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eQMS
August 4, 2020 by Robert Fenton

5 Secrets to Securing Medical Device Venture Capital

Medical Devices
July 28, 2020 by Robert Fenton

What's the Difference Between a Class I and Class II Medical Device?

Medical Devices
July 21, 2020 by Robert Fenton

An ISO 13485 Risk Management Plan Example You Can Steal and Use

Quality-Driven
July 16, 2020 by Robert Fenton

Qualio Secures Series A Funding

Compliance
July 14, 2020 by Robert Fenton

A Printable 21 CFR Part 11 Compliance Checklist to Follow Step-by-Step

Medical Devices
July 9, 2020 by Robert Fenton

What's the Best 21 CFR Part 11 Compliant Software in 2020?

iso9001
July 7, 2020 by Robert Fenton

The Risks of ISO 9001 Nonconformance (And How It Impacts Your Organization)

Certification
July 2, 2020 by Robert Fenton

How to Get a Quality Management Certification in 5 Simple Steps

Medical Devices
June 30, 2020 by Robert Fenton

5 Essential Tasks to Include in Your EU MDR Checklist

Medical Devices
June 25, 2020 by Robert Fenton

The 5 Best ISO 14971 Training Programs

eQMS
June 23, 2020 by Robert Fenton

5 Steps of a Quality Management Plan for Distributed Life Sciences Companies

Medical Devices
June 18, 2020 by Robert Fenton

5 Online Medical Device Design Control Templates

Medical Devices
June 16, 2020 by Robert Fenton

10 Impressive Medical Device Startups to Watch in 2020

Medical Devices
June 10, 2020 by Robert Fenton

How to Build the Best Quality Assurance Plan for Distributed Medical Manufacturers

Quality Systems
May 28, 2020 by Robert Fenton

The 5 Best Pharmaceutical Quality Systems Changing Life Sciences in 2020

Medical Devices
May 21, 2020 by Robert Fenton

The Top Medical Device Trends in 2020

eQMS
May 14, 2020 by Robert Fenton

5 Pharmaceutical Manufacturing and Quality Management Trends

Pharmaceutical
May 7, 2020 by Robert Fenton

The 4 Phases of Clinical Trials (And How to Guarantee Quality Assurance During Every Step)

Medical Devices
April 30, 2020 by Robert Fenton

4 FDA Medical Device Reporting Procedures for Life Science Companies

Medical Devices
April 28, 2020 by Robert Fenton

4 Medical Device Manufacturers Revolutionizing Life Sciences in 2020

Medical Devices
April 27, 2020 by Robert Fenton

Qualio Named Top Performer in the Spring 2020 Quality Management Software Customer Success Report

FDA
April 22, 2020 by Robert Fenton

A Complete Overview of the FDA 510(k) Process (And How to Shorten It)

eQMS
April 16, 2020 by Joe O'Reilly

Single Sign-On With SAML2 Now Available for Qualio

eQMS
April 15, 2020 by Robert Fenton

How to Set Up an ISO 14971 Risk Matrix in 5 Simple Steps

Medical Devices
April 8, 2020 by Robert Fenton

How to Build an FDA Audit Strategy During the COVID-19 Pandemic

Medical Devices
April 1, 2020 by Robert Fenton

The Medical Device Startup Process: Avoid These 7 Deadly Missteps

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 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

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 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 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

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 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

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
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
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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