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eQMS
March 26, 2020
by Robert Fenton
EU Medical Device Regulation: Is Your eQMS Helping or Hurting?
eQMS
March 24, 2020
by Robert Fenton
5 Tips to Get ISO 13485 / ISO 14971 Certification
Medical Devices
March 19, 2020
by Robert Fenton
5 Online Medical Device Design Control Templates
Medical Devices
March 17, 2020
by Robert Fenton
International Medical Device Regulations vs FDA 21 CFR: 4 Crucial Differences
Compliance
March 12, 2020
by Robert Fenton
Quality Management Initiative for Coronavirus and COVID-19
Medical Devices
March 12, 2020
by Robert Fenton
6 Best Practices from Six Sigma that Medical Device Companies Should Follow
Medical Devices
March 10, 2020
by Robert Fenton
7 Medical Device Conferences to Get You Ready for EU MDR
eQMS
March 5, 2020
by Robert Fenton
5 Secrets to Securing Medical Device Venture Capital
Medical Devices
March 3, 2020
by Robert Fenton
Design Controls for a Medical Device: 5 Secrets for Success
eQMS
February 27, 2020
by Robert Fenton
7 ISO 13485:2016 Changes That Can Make Your Company Better
Medical Devices
February 25, 2020
by Robert Fenton
The 5 Best Medical Device Product Lifecycle Management Tools
Pharmaceutical
February 20, 2020
by Robert Fenton
The 6 Best US Pharmaceutical Conferences to Attend in 2020
February 18, 2020
by Robert Fenton
Qualio Named Quality Management Leader in G2 Winter 2020 Momentum Report
Medical Devices
February 18, 2020
by Robert Fenton
10 Impressive Medical Device Startups to Watch in 2020
Medical Devices
February 13, 2020
by Robert Fenton
14 Medical Device Quality Management System Requirements for Regulatory Compliance
Medical Devices
February 11, 2020
by Robert Fenton
Medical Device Consultant Rates for 2020: What You Should Get for Your Investment
Medical Devices
February 6, 2020
by Robert Fenton
Medical Device Quality Assurance and Regulatory Compliance in 2020: What You Should Know
Medical Devices
February 4, 2020
by Robert Fenton
The 6 Best Medical Device Consulting Services: What They Offer
Medical Devices
January 30, 2020
by Robert Fenton
Reviewing the Best Medical Device Risk Management Consultant Options for 2020
Pharmaceutical
January 28, 2020
by Robert Fenton
Finding the Best Pharmaceutical Regulatory Consulting Services for Your Organization
Medical Devices
January 23, 2020
by Robert Fenton
The 13 Essentials of a Quality Plan for Medical Device Companies
Medical Devices
January 21, 2020
by Robert Fenton
Medical Device Quality Management System Template: 5 Powerful Options
Medical Devices
January 16, 2020
by Robert Fenton
Quality Management Software for Medical Devices: The 8 Essential Requirements
Medical Devices
January 14, 2020
by Robert Fenton
Reviewing the Top Medical Device Quality Software Options for 2020
Quality Systems
January 9, 2020
by Robert Fenton
7 Signs You Need Pharmaceutical Quality Assurance Consulting
Compliance
January 7, 2020
by Robert Fenton
Medical Device Compliance Consulting: 11 Questions to Ask Before Hiring
Medical Devices
January 2, 2020
by Robert Fenton
The 6 Top Medical Device Consulting Firms You Should Short List for 2020
Quality Systems
December 31, 2019
by Robert Fenton
Quality Management Services: The 4 Essential Qualifications to Look For
Quality Systems
December 26, 2019
by Robert Fenton
Life Sciences Quality Management System: 5 Must-Have Features & Functionality
Medical Devices
December 24, 2019
by Robert Fenton
How Much Does Medical Device Regulatory Consulting Cost in 2020?
Quality Systems
December 19, 2019
by Robert Fenton
Understanding the Scope of Quality Assurance in the Pharmaceutical Industry
Quality Systems
December 17, 2019
by Robert Fenton
4 Examples of Continuous Improvement in Quality Management in Life Sciences Companies
Quality Systems
December 12, 2019
by Robert Fenton
How to Create and Implement an Effective Quality System Plan
Medical Devices
December 10, 2019
by Robert Fenton
5 Staggering Medical Device Recall Statistics That Should Concern Everyone
Document Control
December 5, 2019
by Robert Fenton
Reviewing the Top 6 Document Version Control Software Options of 2020
Medical Devices
December 3, 2019
by Robert Fenton
How Long Does the FDA Medical Device Approval Process Take?
