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Compliance
08.22.2019
Robert Fenton
Does an FDA Class 1 Medical Device List Exist?
Compliance
08.20.2019
Robert Fenton
Why Did Medical Device FDA 483 Observations Drop 6.2% Last Year?
eQMS
08.15.2019
Robert Fenton
How to Manage the Medical Device Software Development Process in Your eQMS
eQMS
08.13.2019
Robert Fenton
What's the Best Quality Management System Software for the Pharmaceutical Industry?
eQMS
08.8.2019
Robert Fenton
What's the Most Effective Pharmaceutical Quality Management System in 2019?
Compliance
08.6.2019
Robert Fenton
What Are the Differences in the FDA Medical Device Classes?
eQMS
08.1.2019
Robert Fenton
How to Enable Quality Controls in Life Sciences Marketing
Medical Devices
07.30.2019
Robert Fenton
9 Ways Canadian Medical Device Regulations Differ From the US
Medical Devices
07.25.2019
Robert Fenton
6 Essentials of a Clinical Evaluation Report (CER) for Medical Device Organizations
eQMS
07.23.2019
Robert Fenton
What's the Best Corrective Action Database Software?
Medical Devices
07.18.2019
Robert Fenton
Product Realization ISO 13485 In Layman's Terms
Medical Devices
07.16.2019
Robert Fenton
4 Regulations That Apply to Medical Device CRO Selection
Medical Devices
07.11.2019
Robert Fenton
The Pros and Cons of Medical Device Consulting
eQMS
07.9.2019
Robert Fenton
The Anatomy of a Healthy QMS for Life Sciences Companies
Medical Devices
07.2.2019
Robert Fenton
FDA Audit: Medical Device Companies Should Watch Out for These 7 Mistakes
Medical Devices
06.27.2019
Robert Fenton
The EU Medical Device Regulation Timeline: What You Should Know (in 2019)
Medical Devices
06.25.2019
Robert Fenton
6 Ways to Evaluate Contract Sales Organizations for Medical Device Companies
Medical Devices
06.20.2019
Robert Fenton
How To Decide Which Conformity Assessment Medical Device Companies Should Choose
Medical Devices
06.4.2019
Robert Fenton
Who’s the Best FDA Consultant for Medical Device Manufacturers? (Reviews)
Medical Devices
05.30.2019
Robert Fenton
What's the Best 21 CFR Part 11 Compliant Software in 2019?
Medical Devices
05.28.2019
Robert Fenton
The Essential Parts of an ISO 13485 Medical Device Quality Management System
Compliance
05.23.2019
Robert Fenton
How to Ensure Your Quality Management System Processes and Procedures are Compliant in 2019
eQMS
05.21.2019
Robert Fenton
FDA Regulatory Compliance Software: Cloud vs. On-Premises
Medical Devices
05.16.2019
Robert Fenton
An ISO 13485 Risk Management Plan Example You Can Steal and Use
iso9001
05.14.2019
Robert Fenton
The Difference Between ISO 13485 and ISO 9001 for Medical Devices
eQMS
05.9.2019
Robert Fenton
The Best QMS Software: The Pros and Cons of the 5 Top Options
Pharmaceutical
05.2.2019
Robert Fenton
What Is cGMP In The Pharmaceutical Industry? An Expert Roundup
Medical Devices
04.30.2019
Robert Fenton
The 5 Best Medical Device Quality Assurance Training Options
eQMS
04.23.2019
Robert Fenton
The 8 Essential Functions Of CAPA Management Software
Medical Devices
04.18.2019
Robert Fenton
4 Reasons Overhauling FDA 510(k) is a Great Move
Compliance
04.16.2019
Robert Fenton
A Printable 21 CFR Part 11 Compliance Checklist to Follow Step-by-Step
Compliance
04.9.2019
Robert Fenton
Quality vs. Compliance: These 5 Questions Will Determine Your Focus
eQMS
04.4.2019
Robert Fenton
How Much Does eQMS Software Cost?
eQMS
04.2.2019
Robert Fenton
5 of the Best Options for Nonconformance Management Software
eQMS
03.28.2019
Robert Fenton
4 Reasons You Need An Agile QMS (And The Easiest Way to Get One)
Medical Devices
03.26.2019
Robert Fenton
What An ISO 13485 Quality Manual For Medical Devices Should Look Like
eQMS
03.21.2019
Robert Fenton
5 Indispensable Features Of Enterprise Quality Management Software
eQMS
03.19.2019
Robert Fenton
QMS Software: Open Source vs. Subscription? The Pros and Cons
eQMS
03.14.2019
Robert Fenton
4 Part 11 Compliant Document Management Systems You Should Know About
eQMS
03.7.2019
Robert Fenton
6 Essential Qualities of the Best eQMS Systems
Medical Devices
03.5.2019
Robert Fenton
The 6 Most Common Warnings for FDA 21 CFR 820 Noncompliance
Medical Devices
02.27.2019
Robert Fenton
How to Clear the 21 CFR 820.50 Hurdle in 7 Easy Steps
eQMS
02.14.2019
Robert Fenton
The Top 5 Cloud-Based Quality Management System Options for 2019
eQMS
02.12.2019
Robert Fenton
The 9 Core Elements of a Quality Management System
Pharmaceutical
02.7.2019
Robert Fenton
The 8 Essential Elements of Quality Management For Pharmaceutical Companies
eQMS
02.5.2019
Robert Fenton
The 5 Noticeable Benefits of Implementing A Quality Management System
Quality-Driven
01.31.2019
Robert Fenton
What to Look for in Quality Management Consulting Services (And When You Really Need Them)
Pharmaceutical
01.29.2019
Robert Fenton
How to Achieve Effective Quality Assurance Even In the Most Complex Circumstances
eQMS
01.24.2019
Robert Fenton
QMS in Pharma: 3 Safeguards to Ensure You Meet Compliance Guidelines
eQMS
01.22.2019
Robert Fenton
Why Your QMS System Software Isn't Really Guaranteeing Quality
iso9001
01.17.2019
Robert Fenton
What is the Best ISO 13485 Quality Management System Software for 2019?
