The medical technology market is a large and lucrative one here in the United States. Revenue in the industry was projected to hit over $523 billion in 2022. And within that market, the largest segment is medical devices. Medical devices are hitting a projected market volume of $435.70 billion in the same year. There are many, many types of devices classified as “medical devices” by the FDA. But not all medical devices require clinical trials — only those that are considered to be “high-risk” devices.

Medical devices are classified as high-risk if they are implantable, life-supporting, or used in children. If a medical device is classified as high-risk, it does require clinical trials before it can be marketed to the public. High-risk medical devices must go through 3 phases of clinical trials.

Medical Devices and Clinical Research

So, what is a clinical trial? Clinical trials are research studies that test how well new medical approaches work in people. They are the primary way that scientists learn whether a new medical intervention, like a new drug or medical device, is safe and effective. Without clinical trials, we would not have many of the medical treatments and technologies that we take for granted today.

The need for a clinical trial is determined by how much is known about the medical device and its potential risks and benefits. For new medical devices, there is often little information available. In these cases, a clinical trial may be needed to assess the safety and effectiveness of the device.

Class I medical devices are considered to be low risk. Class II medical devices are considered to be moderate risk. And Class III medical devices are considered to be high risk. Most Class I medical devices do not require clinical trials, but some may require what’s called a “safety and effectiveness study”.

A safety and effectiveness study is a type of clinical research that is sometimes done for Class I medical devices (and sometimes for Class II medical devices). These studies help to explore whether the medical device is safe and effective for its intended use. The results of these studies are used to help make sure that medical devices are as safe and effective as possible.

Class II medical devices usually require clinical trials if they are new or if they are significantly different from other medical devices on the market. Class III medical devices always require clinical trials.

Clinical Trial Phases For Medical Devices

Examples of Class II medical devices and Class III medical devices requiring clinical trials include, but are not limited to, the following:

  • pacemakers
  • defibrillators
  • artificial hearts
  • implantable cardioverter defibrillators (ICDs)
  • heart valves

Class III medical devices are those that support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential, unreasonable risk of illness or injury.

Class III medical devices must go through 3 phases of clinical trials before they can be marketed to the public. These 3 phases are:

Phase I: Studies in a small number of people (20-80) to evaluate safety, side effects, proper dosage levels, and how the body handles the device. Depending on the device, prior to human trials, the FDA may demand lab and animal evidence of safety and efficacy.  Once this data is reviewed and approved, human trials may proceed.

Phase II: Studies in a larger group of people (100-300) to determine effectiveness and to further evaluate safety.

Phase III: Studies in an even larger group of people (1,000-3,000) to confirm effectiveness, monitor side effects, compare the device to similar devices already on the market, and collect information that will allow the medical device to be used safely.

Clinical trials are an essential part of bringing new medical devices to market. After a medical device has gone through all 3 phases of clinical trials and has been proven to be safe and effective, it can be submitted for FDA approval — and then eventually marketed to the public. 

What Makes Medical Device Clinical Trials Unique?

The clinical trial process for medical devices is similar to the process for drugs, but there are some important differences. First, medical devices are regulated by the FDA’s Center for Devices and Radiological Health (CDRH), while drugs are regulated by the FDA’s Center for Drug Evaluation and Research (CDER). 

Second, clinical trials for medical devices are generally smaller than those for drugs. This is because medical devices are used in a limited way and for a specific purpose, while drugs are taken by large numbers of people for many different reasons.

Finally, medical devices are usually tested in humans before they are approved for marketing, while drugs are often first tested in animals. This is because medical devices are usually less complex than drugs, so it is easier to assess their safety and effectiveness in humans.

Expert Guidance For Medical Device Clinical Trials

Pathway is a medical device company in San Diego, California. Our regulatory and quality assurance experts have decades of experience assisting in clinical trials. In fact, our comprehensive approach to the design, regulatory strategy, and manufacturing processes often shortens the FDA approval runway. Contact us today to get started. We also encourage you to learn more about our ISO standards for medical devices, and our contract medical manufacturing services.

The International Organization for Standardization, or ISO, is a globally recognized group of representatives. Headquartered in Geneva, Switzerland, they develop and publish standards for dozens of industries. This includes the medical and medical device ISO standards put into practice daily here at Pathway NPI. Both ISO 9001 and 13485 are quality management system standards that can be used by organizations to ensure that their products and services meet customer expectations. However, there are some key differences between the two standards.

We’ll take you through the history behind the ISO, how these quality standards originated, and how they can best be applied today. These standards apply to our daily work in design and engineering, regulatory, and manufacturing

The History of ISO Standards

ISO standards originated in the 1940s in an effort to standardize technical drawings across different industries. In response to the devastation of World War II, representatives from 25 countries gathered together to form what is now known as the ISO.

During the 1950s, ISO focused on creating standards for mechanical engineering. In the following decade, they shifted their attention to standardizing electronic components. It was during this time that some of the most well-known standards were published, including ISO 27001 and ISO 9001.

In 1987, ISO released the first iteration of ISO 13485. This was a quality management system standard specifically for medical device manufacturers. Since then, there have been several updates to both iso 9001 and iso 13485, with the most recent versions in place today.

While ISO 9001 is a generic quality management system standard that can be applied to businesses in any industry, ISO 13485 is specific to the medical device industry.

Organizations that want to demonstrate compliance with ISO 9001 can do so by implementing a quality management system and being audited by a third-party certification body. On the other hand, ISO 13485 compliance requires a quality management system specific to the medical device industry as well as third-party audits.

Get to Know ISO 9000

The ISO 9000 family of standards is all about quality management. In fact, it is the best-known quality management standard currently in place for businesses of all sizes.

The ISO 9000 family of standards is related to quality management systems and provides guidance on how to meet customer expectations. The most recent version, ISO 9001:2015, was published in September 2015. It outlines the requirements for a quality management system and can be used by any organization, regardless of size or industry.

ISO 9000 standards originated in 1987 and were created to help businesses improve their quality management systems. The family of standards includes ISO 9000, ISO 9001, and ISO 9004.

ISO 9000 is a generic standard that provides guidance on how to establish and operate a quality management system. It’s the foundation of the ISO 9001 standard and can be used by any organization, regardless of size or industry.

ISO 9001

ISO 9001 is a generic standard that can be used by any organization, regardless of its size or type of business. