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Medical Devices

• May 01, 2024

The 9 top medical device consulting firms you should consider for 2024

Which are the top medical device consulting firms your business should look at for your 2024 plans? The right consultant expertise can speed up your ...

• May 01, 2024

The top 8 pharmaceutical consulting firms you should consider for 2024

Thinking of working with a pharmaceutical consulting firm in 2024? The right consultant team can slice your time to market, help you embed lasting ...

Quality Systems

• April 17, 2024

Life Sciences Quality Management System: 5 Must-Have Features & Functionality

The right life sciences quality management system (QMS) can put your organization in a position to get to market quickly, scale fast, breeze through ...

Industry Awards

• April 02, 2024

Catalyst Awards 2024: the 17 most exciting life science start-ups and scale-ups to watch this year

• March 22, 2024

How to get an ISO 17025 certification

ISO 17025 certification is the international quality benchmark for the modern testing and calibration laboratory.

Medical Devices

• March 22, 2024

Everything you need to know about ISO 13485

• March 21, 2024

9 core elements of a quality management system [Examples]

Every life science company knows that quality is of the utmost importance. But defining quality and aligning that definition to regulations requires ...

Medical Devices

• March 20, 2024

The 13 Essentials of a Quality Plan for Medical Device Companies

A medical device quality plan is not only required by the FDA and the ISO 13485 framework, but it can help you build quality into your product and ...

Medical Devices

• March 20, 2024

14 medical device quality management system requirements for regulatory compliance

Every day, three medical device quality managers open a piece of mail they will never forget. And these letters aren’t unforgettable in a good way. ...

• March 18, 2024

What to look for in quality management consulting services in 2024

Looking for more information about making the right decision around quality management consultant? Do you how much your company spends on the cost of ...

• March 14, 2024

Reinventing eQMS document management (and more!) in our biggest product release yet

• March 14, 2024

What's the best eQMS software in 2024?

• March 13, 2024

How to choose ISO 13485 QMS Software in 2024

For medical device companies looking for quality management system (QMS) software in 2024, evaluating solutions based on ISO 13485 can offer numerous ...

Medical Devices

• March 12, 2024

25 impressive medical device startups to watch in 2024

As history has shown, it only takes one ground-breaking medtech startup to change a product category forever.

• March 04, 2024

How to choose CAPA software in 2024

Document Control

• March 01, 2024

What to know about document control software in 2024

Document Control

• March 01, 2024

The best document management software for life sciences [reviews]

• January 31, 2024

Starting 2024 with more G2 success

• January 08, 2024

Top 10 conferences for life science companies in 2024

Quality Systems

• January 05, 2024

How to solve the four most common quality management issues in 2024

• January 05, 2024

Pharmaceutical quality management software (QMS): our top picks for 2024

Medical Devices

• January 05, 2024

8 best ISO 13485 training programs in 2024

The caliber of your organization’s ISO 13485 training has a significant impact on the success and effectiveness of your quality programs. In fact, ...

Quality management

• January 05, 2024

What Are The 7 best online quality management training courses for 2024?

• January 05, 2024

What are the 5 best options for nonconformance management software in 2024?

• January 05, 2024

A comprehensive review of the best 21 CFR Part 11 software in 2024

There are multiple 21 CFR Part 11 software providers that can help you meet the requirements of the FDA's electronic record regulations. But a ...

Medical Devices

• January 05, 2024

How Much Is the FDA Medical Device Registration Fee in 2024?

For its fiscal year of 2024, stretching from October 1 2023 through September 30 2024, the Food and Drug Administration (FDA) medical device ...

Medical Devices

• January 02, 2024

QMSR: the FDA's plans to harmonize FDA 21 CFR Part 820 and ISO 13485 explained

The ISO 13485 vs 21 CFR 820 binary has posed a key quality challenge for American medical device manufacturers for a long time. But now that ...

• December 07, 2023

Making work even easier for our customers in our November Launch Train

• December 01, 2023

Top pharma conferences in 2024

Quality Systems

• November 22, 2023

The ultimate guide to pharmaceutical quality assurance

Quality management

• November 16, 2023

5 tips for planning your quality management budget in 2024

• November 08, 2023

6 strategies for successful biotech funding

The biotech industry is booming. After a slight dip in the days of COVID, funding in biotech has ultimately skyrocketed. A McKinsey article found ...