Quality Systems
November 27, 2019
by Robert Fenton
6 Signs Your Quality Management Process Is Failing
Quality Systems
November 26, 2019
by Robert Fenton
5 Objectives of Quality Assurance in the Pharmaceutical Industry
Medical Devices
November 21, 2019
by Robert Fenton
How Much Is the FDA Medical Device Registration Fee in 2020?
Medical Devices
November 19, 2019
by Robert Fenton
5 Common Medical Device Regulatory Compliance Problems Faced in 2019
Medical Devices
November 14, 2019
by Robert Fenton
The Top 4 ISO 13485 Gap Analysis Templates: Pros and Cons
Quality Systems
November 12, 2019
by Robert Fenton
The Quality Policy of Pharmaceutical Industry Leaders Includes These 5 Things
Medical Devices
November 7, 2019
by Robert Fenton
How to Shrink the FDA Medical Device Approval Timeline
Quality Systems
November 5, 2019
by Robert Fenton
The 12 Essentials of Quality Management in Laboratory Environments
Quality Systems
October 31, 2019
by Robert Fenton
How to Pass Every Quality Management Audit Without Breaking a Sweat
eQMS
October 29, 2019
by Robert Fenton
7 ISO 9001 Quality Management System Requirements & Benefits
eQMS
October 24, 2019
by Robert Fenton
How to Solve 5 Common Document Control Procedure Problems
eQMS
October 22, 2019
by Robert Fenton
The 7 Best Online Quality Management Training Courses in 2020
Medical Devices
October 17, 2019
by Robert Fenton
Preclinical Testing of Medical Devices: 7 Essential Steps to Prepare
Compliance
October 15, 2019
by Robert Fenton
5 Medical Device Compliance Problems That Can Permanently Damage Life Sciences Companies
Audit
October 10, 2019
by Robert Fenton
The 7 Fastest Ways to Fail an ISO Audit
Audit
October 8, 2019
by Robert Fenton
The Best ISO 13485 Audit Checklists on the Web
Quality Systems
October 3, 2019
by Robert Fenton
Quality Assurance vs. Quality Control: What's the Difference?
Quality Systems
October 1, 2019
by Robert Fenton
Solving the Four Most-Common Quality Management Issues
Quality Systems
September 26, 2019
by Robert Fenton
The 4 Worst Supplier Quality Management Procedure Problems for Life Sciences Organizations
Compliance
September 24, 2019
by Robert Fenton
5 Notorious Compliance Issues in the Pharmaceutical Industry (and How to Avoid Them)
Pharmaceutical
September 19, 2019
by Robert Fenton
The Best Pharmaceutical Quality Assurance Courses Online
Medical Devices
September 17, 2019
by Robert Fenton
Is Your eQMS Built for ISO 14971 Risk Management Compliance?
Medical Devices
September 12, 2019
by Robert Fenton
The 6 Best Medical Device Regulatory Consulting Services in 2020
Paper-Based
September 10, 2019
by Robert Fenton
Reviews of the Top Quality Document Control Software Options in 2020
eQMS
September 5, 2019
by Robert Fenton
9 Helpful Document Control Tips You Can Implement Right Now
Document Control
September 3, 2019
by Robert Fenton
The 6 Common Document Control System Blunders That Hurt Life Sciences Companies the Most
eQMS
August 29, 2019
by Robert Fenton
ICH Q10 Pharmaceutical Quality System: The Role of an eQMS
Compliance
August 27, 2019
by Robert Fenton
ISO Compliance: The What, Why, and How for Life Sciences Companies
Compliance
August 22, 2019
by Robert Fenton
Does an FDA Class 1 Medical Device List Exist?
Compliance
August 20, 2019
by Robert Fenton
Why Did Medical Device FDA 483 Observations Drop 6.2% Last Year?
eQMS
August 15, 2019
by Robert Fenton
How to Manage the Medical Device Software Development Process in Your eQMS
eQMS
August 13, 2019
by Robert Fenton
What's the Best Quality Management System Software for the Pharmaceutical Industry?
eQMS
August 8, 2019
by Robert Fenton
What's the Most Effective Pharmaceutical Quality Management System in 2019?
Compliance
August 6, 2019
by Robert Fenton
What Are the Differences in the FDA Medical Device Classes?
eQMS
August 1, 2019
by Robert Fenton
How to Enable Quality Controls in Life Sciences Marketing
Medical Devices
July 30, 2019
by Robert Fenton
9 Ways Canadian Medical Device Regulations Differ From the US
Medical Devices
July 25, 2019
by Robert Fenton
6 Essentials of a Clinical Evaluation Report (CER) for Medical Device Organizations
Paper-Based
July 23, 2019
by Robert Fenton
What's the Best Corrective Action Database Software?
