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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

Qualio Among Fastest Growing Irish Companies

By Pat Flanders
Sep 07, 2016 • 1 min read
Medical Devices, FDA

FDA Provides Wellness Device Testing Guidelines. What's Your Next Move?

By Pat Flanders
Sep 01, 2016 • 3 min read
Compliance

Too Late for a QMS: Theranos' Ignoring FDA Compliance Will Cost it Billions

By Pat Flanders
Aug 16, 2016 • 4 min read
Case Studies, Digital Health, Audit, SOC2 Type II

Case Study: eHealth Technologies SOC 2 Type II Certification

By Anoop Aulakh