• November 07, 2023

Understanding the major pharmaceutical regulations you need to know

Pharmaceuticals offer a critical, often life-saving capability to patients across the globe. For that reason, pharmaceutical regulations are an ...

• November 02, 2023

I'm Qualio's chief product officer. Here's what the future of our software looks like.

• November 01, 2023

Good distribution practice: understanding GDP compliance

• October 23, 2023

8 ways to fail an ISO audit in 2024

A common word of encouragement you'll hear from colleagues when they find out that you're facing an ISO audit: "Good luck!" Of course, luck isn't a ...

• October 16, 2023

How much does ISO 9001 certification cost?

For quality-focused organizations, ISO 9001 certification cost is a critical and unavoidable hurdle to overcome.

• October 13, 2023

Everything you need to know about the FDA 510(k) submission

What is an FDA 510(k) submission - and how do we complete one?

• October 05, 2023

2024 guide to pharmaceutical software

• September 28, 2023

5 things we learned at the PDA/FDA Joint Regulatory Conference 2023

• September 13, 2023

Best life science vendor, best usability, best set-up, best results! Qualio at G2 Fall 2023

• August 10, 2023

Fresh features and time-saving shortcuts in our latest product release

• August 09, 2023

PMA submissions: 4 PMA application methods for medical devices

• July 20, 2023

Guide to 21 CFR Part 11 compliance [free checklist]

• July 19, 2023

PMA meaning: understanding FDA pre-market approval

• July 11, 2023

What is GxP in pharma?

• July 03, 2023

The ultimate ISO 9001 overview: quality management systems

• July 03, 2023

21 CFR Part 820: the complete overview

• June 30, 2023

Guide to ICH E6 (R3): changes and preparation

Quality management

• June 26, 2023

The hidden costs of a free quality management system

• June 23, 2023

Summer of customer love: more Qualio accolades at the G2 Summer Awards

• June 21, 2023

What is ICH E6 R2? Good clinical practice explained

• June 15, 2023

What is ISO 15189? A complete overview

• June 14, 2023

Powerful quality analytic insights in our latest product launch

Quality management

• June 09, 2023

What is quality assurance?

• June 06, 2023

5 fundamentals of the CAPA quality process

The CAPA quality process, in a nutshell, consists of the specific improvements a regulated organization makes to its processes to eliminate defects ...

Medical Devices

• May 24, 2023

The TGA's essential principles explained

• May 17, 2023

What you need to know about ICH Q8

• May 15, 2023

ICH Q9 quality risk management: an introduction

Medical Devices

• May 10, 2023

The complete guide to passing ISO 13485 audits

Medical Devices

• April 26, 2023

Top 6 conferences in Australia for life science companies in 2023

As Australia emerges as a vibrant, expanding market for the life science industry, we've turned our eyes towards some of the key industry events ...

• April 26, 2023

What you need to know about FDA 21 CFR Part 211

• April 21, 2023

What you need to know about FDA 21 CFR Part 210

• April 19, 2023

Faster access to your quality landscape with our latest product upgrades

• April 18, 2023

Ernie Wallerstein, Jr., CEO of Mental Health Technologies

How can technology be used to treat - and even model and predict - mental health? Ernie Wallerstein, CEO of Mental Health Technologies, thinks he has ...

• April 14, 2023

Spring in our step at the G2 Spring Awards 2023

• April 14, 2023

Guide to GxP compliance: processes, challenges and tools

• April 05, 2023

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

• April 05, 2023

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

Lifesaving drugs only work 50% of the time. The reason? Broad-stroke treatments that gloss over the individual variations in our bodies. For Dr. Mo ...

Quality Systems

• March 16, 2023

Mastering quality management in laboratory environments: 12 essential techniques for 2024

• March 14, 2023

What is cGMP in the pharma industry? 7 experts explain

• March 07, 2023

What is an ICH Q10 pharmaceutical quality system?

