the FDA Medical Device Registration Fee in 2020?
By Robert Fenton
Nov 19, 2019
•
6 min read
Medical Devices, Compliance
5 Common Medical Device Regulatory Compliance Problems Faced in 2020
By Robert Fenton
Nov 14, 2019
•
5 min read
Medical Devices
The Top 4 ISO 13485 Gap Analysis Templates: Pros and Cons
By Robert Fenton
Nov 12, 2019
•
5 min read
Quality Systems, Pharmaceutical
The Quality Policy of Pharmaceutical Industry Leaders Includes These 5 Things
By Robert Fenton
Nov 07, 2019
•
4 min read
Medical Devices
How to Shrink the FDA Medical Device Approval Timeline
By Robert Fenton
Nov 05, 2019
•
4 min read
Quality Systems
The 12 Essentials of Quality Management in Laboratory Environments
By Robert Fenton
Oct 31, 2019
•
5 min read
Quality Systems
How to Pass Every Quality Management Audit Without Breaking a Sweat
By Robert Fenton
Oct 29, 2019
•
6 min read
eQMS
7 ISO 9001 Quality Management System Requirements & Benefits
By Robert Fenton
Oct 24, 2019
•
5 min read
eQMS
How to Solve 5 Common Document Control Procedure Problems
By Robert Fenton
Oct 22, 2019
•
6 min read
eQMS
The 7 Best Online Quality Management Training Courses in 2020
By Robert Fenton
Oct 17, 2019
•
6 min read
Medical Devices
Preclinical Testing of Medical Devices: 7 Essential Steps to Prepare
By Robert Fenton
Oct 15, 2019
•
6 min read
Compliance
5 Medical Device Compliance Problems That Can Permanently Damage Life Sciences Companies
By Robert Fenton
Oct 10, 2019
•
6 min read
Audit
The 7 Fastest Ways to Fail an ISO Audit
By Robert Fenton
Oct 01, 2019
•
7 min read
Quality Systems
Solving the Four Most-Common Quality Management Issues
By Robert Fenton
Sep 26, 2019
•
6 min read
Quality Systems
The 4 Worst Supplier Quality Management Procedure Problems for Life Sciences Organizations
By Robert Fenton
Sep 24, 2019
•
8 min read
Compliance
5 Notorious Compliance Issues in the Pharmaceutical Industry (and How to Avoid Them)
By Robert Fenton
Sep 17, 2019
•
4 min read
Medical Devices, eQMS
Is Your eQMS Built for ISO 14971 Risk Management Compliance?
By Robert Fenton
Sep 12, 2019
•
5 min read
Medical Devices
The 6 Best Medical Device Regulatory Consulting Services in 2020
By Robert Fenton
Sep 10, 2019
•
5 min read
Paper-Based
Reviews of the Top Quality Document Control Software Options in 2020
By Robert Fenton
Sep 05, 2019
•
5 min read
eQMS, Document Control
9 Helpful Document Control Tips You Can Implement Right Now
By Robert Fenton
Sep 03, 2019
•
5 min read
Document Control
The 6 Common Document Control System Blunders That Hurt Life Sciences Companies the Most
By Robert Fenton
Aug 29, 2019
•
4 min read
eQMS
ICH Q10 Pharmaceutical Quality System: The Role of an eQMS
By Robert Fenton
Aug 27, 2019
•
5 min read
Compliance
ISO Compliance: The What, Why, and How for Life Sciences Companies
By Robert Fenton
Aug 20, 2019
•
5 min read
Compliance, 483
Why Did Medical Device FDA 483 Observations Drop 6.2% Last Year?
By Robert Fenton
Aug 15, 2019
•
8 min read
eQMS
How to Manage the Medical Device Software Development Process in Your eQMS
By Robert Fenton
Aug 13, 2019
•
8 min read
eQMS
What's the Best Quality Management System Software for the Pharmaceutical Industry?
By Robert Fenton
Aug 08, 2019
•
8 min read
eQMS
What's the Most Effective Pharmaceutical Quality Management System in 2019?
