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All "Medical Devices" articles

Medical Devices
• March 03, 2023

25 impressive medical device start-ups to watch in 2023

  As history has shown, it only takes one ground-breaking medtech start-up to change a product category forever.
Medical Devices
• December 27, 2022

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 ...
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 ...
Medical Devices
• November 22, 2022

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, ...
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 ...
Medical Devices
• November 16, 2022

Everything you need to know about ISO 13485

Have you spent countless stressful hours preparing for ISO 13485 certification? You’re not alone. ISO 13485 is the internationally recognized quality ...
Medical Devices
• November 01, 2022

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 ...
Medical Devices
• October 17, 2022

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 ...
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 ...
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 ...
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 ...
Medical Devices
• July 26, 2022

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

Listen to the audio version of this article read by a real person here (Sound on!): Making sure that medical devices meet the required quality ...
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 ...
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 ...
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 ...
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). ...
Medical Devices
• March 30, 2022

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. ...
Medical Devices
• January 17, 2022

The 4 Best Medical Device Quality Assurance Training Options

Listen to the audio version of this article read by a real person here (Sound on!): Organizations spend $12 billion a year on quality assurance, ...
Medical Devices
• November 24, 2021

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 ...
Medical Devices
• October 22, 2021

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 ...
Medical Devices
• September 21, 2021

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 ...
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 ...
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 ...
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 ...
Medical Devices
• August 03, 2021

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, ...
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 ...
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 ...
Medical Devices
• July 13, 2021

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 ...
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. ...
Medical Devices
• June 29, 2021

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
• June 10, 2021

4 PMA Application Methods for Medical Devices

Choosing the correct Premarket Approval (PMA) method can mean the difference between the success or failure of your growing medical device startup or ...
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 ...
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 ...
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. Listen to the audio version of this article read by a ...
Medical Devices
• March 25, 2021

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 ...
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 ...
Medical Devices
• September 29, 2020

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 ...
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 22, 2020

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 ...
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 ...
Medical Devices
• September 08, 2020

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 ...
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 Devices
• June 30, 2020

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, ...
Medical Devices
• June 25, 2020

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 ...
Medical Devices
• June 18, 2020

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 ...
Medical Devices
• May 21, 2020

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, ...
Medical Devices
• April 27, 2020

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 ...
Medical Devices
• April 08, 2020

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 ...
Medical Devices
• April 01, 2020

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 ...
Medical Devices
• March 17, 2020

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 ...
Medical Devices
• March 12, 2020

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 ...
Medical Devices
• March 10, 2020

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 ...
Medical Devices
• March 03, 2020

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 ...
Medical Devices
• February 13, 2020

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 Devices
• February 11, 2020

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 Devices
• February 06, 2020

Medical Device Quality Assurance and Regulatory Compliance in 2020: 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 ...
Medical Devices
• February 04, 2020

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 ...
Medical Devices
• January 30, 2020

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 ...
Medical Devices
• January 16, 2020

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 ...
Medical Devices
• January 14, 2020

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 ...
Medical Devices
• December 24, 2019

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 ...
Medical Devices
• December 10, 2019

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 ...
Medical Devices
• November 19, 2019

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 ...
Medical Devices
• November 07, 2019

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 ...
Medical Devices
• October 17, 2019

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 ...
Medical Devices
• September 17, 2019

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 ...
Medical Devices
• September 12, 2019

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 ...
Medical Devices
• July 30, 2019

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 ...
Medical Devices
• July 16, 2019

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 ...
Medical Devices
• July 11, 2019

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, ...
Medical Devices
• July 02, 2019

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 ...
Medical Devices
• June 27, 2019

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 ...
Medical Devices
• June 25, 2019

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 ...
Medical Devices
• June 20, 2019

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 ...
Medical Devices
• June 04, 2019

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 ...
Medical Devices
• April 18, 2019

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 ...
Medical Devices
• March 05, 2019

The 6 Most Common Warnings for FDA 21 CFR 820 Noncompliance

In 2017, the FDA issued 218 more warning letters for 21 CFR 820 than they did the previous year. The 21 CFR 820 regulation, which the FDA uses to ...
Medical Devices
• February 27, 2019

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 ...
Medical Devices
• November 13, 2016

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 ...
Medical Devices
• September 07, 2016

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 ...