• March 03, 2023

5 secrets to securing medical device venture capital in 2023

Medical Devices

• February 24, 2023

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

• February 17, 2023

5 notorious compliance issues in the pharmaceutical industry

Does the prospect of getting an FDA 483 letter keep you up at night? You’re certainly not alone. Compliance pressures in pharma have never been ...

Medical Devices

• February 07, 2023

The 7 best medical device consultants to work with in 2023

Hiring an experienced medical device consultant in 2023 can streamline even your most complicated go-to-market projects and help you jump challenging ...

Quality management

• February 03, 2023

What is a quality management system (QMS)?

• January 30, 2023

510(k) submission checklist to get your medical device to market

• January 25, 2023

The 3 FDA medical device classes: differences and examples explained

Computerized System Assurance

• January 19, 2023

Complete guide to computer system validation in 2024

• January 19, 2023

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

• January 18, 2023

5 tips for quality management compliance

Document Control

• January 18, 2023

We just launched the best native document editor on the eQMS market

If documents are the lifeblood of your quality management system, then easy and logical document creation is the beating heart. Other eQMS platforms ...

• January 16, 2023

Complete guide to the MDSAP's nonconformity grading system

• January 12, 2023

When to submit a 510(k) vs. a Premarket Approval

Quality management

• January 04, 2023

5 benefits of a quality management system (QMS) in 2024

Implementing a quality management system (QMS) can offer noticeable benefits to your entire organization. Recognizing and communicating these ...

Medical Devices

• December 22, 2022

The 6 most common triggers for FDA 21 CFR 820 non-compliance in 2022

• December 20, 2022

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

The future of healthcare depends on fast, targeted and effective treatment. And for that, rapid diagnostics are indispensable. We invited Mehdi ...

• December 15, 2022

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

Industry Awards

• December 14, 2022

Qualio smashes customer review records at G2 Winter 2023 Awards

Product Updates

• December 12, 2022

Even faster and easier training with Training Plans

Keeping your colleagues up-to-date with role-specific training is vital for any life science business. And for Qualio customers, keeping up with your ...

• December 12, 2022

510(k) exempt medical devices: how to tell if you need to submit

• December 09, 2022

Modernizing the Lab with Nathan Clark Cofounder of Ganymede

What does a modern life science lab look like? How much manual data processing will take place? Hopefully very little if Ganymede continues to make ...

• December 06, 2022

How to build a complaint management system

What’s more dreadful than receiving a customer complaint? Being asked by a regulatory auditor how you handled the complaint and if you effectively ...

Medical Devices

• November 30, 2022

What the FDA's new MDDS guidance means for you

The medical device world, like almost every other industry on Earth, gets more digitized by the day. So it's no surprise to see industry bodies like ...

• November 23, 2022

The 5 best pharmaceutical consultants to work with in 2023

Thinking of hiring an experienced pharmaceutical consultant in 2023? The right expert can lift your business to the next level, helping you embed ...

Medical Devices

• November 18, 2022

The 4 best ISO 13485 audit checklists

An ISO 13485 audit can make even the most seasoned medical device quality managers bite their nails. The standard includes 77 clauses, so there are a ...

Product Updates

• November 08, 2022

The next wave of Qualio upgrades arrives

• October 20, 2022

A step-by-step guide to internal quality audits

Gearing up for a quality audit is no small feat. Whether it’s your organization’s first time being audited or the 100th, there’s always room for ...

Computerized System Assurance

• October 19, 2022

Qualio launches new validation approach

• October 05, 2022

The ultimate guide to change control for life sciences companies

For any organization that makes a product, it's important to have change controls in place, but what are change controls? How do they differ from ...

Industry Awards

• September 23, 2022

Qualio takes prizes at the G2 Fall Awards 2022

• September 22, 2022

What are the types of quality audits?

Audits. If you work in life sciences, you know that quality audits are a part of creating life changing products. Though all quality audits aim to ...

Computerized System Assurance

• September 20, 2022

What do the FDA's new CSA guidelines mean?

Medical Devices

• September 19, 2022

Understanding post-market surveillance for medical devices

After spending years developing and testing your medical device, getting it to market is an exciting achievement. But your job isn't done yet. Once ...

