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Lola Furlong

Lola is an ASQ Certified Medical Device Auditor with extensive experience working for large multinational corporations and start-ups across Europe and North America. She works closely with Qualio customers to implement and maintain their eQMS, helping them to achieve their quality goals and bring their product to market efficiently.

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Articles by Lola Furlong

Compliance

If Compliance Is Slowing You Down, Your Regulations Are Not the Problem. Your Model Is.

The medical device industry has accepted a false tradeoff. Here's how the best MedTech companies are rejecting it.

Lola FurlongMay 22, 2026
Quality management

6 Signs You're Going to Break at IND: And Don't Know It Yet

Pre-IND biotech teams often mistake a clean GLP audit for clinical readiness. These six structural warning signs reveal whether your quality system is built for clinical demands or running on heroics before IND exposes the gap.

Lola FurlongMay 18, 2026
Biotech

Episodic vs. Continuous Readiness: Which Operating Model Is Carrying Your Biotech Forward?

Most growth-stage biotech companies are audit-ready. Far fewer are scale-ready. Learn the difference between episodic and continuous readiness — and why it determines your clinical outcomes.

Lola FurlongMay 11, 2026
Medical Devices

Regulation Is Not Slowing Your Medical Device. Your Compliance Architecture Is.

FDA oversight isn't why MedTech product development slows down. Fragmented compliance architecture is. Here's what that costs—and what a better system looks like.

Lola FurlongMay 4, 2026
Medical Devices

Continuous Readiness Is Becoming the New Operating Standard in MedTech

Medical device companies can no longer rely on episodic audit prep. Learn why continuous readiness is becoming the new operating standard in MedTech, and what it means for QMS, FDA inspection readiness, and regulatory timelines.

Lola FurlongApr 6, 2026
Medical Devices

25 impressive medical device startups to watch in 2026

Get the full list of medical device companies who are shaping the industry this year. Wonderful inventions, lifesaving products, and more.

Lola FurlongDec 9, 2025
Pharmaceutical

Pharmaceutical quality management software (QMS): our top picks for 2026

Looking to upgrade your pharmaceutical quality system by investing in QMS software? Use our breakdown comparison guide to make the right choice.

Lola FurlongDec 1, 2025
Quality Systems

Mastering quality management in laboratory environments: 12 essential techniques for 2026

This comprehensive guide explores the 12 essential techniques for quality management in laboratory environments - whether you're a laboratory professional or a quality manager!

Lola FurlongNov 19, 2025
ICH

What is ICH E6 R3? Good clinical practice explained

Get the full overview of ICH E6 (R2), the international standard for good clinical practice, and learn what you need to comply.

Lola FurlongMar 13, 2025
Four areas quality assurance covers: process, product, organization and suppliers
Quality management

Quality assurance vs. quality control explained: 5 key differences

Learn about the key quality assurance vs quality control (QA vs QC) differences, and how to apply both disciplines to your operation.

Lola FurlongJan 13, 2025
52% of business failures come from internally generated problems
Compliance

What is Corrective Action Preventive Action (CAPA)?

Explore the CAPA definition, its importance in quality assurance, and real-world CAPA examples. Learn what CAPA stands for and its role in manufacturing.

Lola FurlongJun 14, 2024
Compliance

The EU AI Act: what to expect

Learn about the upcoming EU AI Act and its implications for life science companies. Get ready for fresh regulatory requirements coming in June 2024.

Lola FurlongMay 8, 2024
ISO 17025

How to get an ISO 17025 certification

Learn how to obtain ISO 17025 certification for your testing or calibration laboratory. Follow these steps and ensure your lab's competence.

Lola FurlongMar 22, 2024
Medical Devices

The 13 Essentials of a Quality Plan for Medical Device Companies

Crafting a quality plan for medical device companies is difficult, and it must contain these 13 essentials if you want to make sure you avoid...

Lola FurlongMar 20, 2024
Medical Devices

8 best ISO 13485 training programs in 2024

Searching for the best ISO 13485 training? These top ISO 13485 training programs will help you improve quality processes at your medical device company.

Lola FurlongJan 5, 2024
ISO 9001

How much does ISO 9001 certification cost?

Are you a life science company chasing ISO 9001 certification? Learn all about the cost of getting ISO 9001 certified.

Lola FurlongOct 16, 2023
ICH

Guide to ICH E6 (R3): changes and preparation

Review the latest GCP guidelines coming in ICH E6 (R3). Learn what's changing and how to prepare your team.

Lola FurlongJun 30, 2023
Pharmaceutical

Top pharmaceutical companies: 5 start-ups to watch in 2024

See our list of the top 5 most exciting pharmaceutical companies landing and expanding in 2023.

Lola FurlongApr 5, 2023
Compliance

5 notorious compliance issues in the pharmaceutical industry

Ensure you don't receive an FDA 483 warning letter. Discover the most common compliance issues in the pharmaceutical industry and review your quality system.

Lola FurlongFeb 17, 2023
Pharmaceutical

The pros & cons of pharmaceutical contract manufacturing

Contract manufacturing organizations can be a great resource for pharmaceutical startups. Here are the pros and cons to consider before working with a CMO.

Lola FurlongJul 28, 2022
Medical Devices

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

Learn everything you need to know about ISO 14971, risk management for medical devices, and how to implement it into your quality management system.

Lola FurlongJun 28, 2022
Pharmaceutical

How to find the best pharmaceutical regulatory consulting services

This is your essential guide to finding the best pharmaceutical regulatory consulting services for your pharma company.

Lola FurlongJan 28, 2020