By Robert Fenton
Aug 01, 2019
•
6 min read
eQMS, Compliance
How to Enable Quality Controls in Life Sciences Marketing
By Robert Fenton
Jul 30, 2019
•
8 min read
Medical Devices
9 Ways Canadian Medical Device Regulations Differ From the US
By Robert Fenton
Jul 25, 2019
•
6 min read
Medical Devices
6 Essentials of a Clinical Evaluation Report (CER) for Medical Device Organizations
By Robert Fenton
Jul 23, 2019
•
4 min read
Paper-Based
What's the Best Corrective Action Database Software?
By Robert Fenton
Jul 18, 2019
•
6 min read
Medical Devices
Product Realization ISO 13485 In Layman's Terms
By Robert Fenton
Jul 16, 2019
•
5 min read
Medical Devices
4 Regulations That Apply to Medical Device CRO Selection
By Robert Fenton
Jul 11, 2019
•
4 min read
Medical Devices
The Pros and Cons of Medical Device Consulting
By Robert Fenton
Jul 09, 2019
•
6 min read
eQMS, Quality-Driven
The Anatomy of a Healthy QMS for Life Sciences Companies
By Ezra Kelderman
Jul 02, 2019
•
5 min read
Medical Devices
FDA Audit: Medical Device Companies Should Watch Out for These 7 Mistakes
By Robert Fenton
Jun 27, 2019
•
5 min read
Medical Devices
The EU Medical Device Regulation Timeline: What You Should Know in 2020
By Robert Fenton
Jun 25, 2019
•
4 min read
Medical Devices
6 Ways to Evaluate Contract Sales Organizations for Medical Device Companies
By Robert Fenton
Jun 20, 2019
•
5 min read
Medical Devices
How To Decide Which Conformity Assessment Medical Device Companies Should Choose
By Robert Fenton
Jun 04, 2019
•
5 min read
Medical Devices
Who’s the Best FDA Consultant for Medical Device Manufacturers? (Reviews)
By Robert Fenton
May 28, 2019
•
6 min read
Medical Devices
The Essential Parts of an ISO 13485 Medical Device Quality Management System
By Robert Fenton
May 23, 2019
•
6 min read
Compliance
How to Ensure Your Quality Management System Processes and Procedures are Compliant in 2020?
By Robert Fenton
May 02, 2019
•
8 min read
Pharmaceutical
What Is cGMP In The Pharmaceutical Industry? An Expert Roundup
By Robert Fenton
Apr 30, 2019
•
7 min read
Medical Devices
The 5 Best Medical Device Quality Assurance Training Options
By Robert Fenton
Apr 18, 2019
•
5 min read
Medical Devices, FDA, 510(k)
4 Reasons Overhauling FDA 510(k) is a Great Move
By Robert Fenton
Apr 09, 2019
•
4 min read
Compliance, Quality-Driven
Quality vs. Compliance: These 5 Questions Will Determine Your Focus
By Robert Fenton
Apr 04, 2019
•
5 min read
eQMS
How Much Does eQMS Software Cost?
By Robert Fenton
Apr 02, 2019
•
6 min read
Paper-Based
5 of the Best Options for Nonconformance Management Software
By Robert Fenton
Mar 28, 2019
•
7 min read
eQMS
4 Reasons You Need An Agile QMS (And The Easiest Way to Get One)
By Robert Fenton
Mar 26, 2019
•
5 min read
Medical Devices
What An ISO 13485 Quality Manual For Medical Devices Should Look Like
By Robert Fenton
Mar 21, 2019
•
6 min read
eQMS
5 Indispensable Features Of Enterprise Quality Management Software
By Robert Fenton
Mar 19, 2019
•
10 min read
Paper-Based
QMS Software: Open Source vs. Subscription? The Pros and Cons
By Robert Fenton
Mar 14, 2019
•
7 min read
eQMS, Document Control, Compliance
4 Part 11 Compliant Document Management Systems You Should Know About
By Robert Fenton
Mar 07, 2019
•
3 min read
eQMS
6 Essential Qualities of the Best eQMS Systems
By Robert Fenton
Mar 05, 2019
•
4 min read
Medical Devices
The 6 Most Common Warnings for FDA 21 CFR 820 Noncompliance
By Robert Fenton
Feb 27, 2019
•
4 min read
Medical Devices
How to Clear the 21 CFR 820.50 Hurdle in 7 Easy Steps
By Robert Fenton
Feb 14, 2019
•
5 min read
Paper-Based
The Top 5 Cloud-Based Quality Management System Options for 2020
By Robert Fenton
Jan 29, 2019
•
4 min read
Pharmaceutical, Quality-Driven
How to Achieve Effective Quality Assurance Even In the Most Complex Circumstances
By Robert Fenton
Jan 24, 2019
•
5 min read
eQMS, Pharmaceutical
QMS in Pharma: 3 Safeguards to Ensure You Meet Compliance Guidelines
By Robert Fenton
Jan 22, 2019
•
4 min read
Paper-Based
Why Your QMS System Software Isn't Really Guaranteeing Quality
By Robert Fenton
Jan 17, 2019
•
4 min read
iso9001
What is the Best ISO 13485 Quality Management System Software for 2020?