Medical Devices

• September 14, 2022

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

When you first embark on building a new piece of furniture, you’re usually holding a small booklet that outlines every part inside your box. Lining ...

Computerized System Assurance

• September 13, 2022

The 10 key changes in the GAMP 5 Second Edition

The GAMP 5 Second Edition, the newest version of the ISPE's computerized system guidance, was released in July 2022, replacing the First Edition ...

• September 09, 2022

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

Ever wondered about your genes and overall health? In today's episode, we will talk about just that with Dr. J Dunn. We go over wholistic kinesiology ...

Medical Devices

• September 01, 2022

Everything you need to know about Design History Files (DHF)

One of the most important things a medical device company can do to help bring products to market quickly is to stay organized. If your team isn't ...

• August 30, 2022

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

21 CFR Part 11 applies to any official quality or manufacturing records pertaining to the design, development, or manufacture of a drug or device ...

Medical Devices

• August 23, 2022

What you need to know about medical device validation

When medical devices work properly, they keep us healthy, moving, monitored, and—in some cases—alive. They're a growing sector in the healthcare ...

• August 16, 2022

How to start a pharmaceutical company

Starting your own business takes time, energy, and money—and if you're building a pharmaceutical startup, there’s even more to consider.

• August 09, 2022

21 CFR Part 11: A guide for clinical trial compliance

When conducting or managing any part of a clinical trial, from pre-study through close-out, compliance with 21 CFR Part 11 is always required. The ...

• August 02, 2022

What is GxP in the life sciences industry?

• August 01, 2022

What is an electronic batch record?

According to a report from the Food and Drug Administration (FDA), more than 400 organizations receive a letter for not complying with standard ...

• July 28, 2022

The pros & cons of pharmaceutical contract manufacturing

Manufacturing a new drug is an expensive process, especially for startups with limited resources. That’s why many biopharmaceutical and ...

Medical Devices

• July 26, 2022

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

Making sure that medical devices meet the required quality standards is essential to protecting public safety. In order to ensure compliance, medical ...

Medical Devices

• July 05, 2022

Medical device quality management system template: 8 powerful options

Starting a medical device company is an immense task. You have plans to make, employees to hire, funding to obtain, and on top of all that, you have ...

• June 30, 2022

6 biotech incubators for startups in the U.S.

The cost of getting a biotech startup off the ground is high. Founders not only need to find the right partners, but they must also consistently ...

Medical Devices

• June 28, 2022

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

This is a guide for medical device professionals looking to gain a deeper understanding of the risk management process and how it may be applied. A ...

Industry Awards

• June 27, 2022

Qualio maintains momentum at the G2 Summer Awards 2022

• June 17, 2022

The 5 best spots in the United States to start a life science company

• June 16, 2022

Biotech vs pharma: Differences and similarities

To laypeople, the words “biotech” and “pharma” might seem interchangeable. But when you understand the difference between biotech vs. pharma, you can ...

Medical Device Start-Up

• June 13, 2022

How to start a medical device company

Medical Devices

• June 09, 2022

A practical guide to implementing Risk Management for medical device startups

Risk Management continues to be a hot topic in the medical device world as regulators place additional emphasis on the role of risk management ...

• May 31, 2022

5 tips for pitching your life science company to investors in 2024

• May 27, 2022

5 ways to make the FDA audit process easier for your life sciences company

Benjamin Franklin once said that two things in life are certain—death and taxes—and if you’re running a life sciences company, add going through the ...

• May 26, 2022

The EU IVDR: everything you need to know (Ultimate Guide)

The In Vitro Diagnostic Regulation (IVDR) (EU) 2017/746, better known as the EU IVDR, goes live today!

• May 19, 2022

Qualio launches triple integration release

Medical Devices

• May 11, 2022

How SaMD companies can use a QMS to improve regulatory compliance

Nearly a decade ago, the International Medical Device Regulators Forum (IMDRF) released its guidelines for Software as a Medical Device (SaMD). ...

• May 10, 2022

Qualio: officially Best Place To Work!

I'm really pleased to announce that Qualio has made the list of Inc. Magazine's Best Workplaces of 2022 with an overall employee satisfaction score ...