Medical Devices
July 18, 2019
by Robert Fenton
Product Realization ISO 13485 In Layman's Terms
Medical Devices
July 16, 2019
by Robert Fenton
4 Regulations That Apply to Medical Device CRO Selection
Medical Devices
July 11, 2019
by Robert Fenton
The Pros and Cons of Medical Device Consulting
eQMS
July 9, 2019
by Robert Fenton
The Anatomy of a Healthy QMS for Life Sciences Companies
Medical Devices
July 2, 2019
by Robert Fenton
FDA Audit: Medical Device Companies Should Watch Out for These 7 Mistakes
Medical Devices
June 27, 2019
by Robert Fenton
The EU Medical Device Regulation Timeline: What You Should Know (in 2019)
Medical Devices
June 25, 2019
by Robert Fenton
6 Ways to Evaluate Contract Sales Organizations for Medical Device Companies
Medical Devices
June 20, 2019
by Robert Fenton
How To Decide Which Conformity Assessment Medical Device Companies Should Choose
Medical Devices
June 4, 2019
by Robert Fenton
Who’s the Best FDA Consultant for Medical Device Manufacturers? (Reviews)
Medical Devices
May 30, 2019
by Robert Fenton
What's the Best 21 CFR Part 11 Compliant Software in 2019?
Medical Devices
May 28, 2019
by Robert Fenton
The Essential Parts of an ISO 13485 Medical Device Quality Management System
Compliance
May 23, 2019
by Robert Fenton
How to Ensure Your Quality Management System Processes and Procedures are Compliant in 2019
Paper-Based
May 21, 2019
by Robert Fenton
FDA Regulatory Compliance Software: Cloud vs. On-Premises
Medical Devices
May 16, 2019
by Robert Fenton
An ISO 13485 Risk Management Plan Example You Can Steal and Use
iso9001
May 14, 2019
by Robert Fenton
The Difference Between ISO 13485 and ISO 9001 for Medical Devices
Paper-Based
May 9, 2019
by Robert Fenton
The Best QMS Software: The Pros and Cons of the 5 Top Options
Pharmaceutical
May 2, 2019
by Robert Fenton
What Is cGMP In The Pharmaceutical Industry? An Expert Roundup
Medical Devices
April 30, 2019
by Robert Fenton
The 5 Best Medical Device Quality Assurance Training Options
Paper-Based
April 23, 2019
by Robert Fenton
The 8 Essential Functions Of CAPA Management Software
Medical Devices
April 18, 2019
by Robert Fenton
4 Reasons Overhauling FDA 510(k) is a Great Move
Compliance
April 16, 2019
by Robert Fenton
A Printable 21 CFR Part 11 Compliance Checklist to Follow Step-by-Step
Compliance
April 9, 2019
by Robert Fenton
Quality vs. Compliance: These 5 Questions Will Determine Your Focus
eQMS
April 4, 2019
by Robert Fenton
How Much Does eQMS Software Cost?
Paper-Based
April 2, 2019
by Robert Fenton
5 of the Best Options for Nonconformance Management Software
eQMS
March 28, 2019
by Robert Fenton
4 Reasons You Need An Agile QMS (And The Easiest Way to Get One)
Medical Devices
March 26, 2019
by Robert Fenton
What An ISO 13485 Quality Manual For Medical Devices Should Look Like
eQMS
March 21, 2019
by Robert Fenton
5 Indispensable Features Of Enterprise Quality Management Software
Paper-Based
March 19, 2019
by Robert Fenton
QMS Software: Open Source vs. Subscription? The Pros and Cons
eQMS
March 14, 2019
by Robert Fenton
4 Part 11 Compliant Document Management Systems You Should Know About
eQMS
March 7, 2019
by Robert Fenton
6 Essential Qualities of the Best eQMS Systems
Medical Devices
March 5, 2019
by Robert Fenton
The 6 Most Common Warnings for FDA 21 CFR 820 Noncompliance
Medical Devices
February 27, 2019
by Robert Fenton
How to Clear the 21 CFR 820.50 Hurdle in 7 Easy Steps
Paper-Based
February 14, 2019
by Robert Fenton
The Top 5 Cloud-Based Quality Management System Options for 2019
eQMS
February 12, 2019
by Robert Fenton
The 9 Core Elements of a Quality Management System
Pharmaceutical
February 7, 2019
by Robert Fenton
The 8 Essential Elements of Quality Management For Pharmaceutical Companies
eQMS
February 5, 2019
by Robert Fenton
The 5 Noticeable Benefits of Implementing A Quality Management System
Quality-Driven
January 31, 2019
by Robert Fenton
What to Look for in Quality Management Consulting Services (And When You Really Need Them)
Pharmaceutical
January 29, 2019
by Robert Fenton
How to Achieve Effective Quality Assurance Even In the Most Complex Circumstances
eQMS
January 24, 2019
by Robert Fenton
QMS in Pharma: 3 Safeguards to Ensure You Meet Compliance Guidelines
Paper-Based
January 22, 2019
by Robert Fenton
Why Your QMS System Software Isn't Really Guaranteeing Quality
iso9001
January 17, 2019
by Robert Fenton
What is the Best ISO 13485 Quality Management System Software for 2019?