By Robert Fenton
Jan 15, 2019
•
9 min read
Document Control
What Is A Document Control System and Why Does it Matter?
By Robert Fenton
Jan 10, 2019
•
7 min read
eQMS, Document Control
How to Implement a Document Management Process in the Age of HIPAA
By Robert Fenton
Jan 08, 2019
•
7 min read
Paper-Based
What's the Best Quality Management Software? We Reviewed 6 Platforms
By Robert Fenton
Jan 03, 2019
•
5 min read
eQMS, Compliance
Understanding the Growing Need for Product Compliance Software in the Life Sciences Industry
By Robert Fenton
Dec 18, 2018
•
4 min read
Pharmaceutical, Compliance
The Essential Tools You Need to Achieve Total Compliance in the Pharmaceutical Industry
By Robert Fenton
Dec 12, 2018
•
4 min read
Pharmaceutical, Compliance
The Key to Future-Proofing Pharma Compliance
By Robert Fenton
Dec 05, 2018
•
5 min read
Quality-Driven
Quality Management In Healthcare: 5 Things to Expect in 2020
By Robert Fenton
Nov 29, 2018
•
5 min read
eQMS
13 Bottom Line-Boosting Benefits of a Quality Management System
By Robert Fenton
Nov 27, 2018
•
5 min read
Quality-Driven
Quality Management Consulting: How to Evaluate and Choose the Best Consultant
By Robert Fenton
Nov 15, 2018
•
5 min read
Paper-Based
QMS Software: 7 Features That Save You Time, Money, and Resources
By Robert Fenton
Mar 31, 2018
•
1 min read
Pharmacy, FDA
FDA Rolls Out New Drug Research and Development Pilot Program
By Leslie Standridge
Mar 28, 2018
•
2 min read
FDA, pma, 510(k), premarket approval, premarket notification
The Difference Between Premarket Notification 510(k) and Premarket Approval
By Leslie Standridge
Mar 13, 2018
•
3 min read
FDA
Qualio's Quick Guide to FDA Medical Device Classification
By Leslie Standridge
Nov 13, 2016
•
2 min read
Medical Devices, Compliance, Quality-Driven
9 Ways to Ensure Medical Product Compliance Through Quality
By Pat Flanders
Oct 11, 2016
•
1 min read
Medical Devices, FDA
FDA issues draft updated recommendations on submitting a new 510(k) for device modifications
By Pat Flanders
Oct 11, 2016
•
4 min read
483
What should I expect when the FDA comes knocking?
By Pat Flanders
Sep 28, 2016
•
1 min read
FDA
Pharmaceutical Testing, Training, Documentation Updates from the FDA
By Pat Flanders
Sep 28, 2016
•
3 min read
iso9001, eQMS, iso, Compliance
5 Ways that a QMS Improves ISO 9001 Management
By Pat Flanders
Sep 20, 2016
•
2 min read
Process, Quality-Driven
The Keys to Successful Life Sciences Product Development
By Pat Flanders
Sep 12, 2016
•
1 min read
Ireland, Quality-Driven
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Medical Devices, FDA
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Compliance
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Case Studies, Digital Health, Audit, SOC2 Type II
Case Study: eHealth Technologies SOC 2 Type II Certification
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