• May 06, 2022

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

Today, we have Lyn Yaffe joining us. Lyn is the Co-founder, Chairman, and CEO of EPR-Technologies. EPR Technologies is a biomedical spinoff of the ...

• April 26, 2022

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

It’s stressful to receive an observation or warning letter from the Food and Drug Administration for corrective and preventive action (CAPA) ...

• April 19, 2022

Software as a medical device: Definition, examples, and regulatory trends

Software has “eaten” many industries ever since investor Marc Andreessen penned his famous column ten years ago. And the healthcare industry is no ...

• April 07, 2022

Tips for passing your MHRA inspection

• April 06, 2022

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

Dr. Amy Beckley, founder and CEO of MFB Fertility and inventor of the Proov fertility test joins the show to talk about her journey as a scientist ...

Medical Devices

• March 30, 2022

Everything you need to know about design controls for medical devices

• March 29, 2022

Scaling insulin production with Cameron Owen, CEO/co-Founder of rBio

It's not hard to find someone who has been affected by diabetes and the rising cost of insulin. In fact, today's guest says that 1 in 10 people in ...

Industry Awards

• March 23, 2022

Qualio starts 2022 the right way at the G2 Spring Awards

Qualio has continued to build our successful presence on the technology review platform G2 by placing first in 4 key areas in the Medical QMS ...

Quality Systems

• February 24, 2022

Quality Assurance vs. Quality Control Explained: 5 key differences

• February 22, 2022

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

Paper-based quality management systems have been a mainstay for life sciences organizations. A paper-based approach can be easy to stand up within an ...

• February 03, 2022

The quality manager's guide to rapid eQMS success: validation, adoption and implementation

Electronic quality management systems (eQMS) were generally limited in their infancy to costly, custom on-premise platforms developed specifically ...

Medical Devices

• January 17, 2022

The 4 Best Medical Device Quality Assurance Training Options

Organizations spend $12 billion a year on quality assurance, which seems like a lot until you learn they lose twice that amount on issues related to ...

• January 12, 2022

What Are The Essential Elements of Pharmaceutical Quality Management Systems? [8 Examples]

If you aren’t following current good manufacturing practices (cGMP), ISO standards or ICH Q10 guidance, you’re leaving yourself open to making errors ...

• December 22, 2021

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

• December 16, 2021

Ultimate guide to Qualio integrations

Integrations aren't just about making your life easier and your work faster – though of course that's important.

Document Control

• September 30, 2021

4 Things Pharmaceutical Startups Need for Document Management

Imagine this: your pharmaceutical company is close to receiving full FDA approval for your new drug—but then the FDA comes back to you with multiple ...

Quality Systems

• September 09, 2021

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

We all know that quality management isn't a "set it and forget it system," but how do you actually make continuous improvement in quality management ...

Medical Devices

• August 31, 2021

What is a Device History Record (DHR)? [Definition and Components]

Read below if you would like more information regarding Device History Records and its different components. What is the best way to ensure that your ...

• August 24, 2021

The Risks of ISO 9001 Nonconformance

Concerned about ISO 9001 nonconformance? You're not alone. Almost all organizations receive a nonconformance notification at some point. The question ...

Medical Devices

• August 19, 2021

What are the 6 Essentials of a Clinical Evaluation Report (CER) for Medical Device Organizations?

Listen to the audio version of this article read by a real person here (Sound on!): If you've never completed a medical device clinical evaluation ...

Medical Devices

• August 17, 2021

What is the Device Master Record (DMR)?

The 21 CFR 820.181 regulation requires all medical device manufacturers to maintain concrete records related to device specifications, quality ...

• August 12, 2021

How to respond to FDA warning letters

What’s the fastest way to ruin a quality manager’s day? Receiving a warning letter from the United States Food and Drug Administration (FDA). ...

Medical Devices

• August 10, 2021

3 FDA Design Control Requirements for Medical Device Startups

Did you know that design issues are the largest source of product recalls in the United States? Poorly designed products pose a serious threat to ...

• August 05, 2021

Rapidly Discovering and Extracting Natural Pharmaceuticals

Subscribe on any major podcast player. Mental health issues have been on the minds of many as athletes are under tremendous pressure to perform ...

