All articles from Kelly Stanton

Ernie Wallerstein, Jr., CEO of Mental Health Technologies

Enabling the next generation of biomarker discovery with Dr. Mo Jain, CEO of Sapient

Getting treatment to patients faster by focusing on your strengths: with Keith Wood, COO of argenx

What all medtech founders should know: with Duane Mancini, CEO of Project Medtech

What is an ICH Q10 pharmaceutical quality system?

Programming humanity into AI to improve clinical trials with Chuck Rinker, CEO of PRSONAS

Pharmaceutical quality management software (QMS): our top picks for 2023

What is a quality management system (QMS)?

Unlocking scientific data with Mike Tarselli at TetraScience

5 benefits of a quality management system (QMS) in 2023

Taking diagnostics to the future with Mehdi Maghsoodnia, CEO of 1Health

Modernizing the Lab with Nathan Clark Cofounder of Ganymede

8 best ISO 13485 training programs in 2023

From Emergency Medicine to Disrupting EHR Technology with Dr. Brian Fengler, Co-founder of EvidenceCare

Everything you need to know about ISO 13485

Engineering quality in organizations to better meet patient needs with Matt Wictome from Datod Consulting

How Dogs Can Be Used in Research and Science with Kayla Fratt Co-Founder of K9 Conservationists

How to get to market faster with medical device outsourcing with Jeff Barrett, CEO of J-Pac Medical

Qualio launches new validation approach

Using Advanced AI to Curate Individualized Cancer Treatments with Navid Alipour, CEO of AI Med Global

9 core elements of a quality management system [Examples]

The ultimate guide to change control for life sciences companies

Testing a Gene Therapy to Cure HIV & Fundamentally Change Healthcare with Jeff Galvin of American Gene Technologies®

Helping Medical Device Companies Accelerate Launches to Market with CiteMed's Ethan Drower

What is a bill of materials? A guide for medical devices

Product and Software Development for MedTech Solutions with Piotr Zajac, CEO of Untitled Kingdom

Finding Root Causes of Conditions by Looking at Genetics with Dr. J Dunn

21 CFR Part 11: Compliance in the supply chain [Checklist]

21 CFR Part 11: A guide for clinical trial compliance

What is an electronic batch record?

The pros & cons of pharmaceutical contract manufacturing

A complete guide to 21 CFR Part 11 for medical device manufacturers

Home testing for everyone, everywhere with Paul Chapman of Domus Diagnostics

Saving Lives and Early Cancer Detection with David Suhy of Earli

A comprehensive guide to ISO 14971: Risk management for medical devices

Navigating FDA Clearance and Launching a Medical Device with Dr. Heather Underwood of EvoEndo

Biotech vs pharma: Differences and similarities

Entrepreneurship and Representation in Healthcare Technology with Gulé Sheikh

The Benefits of Helmet-Based Ventilation with Aurika Savickaite

How Artificial Intelligence Can Accelerate Drug Discovery and Bridge the Translational Gap with Jo Varshney of VeriSIM Life

Rebuilding Biopharma & Personalized Precision Medicine with Diego Rey Cofounder of Endpoint Health and YC Grad

Catalyzing Chemical Reactions & Scientific Collaboration with Nobel Laureate David MacMillan

The History and Innovation of CPR and EPR with Lyn Yaffe, CEO of EPR Technologies

Accelerating Medtech's time to market with a modern regulatory strategy with James Gianoutsos, Founder of Rimsys

Outsourcing to a contract organization? You still need an eQMS. Here's why.

A guide to writing Corrective and Preventive Action (CAPA) reports

Modernizing the EUMDR Clinical Evaluation Report Process with Ethan Drower Co-founder of CiteMed

Using AI & Virtual Patients to Make Clinical Trials Safe, Affordable, and Scalable with François-Henri Boissel CEO of Novadiscovery

Empowering parents & caregivers to identify toxic stress in children with Bryon Bhagwandin CEO of Recalibrate Solutions

Creating “future proof” antibodies vs. virus variants like Omicron with Ian Chan, co-founder of Abpro

Harnessing Digital Talent to Solve Crises with Courtney Brown from WHO & The Millennial Group

Restoring Hearing Loss with Novel Therapeutics with Laurence Reid CEO of Decibel Tx

Rethinking Your Market Access Strategy with Dinesh Kabaleeswaran, Sr. Dir. of Insights and Advisory at MMIT

Quality Assurance vs. Quality Control Explained: 5 key differences

Tips for moving from a paper-based QMS to an eQMS

European Market Strategy, Acquisitions and Disrupting the Drug Discovery Value Chain with Tanja Dowe from Debiopharm Innovation Fund

Busting myths about eQMS vendors

Changing the Game for Drug Delivery with Robert Niichel, CEO of SmartTab

3 thoughts about quality software integrations

The FDA's approach to digital health technology (DHT) is changing. That's a big deal.

What the FDA's new draft software guidance tells us

4 Things Pharmaceutical Startups Need for Document Management

The Risks of ISO 9001 Nonconformance

What Is the Unique Device Identification (UDI) System and Why Is it Important?

Identifying the 4 Most Common Problems With Your CAPA Process

5 Major Total Quality Management Principles for Medical Device Startups

Regulatory Expectations for Software as a Medical Device (SaMD) Startups

What's the Difference Between Biopharmaceutical vs. Pharmaceutical Startups?

3 Biopharmaceutical Manufacturing Trends to Watch in 2021

The 13 Essentials of a Quality Plan for Medical Device Companies

3 Important FDA Medical Device Guidance Documents to Bookmark

The Top 3 Pharmaceutical Venture Capital Firms

What is the ISO 13485 Quality Manual?

Biopharma Quality Management: 5 Steps to Guarantee Regulatory Compliance

What is the FDA 21 CFR? Requirements Overview

4 Major Class II Medical Device Requirements

How to Build a Document Control Procedures Manual

What Are the 5 Best Document Management Systems [Review] for Life Sciences Companies?

The Best 21 CFR 7 Checklist for Medical Device Startups

5 Amazing Medical Device Document Management Tips

FDA Launches New Biocompatibility Assessment Resource Center

5 Quality Control Procedures for Life Sciences Startups

How to Master Pharmaceutical QA in 4 Simple Steps

4 Major Quality Requirements for Pharmaceutical Companies

The 5 Most Important Quality Equipment for Life Sciences Startups

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

Is Your Client Ready for the EU MDR Deadline?

How to Solve the Four Most-Common Quality Management Issues? (2022)

Qualio is Officially ISO 9001 Certified!

How to pass an ISO 9001 audit with Qualio

5 Amazing Life Sciences Companies to Watch in 2021

5 Fastest Growing Biotech Startups to Watch in 2021

What to Look for in Quality Management Consulting Services? [4 Factors]

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

Finding the Best Pharmaceutical Regulatory Consulting Services for Your Organization

7 Signs You Need Pharmaceutical Quality Assurance Consulting