All articles from Robert Fenton

How to choose ISO 13485 QMS Software in 2024

6 strategies for successful biotech funding

ISO 13485 vs. ISO 9001: understanding the key differences for medical devices

Qualio donates 1% of revenue to charity for a third consecutive year

5 tips for quality management compliance

2023 is nearly here. Time to reflect on another successful year!

How to start a pharmaceutical company

6 biotech incubators for startups in the U.S.

Qualio: officially Best Place To Work!

Empowering Women With Personal Fertility Knowledge with Dr. Amy Beckley of MFB Fertility

The 4 Best Medical Device Quality Assurance Training Options

Qualio as a Force for Good: Year 2 of Improving Healthcare Access for Vulnerable Populations

4 Examples of Continuous Improvement in Quality Management in Life Sciences Companies

Rapidly Discovering and Extracting Natural Pharmaceuticals

How Long Does the FDA Medical Device Approval Process Take? [Timeline]

Launching the First Single-use Endoscope for Unsedated Pediatric Endoscopy with Dr. Heather Underwood, CEO of EvoEndo

Announcing Qualio's $50M Series B Funding Round

How to Get Non-Dilutive Funding via Federal Agencies

What are the best pharmaceutical quality assurance courses online?

How A Document Control System Can Transform Your Business [7 Benefits]

5 Essential Elements of Quality Management Software

Improving Healthcare Access for Vulnerable Populations

From Hippie to Med School to Entrepreneur with Dr. Hana, MD

Does an FDA Class 1 Medical Device List Exist?

What Are the Objectives [5 Examples] of Quality Assurance in the Pharmaceutical Industry?

FDA to Issue New Guidance on QMS Validation: 4 Major Changes

5 Major IEC 62304 Compliance Mistakes Medical Software Manufacturers Make

The ISO 13485 Checklist for Medical Device Manufacturers

Understanding Risk Classification of Medical Devices: 3 Major Grades

The 5 Best Medical Device Product Lifecycle Management Tools

What is eQMS Software Validation?

What Are The Top FDA Software Validation Requirements? [Review]

Top 7 Biotech Investors Changing the Life Science Industry

5 Essential Elements of a QMS for Medical Devices

4 FDA Medical Device Reporting Procedures for Life Science Companies

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

How to Get a Quality Management Certification in 5 Simple Steps

5 Essential Tasks to Include in Your EU MDR Checklist

The 5 Best ISO 14971 Training Programs

5 Online Medical Device Design Control Templates

5 Pharmaceutical Manufacturing and Quality Management Trends

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

6 Best Practices from Six Sigma that Medical Device Companies Should Follow

Design Controls for a Medical Device: 5 Secrets for Success

7 ISO 13485:2016 Changes That Can Make Your Company Better

Medical Device Consultant Rates for 2020: What You Should Get for Your Investment

Reviewing the Best Medical Device Risk Management Consultant Options for 2020

Medical Device Compliance Consulting: 11 Questions to Ask Before Hiring

How Much Does Medical Device Regulatory Consulting Cost in 2020?

5 Staggering Medical Device Recall Statistics That Should Concern Everyone

6 Signs Your Quality Management Process Is Failing

5 Common Medical Device Regulatory Compliance Problems Faced in 2020

The Top 4 ISO 13485 Gap Analysis Templates: Pros and Cons

The Quality Policy of Pharmaceutical Industry Leaders Includes These 5 Things

How to Shrink the FDA Medical Device Approval Timeline

How to Pass Every Quality Management Audit Without Breaking a Sweat

How to Solve 5 Common Document Control Procedure Problems

Preclinical Testing of Medical Devices: 7 Essential Steps to Prepare

5 Medical Device Compliance Problems That Can Permanently Damage Life Sciences Companies

The 4 Worst Supplier Quality Management Procedure Problems for Life Sciences Organizations

The 6 Best Medical Device Regulatory Consulting Services in 2020

9 Helpful Document Control Tips You Can Implement Right Now

ISO Compliance: The What, Why, and How for Life Sciences Companies

9 Ways Canadian Medical Device Regulations Differ From the US

What's the Best Corrective Action Database Software?

Product Realization ISO 13485 In Layman's Terms

4 Regulations That Apply to Medical Device CRO Selection

The Pros and Cons of Medical Device Consulting

The EU Med Device Regulation Timeline: What You Should Know in 2020

Evaluating Contract Sales Organizations for Medical Device Companies

Which Conformity Assessment Should Med Device Companies Choose

Who’s the Best FDA Consultant for Medical Device Manufacturers?

The Essential Parts of an ISO 13485 Medical Device QMS

Quality vs. Compliance: These 5 Questions Will Determine Your Focus

What Are The 4 Reasons You Need An Agile QMS? (And The Easiest Way to Get One)

What An ISO 13485 Quality Manual For Medical Devices Should Look Like

What You Need To Know About Part 11 Compliant Document Management Systems? (Top 4 Providers)

The Top 5 Cloud-Based Quality Management System Options for 2020

How to Achieve Effective Quality Assurance

Essential Tools to Achieve Compliance in the Pharmaceutical Industry

13 Bottom Line-Boosting Benefits of a Quality Management System

How to Evaluate and Choose the Best Consultant

QMS Software: 7 Features That Save You Time, Money, and Resources