All "Medical Devices" articles

The TGA's essential principles explained

The complete guide to passing ISO 13485 audits

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 ...

25 impressive medical device startups to watch in 2023

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

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

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 ...

The top 7 medical device consulting firms you should consider for 2023

Which are the top medical device consulting firms your business should look at as we approach 2023? The right consultant expertise can speed up your ...

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

8 best ISO 13485 training programs in 2023

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

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 ...

Everything you need to know about ISO 13485

The FDA's plans to harmonize FDA 21 CFR Part 820 and ISO 13485 explained

The United State Federal Drug Administration (FDA) plans to present a draft revision of its Quality System Regulation— FDA 21 CFR 820—that brings it ...

How to manage nonconformances in medical devices

It's important for medical device manufacturers to have a clear understanding of nonconformances—often referred to as NCs—and how to properly manage ...

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 ...

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 ...

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 ...

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 ...

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 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 ...

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 ...

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 ...

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). ...

Everything You Need to Know About Design Controls for Medical Devices

Navigating the medical device regulatory environment can seem daunting at times, and it's easy to get lost in the technical jargon of the standards. ...

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 ...

How Much Is the FDA Medical Device Registration Fee in 2022?

For the fiscal year of of 2022, the Food and Drug Administration (FDA) medical device registration fee rates increased by 2.5% from 2021. Considering ...

What all medical device founders should know with John Kapitan, CEO of Kapstone Medical

Subscribe on any major podcast player. Today's guest, John Kapitan is the CEO of Kapstone Medical, a company he founded in 2007 after 15 years in the ...

What is FDA Emergency Use Authorization

In recent months, the U.S. Food and Drug Administration (FDA) has used Emergency Use Authorizations (EUA) to accelerate the development and approval ...

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 ...

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 ...

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 ...

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 ...

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

If you’re preparing to introduce a new medical device to market, labelers must first secure a unique device identifier. In case you’re unfamiliar, ...

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 ...

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 ...

What is the Global Unique Device Identification Database (GUDID)?

The U.S. Food and Drug Administration (FDA) created the Global Unique Device Identification Database (GUDID) as a labeling resource for medical ...

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. ...

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 ...

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 ...

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 ...

4 Major Class II Medical Device Requirements

Many growing startups and scale-ups deal with non-compliance issues at one point or another. Listen to the audio version of this article read by a ...

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

What does it take to deliver maximum quality assurance? The most effective medical device manufacturers commit to quality-driven processes and ...

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 ...

5 FDA Pre-Submission Tips for Medical Device Manufacturers

You've just designed the greatest medical device of all-time. Now what? If you've developed a medical device similar to one that's already available ...

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 ...

5 Medical Device Supplier Innovations in 2020

Medical device suppliers have unveiled some amazing innovations this year. Failing to keep tabs on these advancements could keep you from growing ...

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 ...

4 Medical Device Manufacturers Revolutionizing Life Sciences in 2020

This year, medical device manufacturers are rising to the COVID-19 challenge by developing innovative new products. For example, industry leaders ...

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 ...

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 ...

5 Essential Tasks to Include in Your EU MDR Checklist

Is your life science organization working toward EU Medical Device Regulation (MDR) readiness? If you are a manufacturer, authorized representative, ...

The 5 Best ISO 14971 Training Programs

Are you up to date on the latest ISO 14971 developments? ISO 14971 is the application of a risk management process for medical devices. The third ...

5 Online Medical Device Design Control Templates

Errors in design control can cause major issues for medical device companies. In fact, according to recent reports, the leading causes of product ...

The Top Medical Device Trends in 2020

Is your life sciences company primed for growth? By adopting the latest medical device trends, your organization can achieve significant growth, ...

Qualio Named Top Performer in the Spring 2020 Quality Management Software Customer Success Report

Qualio has been named a Top Performer in the Quality Management Software category for the Spring Customer Success Report published by ...

How to Build an FDA Audit Strategy During the COVID-19 Pandemic

The COVID-19 Pandemic is causing businesses everywhere to have to make changes to the way they operate. While some industries are more impacted than ...

The Medical Device Startup Process: Avoid These 7 Deadly Missteps

Did you know that seven new startups will launch in the time that it takes you to read this blog post? Unfortunately, four of those startups will ...

International Medical Device Regulations vs FDA 21 CFR: 4 Crucial Differences

Maintaining international regulatory standards is a real challenge, even for the most astute medical device organizations. Recently, the FDA issued a ...

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

Let me tell you the secret to turning your medical device company into the market leader in your category: You have to build a quality-driven ...