Medical Devices

• July 27, 2021

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

How long before your medical device startup runs out of money? That depends on how long it takes before you start generating revenue. And generating ...

• July 22, 2021

Identifying the 4 Most Common Problems With Your CAPA Process

Over the years, we’ve heard from thousands of life sciences start-up founders and quality managers. As an industry-leading quality management system ...

• July 20, 2021

5 Major Total Quality Management Principles for Medical Device Startups

What is total quality management (TQM) as it relates to the life sciences industry? A bulletproof TQM strategy outlines the strategies manufacturers ...

Medical Devices

• July 15, 2021

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

To ensure that products are safe and effective for use, medical device manufacturers need to follow specific guidelines enforced by the U.S. Food and ...

• July 08, 2021

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

Did you know that the biopharmaceutical industry represents some of the most significant achievements in modern science and technology? Listen to the ...

Medical Devices

• July 06, 2021

How to Get IEC 60601-1 Approval in 5 Easy Steps

For some medical device startups and scale-ups, achieving International Electrotechnical Commission (IEC) 60601-1 approval is easier said than done. ...

• June 29, 2021

Qualio now offers industry-leading high availability

Reliable tools are a top priority for life sciences companies. When you’re bringing transformative new drugs, therapeutics, and medical devices to ...

• June 16, 2021

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

Subscribe on any major podcast player. Today’s guest is Dr. Heather Underwood, CEO of EvoEndo. She talks about launching the first unsedated ...

Medical Devices

• June 03, 2021

3 Important FDA Medical Device Guidance Documents to Bookmark

Are you struggling with medical device regulatory compliance? If so, you’re not alone. It’s an issue that thousands of growing medical device ...

• May 25, 2021

Announcing Qualio's $50M Series B Funding Round

When I founded Qualio in 2012, I set out to create a platform that would enable companies to build with quality and speed. In the years since, it's ...

• May 20, 2021

The Top 3 Pharmaceutical Venture Capital Firms

What are the best investment opportunities in the pharmaceutical industry this year? Listen to the audio version of this article read by a real ...

Medical Devices

• May 18, 2021

EU Medical Device Training: 4 Amazing Programs

Today’s most successful organizations commit to continuous learning. It’s what separates industry-leading medical device and pharmaceutical startups ...

• May 13, 2021

What is the ISO 13485 Quality Manual?

Did you know that medical devices are among the most highly regulated products? Some medical devices, including those within Class II and Class III ...

• May 11, 2021

Biopharma Quality Management: 5 Steps to Guarantee Regulatory Compliance

In recent years, the biopharmaceutical industry has experienced an onslaught of regulatory changes. When you consider the total volume of regulatory ...

• May 06, 2021

What is the FDA 21 CFR? Requirements Overview

What is the best way to ensure that your medical device complies with all applicable laws and regulations? Title 21 of the Code of Federal ...

Medical Devices

• May 06, 2021

4 Major Class II Medical Device Requirements

Many growing startups and scale-ups deal with non-compliance issues at one point or another. Unfortunately, failure to meet major medical device ...

• May 04, 2021

How to Prepare for and Pass an Audit – and What to Do Next

Sooner or later, every life sciences, biotech, pharma, or medical device manufacturer will face an audit. Whether that’s a pre-approval inspection, a ...

• April 29, 2021

How to Build a Document Control Procedures Manual

How does your life sciences startup or scale-up manage its documentation? Unfortunately, ineffective document management can result in serious ...

Document Control

• April 20, 2021

5 Amazing Medical Device Document Management Tips

What are the best medical device document management tips to help you improve organization and document procurement? Most growing startups know that ...

• April 06, 2021

How to Master Pharmaceutical QA in 4 Simple Steps

What does it take to master pharmaceutical quality assurance (QA)? The most successful pharmaceutical startups know that QA refers to anything that ...

• March 23, 2021

Qualio Ranks #1 in QMS Usability, Implementation, and Satisfaction on G2

Qualio has achieved the #1 spot in QMS implementation, usability, and momentum based on the responses of real users for each of G2's 2021 Spring ...

• March 17, 2021

How to Get Non-Dilutive Funding via Federal Agencies

Subscribe on any major podcast player. Over $50B (with a B!) is available each year to life science companies from federal agencies. The best part ...