Document Control
January 15, 2019
by Robert Fenton
What Is A Document Control System and Why Does it Matter?
eQMS
January 10, 2019
by Robert Fenton
How to Implement a Document Management Process in the Age of HIPAA
Paper-Based
January 8, 2019
by Robert Fenton
What's the Best Quality Management Software? We Reviewed 6 Platforms
eQMS
January 3, 2019
by Robert Fenton
Understanding the Growing Need for Product Compliance Software in the Life Sciences Industry
iso9001
December 20, 2018
by Robert Fenton
The Risks of ISO 9001 Nonconformance (And How It Impacts Your Organization)
Pharmaceutical
December 18, 2018
by Robert Fenton
The Essential Tools You Need to Achieve Total Compliance in the Pharmaceutical Industry
Pharmaceutical
December 12, 2018
by Robert Fenton
The Key to Future-Proofing Pharma Compliance
Quality-Driven
December 5, 2018
by Robert Fenton
Quality Management In Healthcare: 5 Things to Expect in 2019
eQMS
November 29, 2018
by Robert Fenton
13 Bottom Line-Boosting Benefits of a Quality Management System
Quality-Driven
November 27, 2018
by Robert Fenton
Quality Management Consulting: How to Evaluate and Choose the Best Consultant
Paper-Based
November 20, 2018
by Robert Fenton
6 Things to Look for in Quality Management System Software for the Pharmaceutical Industry
Paper-Based
November 15, 2018
by Robert Fenton
QMS Software: 7 Features That Save You Time, Money, and Resources
Pharmacy
March 31, 2018
by Leslie Standridge
FDA Rolls Out New Drug Research and Development Pilot Program
FDA
March 28, 2018
by Leslie Standridge
The Difference Between Premarket Notification 510(k) and Premarket Approval
FDA
March 13, 2018
by Leslie Standridge
Qualio's Quick Guide to FDA Medical Device Classification
Medical Devices
November 13, 2016
by Pat Flanders
9 Ways to Ensure Medical Product Compliance Through Quality
Medical Devices
October 11, 2016
by Pat Flanders
FDA issues draft updated recommendations on submitting a new 510(k) for device modifications
483
October 11, 2016
by Pat Flanders
What should I expect when the FDA comes knocking?
FDA
September 28, 2016
by Pat Flanders
Pharmaceutical Testing, Training, Documentation Updates from the FDA
iso9001
September 28, 2016
by Pat Flanders
5 Ways that a QMS Improves ISO 9001 Management
Process
September 20, 2016
by Pat Flanders
The Keys to Successful Life Sciences Product Development
Ireland
September 12, 2016
by Pat Flanders
Qualio Among Fastest Growing Irish Companies
Medical Devices
September 7, 2016
by Pat Flanders
FDA Provides Wellness Device Testing Guidelines. What's Your Next Move?
Compliance
September 1, 2016
by Pat Flanders
Too Late for a QMS: Theranos' Ignoring FDA Compliance Will Cost it Billions
Case Studies
August 16, 2016
by Anoop Aulakh
Case Study: eHealth Technologies SOC 2 Type II Certification
Quality-Driven
May 27, 2016
by Anoop Aulakh
Life Sciences Conferences for Quality Managers to Attend
Case Studies
April 27, 2016
by Damien Barry
How to Rock ISO 13485, Cardiaccs Did It 2x Faster with Qualio
Updates
October 31, 2015
by Robert Fenton
We’re changing our name from ZenDoc to Qualio
eQMS
November 18, 2014
by Nancy Watts
If it’s not documented, it didn’t happen
Updates
October 30, 2014
by Robert Fenton
Qualio is the Digital/Online Startup of the Year
Updates
June 23, 2014
by Robert Fenton
Taking Qualio Quality Management Software from a concept to reality
Business
May 6, 2014
by Robert Fenton
This Will Save Us Years – Lean LaunchPad for Life Sciences
Document Control
April 28, 2014
by Dr. Christopher Devine
Failure to Comply - Document Control in a Regulated Industry
Business
February 21, 2014
by Robert Fenton
Reinventing Life Science Startups – Evidence-based Entrepreneurship
Business
January 15, 2014
by Robert Fenton
Reinventing Life Science Startups – Medical Devices and Digital Health
Business
November 19, 2013
by Robert Fenton
Reinventing Life Science Startups – Therapeutics and Diagnostics
Updates
September 17, 2013
by Robert Fenton
Qualio secures its 1st US partner
Q
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