7 Medical Device Conferences to Get You Ready for EU MDR

Are you worried that some obscure clause in the new EU MDR standard will trip your company up? Is the push to meet the deadline stressing your team ...

Design Controls for a Medical Device: 5 Secrets for Success

As you know, designing a new medical device can be exhilarating. However, if you get caught up in the excitement and fail to properly document your ...

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. ...

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

Listen to the audio version of this article read by a real person here (Sound on!): The medtech industry is in a constant state of flux. Medical ...

Medical device quality assurance and regulatory compliance in 2023: what you should know

Maintaining an edge means staying ahead of the competition and regulatory bodies when it comes to medical device quality assurance and regulatory ...

Reviewing the Best Medical Device Risk Management Consultant Options for 2020

Uncertainty breeds anxiety. And medical device manufacturers have plenty of reasons to be anxious. The current device risk climate has caused ...

What To Consider When Choosing Quality Management Software (eQMS) for Medical Devices [8 Factors]

You already know that your current quality management system is hurting your medical device company — but how do you pick the right replacement? Your ...

Reviewing the Top Medical Device Quality Software Options for 2020

Times are changing and it’s getting harder and harder to keep up with ever-changing regulations using a paper-based quality management system. If ...

How Much Does Medical Device Regulatory Consulting Cost in 2020?

How much do medical device regulatory consulting firms charge? That's the first question to ask when trying to answer the bigger question, "Are they ...

5 Staggering Medical Device Recall Statistics That Should Concern Everyone

Faulty medical devices not only endanger patient lives, they can also mean the death of your organization. Take the A.H. Robins company, for ...

5 Common Medical Device Regulatory Compliance Problems Faced in 2020

Is the thought of achieving and maintaining regulatory compliance stressing you out? It's a good thing that our friends in the pharmaceutical ...

How to Shrink the FDA Medical Device Approval Timeline

What would the impact be if you could shave 30 days or more off your FDA medical device approval timeline? How much sooner could you bring your ...

Preclinical Testing of Medical Devices: 7 Essential Steps to Prepare

There are two very good reasons to get through the medical device regulatory approval process as quickly as possible: Profitability of your company ...

Is Your eQMS Built for ISO 14971 Risk Management Compliance?

Clearing the ISO 14971 risk management standard can be a pain without the right tools in place. One of the most difficult challenges to hurdle is ...

The 6 Best Medical Device Regulatory Consulting Services in 2020

Your industry is highly competitive, and your products are literally changing lives. Getting your medical devices to market quickly has to be a top ...

9 Ways Canadian Medical Device Regulations Differ From the US

Are you considering expanding your medical device sales to Canada? Will passing Canadian regulations to market and sell your product be too ...

4 Regulations That Apply to Medical Device CRO Selection

Bringing a medical device to market is an intense process filled with due diligence, engineering, and a lot of red tape. There are many steps in the ...

The Pros and Cons of Medical Device Consulting

Bringing a new medical device to market is not an easy process. To get this far, you’ve already made a significant investment in time and resources, ...

FDA Audit: Medical Device Companies Should Watch Out for 7 Mistakes

If you’re losing sleep to nightmares about an unannounced FDA raid on your company, then it’s time to get proactive. You should be prepared for an ...

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

With the clock winding down, what does this new Medical Device Regulation (MDR) mean for you if you have previously approved devices or if you’re ...

Evaluating Contract Sales Organizations for Medical Device Companies

Has your medical device company hit a sales slump? It can be hard to focus on building your sales team when you’re testing a new market or getting ...

Which Conformity Assessment Should Med Device Companies Choose

As a medical device company, you have more regulations and burdens than businesses in most other industries. You have an intense number of rules that ...

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

Are you worried that passing FDA regulations for your medical device are going to slow time-to-market and cause your team massive headaches? Speed to ...

4 Reasons Overhauling FDA 510(k) is a Great Move

Recent high-profile failures of medical devices have caused harm and injury to patients while damaging the FDA and medical device industry's ...

How to Clear the 21 CFR 820.50 Hurdle in 7 Easy Steps

In 2017, the FDA cited 3,515 observations for 21 CFR 820 and sent 138 warning letter citations for 21 CFR 820.50. That means that somewhere during ...

9 Ways to Ensure Medical Product Compliance Through Quality

In our work with medical device product developers and manufacturers, we know quite well the stress that comes with scrutiny of regulatory ...

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

Last month, the US Food and Drug Administration (FDA) released a document that provides guidelines and compliance information for companies that ...