All "Medical Devices" articles

What the FDA's 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 ...

The top 10 life science quality assurance consultants to work with in 2024

Life sciences consulting, particularly quality assurance consulting, can offer a transformational kickstart for your life science company. Securing a ...

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 ...

Everything you need to know about ISO 13485

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 ...

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. ...

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.

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, ...

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 ...

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 ...

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 ...

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

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

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). ...

What are design controls in the medical device industry?

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 ...

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 ...

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 ...

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. ...

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. Unfortunately, failure to meet major medical device ...

CAPA for medical devices: examples, procedures, implementation

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 ...

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 ...

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 ...

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 ...

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 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 ...

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 ...

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 ...

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, ...

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 ...