Document Control
01.15.2019
Robert Fenton
What Is A Document Control System and Why Does it Matter?
eQMS
01.10.2019
Robert Fenton
How to Implement a Document Management Process in the Age of HIPAA
eQMS
01.8.2019
Robert Fenton
What's the Best Quality Management Software? We Reviewed 6 Platforms
eQMS
01.3.2019
Robert Fenton
Understanding the Growing Need for Product Compliance Software in the Life Sciences Industry
iso9001
12.20.2018
Robert Fenton
The Risks of ISO 9001 Nonconformance (And How It Impacts Your Organization)
Pharmaceutical
12.18.2018
Robert Fenton
The Essential Tools You Need to Achieve Total Compliance in the Pharmaceutical Industry
Pharmaceutical
12.12.2018
Robert Fenton
The Key to Future-Proofing Pharma Compliance
Quality-Driven
12.5.2018
Robert Fenton
Quality Management In Healthcare: 5 Things to Expect in 2019
eQMS
11.29.2018
Robert Fenton
13 Bottom Line-Boosting Benefits of a Quality Management System
Quality-Driven
11.27.2018
Robert Fenton
Quality Management Consulting: How to Evaluate and Choose the Best Consultant
eQMS
11.20.2018
Robert Fenton
6 Things to Look for in Quality Management System Software for the Pharmaceutical Industry
eQMS
11.15.2018
Robert Fenton
QMS Software: 7 Features That Save You Time, Money, and Resources
Pharmacy
03.31.2018
Leslie Standridge
FDA Rolls Out New Drug Research and Development Pilot Program
FDA
03.28.2018
Leslie Standridge
The Difference Between Premarket Notification 510(k) and Premarket Approval
FDA
03.13.2018
Leslie Standridge
Qualio's Quick Guide to FDA Medical Device Classification
Medical Devices
11.13.2016
Pat Flanders
9 Ways to Ensure Medical Product Compliance Through Quality
Medical Devices
10.11.2016
Pat Flanders
FDA issues draft updated recommendations on submitting a new 510(k) for device modifications
483
10.11.2016
Pat Flanders
What should I expect when the FDA comes knocking?
FDA
09.28.2016
Pat Flanders
Pharmaceutical Testing, Training, Documentation Updates from the FDA
iso9001
09.28.2016
Pat Flanders
5 Ways that a QMS Improves ISO 9001 Management
Process
09.20.2016
Pat Flanders
The Keys to Successful Life Sciences Product Development
Ireland
09.12.2016
Pat Flanders
Qualio Among Fastest Growing Irish Companies
Medical Devices
09.7.2016
Pat Flanders
FDA Provides Wellness Device Testing Guidelines. What's Your Next Move?
Compliance
09.1.2016
Pat Flanders
Too Late for a QMS: Theranos' Ignoring FDA Compliance Will Cost it Billions
Case Studies
08.16.2016
Anoop Aulakh
Case Study: eHealth Technologies SOC 2 Type II Certification
Quality-Driven
05.27.2016
Anoop Aulakh
Life Sciences Conferences for Quality Managers to Attend
Case Studies
04.27.2016
Damien Barry
How to Rock ISO 13485, Cardiaccs Did It 2x Faster with Qualio
Updates
10.31.2015
Robert Fenton
We’re changing our name from ZenDoc to Qualio
eQMS
11.18.2014
Nancy Watts
If it’s not documented, it didn’t happen
Updates
10.30.2014
Robert Fenton
Qualio is the Digital/Online Startup of the Year
Updates
06.23.2014
Robert Fenton
Taking Qualio Quality Management Software from a concept to reality
Business
05.6.2014
Robert Fenton
This Will Save Us Years – Lean LaunchPad for Life Sciences
Document Control
04.28.2014
Dr. Christopher Devine
Failure to Comply - Document Control in a Regulated Industry
Business
02.21.2014
Robert Fenton
Reinventing Life Science Startups – Evidence-based Entrepreneurship
Business
01.15.2014
Robert Fenton
Reinventing Life Science Startups – Medical Devices and Digital Health
Business
11.19.2013
Robert Fenton
Reinventing Life Science Startups – Therapeutics and Diagnostics
Updates
09.17.2013
Robert Fenton
Qualio secures its 1st US partner
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