• March 09, 2021

What are the best pharmaceutical quality assurance courses online?

Pharmaceutical quality assurance courses play an important part in keeping your team educated and motivated to make quality assurance a priority can ...

Document Control

• March 04, 2021

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

Last year, the FDA released 476 warning letters including 201 letters about violation of current good manufacturing practices (cGMP) such as document ...

• March 03, 2021

How to maintain and improve quality management while working remotely

• February 09, 2021

CureMetrix helps radiologists make better, faster decisions with AI

• February 01, 2021

Qualio is Officially ISO 9001 Certified!

At Qualio, we’re all about helping life sciences, biotech, pharma, and medical device companies get products to market faster with our robust ...

Medical Devices

• January 14, 2021

5 Major CAPA Medical Device Requirements

The corrective and preventive action (CAPA) quality processes consist of the critical activities life sciences organizations must activate to ...

• December 22, 2020

5 Essential Elements of Quality Management Software

The world's most broadly adopted standard, ISO 9001:2015, includes a series of quality principles that are frequently referenced in other QMS ...

• December 22, 2020

Improving Healthcare Access for Vulnerable Populations

2020 has been an unprecedented year. In times like these, mission-driven companies should challenge themselves to stay focused on their immediate ...

• December 16, 2020

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

Subscribe on all major podcast players: If you have a nose, you should check out this episode. Dr. Hana Solomon, MD shares her journey from hippie to ...

• November 10, 2020

Does an FDA Class 1 Medical Device List Exist?

Understanding where your product falls in FDA classifications can help medical device manufacturers plan for regulatory compliance. If you can find a ...

Quality Systems

• October 20, 2020

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

When quality assurance in the pharmaceutical industry isn't prioritized, the results can be disastrous for the manufacturer and consumer. Imagine ...

• October 15, 2020

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

Are you having difficulty validating a quality management system (QMS)? As you know, validation provides a level of confidence in the software's ...

• October 13, 2020

5 Major IEC 62304 Compliance Mistakes Medical Software Manufacturers Make

The international standard IEC 62304 is a standard that specifies life cycle requirements for the development of medical software. This standard is ...

• October 08, 2020

The ISO 13485 Checklist for Medical Device Manufacturers

Are you preparing for ISO 13485 certification? If so, the process can be overwhelming. Keep reading to learn more about how to make the experience ...

Medical Devices

• September 24, 2020

Understanding Risk Classification of Medical Devices: 3 Major Grades

Did you know that classifying your medical device incorrectly could extend the Food and Drug Administration's (FDA) approval process by months? As ...

Medical Devices

• September 10, 2020

The 5 Best Medical Device Product Lifecycle Management Tools

Picking the right medical device product life cycle management (PLM) tool is a huge deal. Selecting the wrong PLM could lead to headaches and legal ...

• September 03, 2020

What is eQMS Software Validation?

Before we dive into the specifics of electronic quality management system (eQMS) software validation, let's take a step back and briefly discuss why ...

• September 01, 2020

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

Learn about the FDA and its current guidance on General Principles of Software Validation and how it has changed since its initial release date in ...

• August 27, 2020

Top 7 Biotech Investors Changing the Life Science Industry

Is your biotech company looking for funding? If so, you need to find a biotech investor that understands your unique business and industry. Listen to ...

Medical Devices

• August 25, 2020

5 Essential Elements of a QMS for Medical Devices

Are you planning on investing in a Quality Management System (eQMS) for your medical device company? Without careful consideration and planning, a ...

Medical Devices

• August 11, 2020

4 FDA Medical Device Reporting Procedures for Life Science Companies

As you know, medical device reporting procedures can be confusing. The laws are always changing, and your life science company needs to keep up with ...

Medical Device Classification

• July 28, 2020

What's the difference between a Class I and Class II medical device?

Does your medical device fall under the Class I or Class II category? Depending on where you manufacture and sell your products, you'll need to ...

Medical Device Risk Management

• July 21, 2020

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

When it comes to getting regulatory approval, creativity is rarely, if ever, a good thing. Medical device organizations have the opportunity to ...

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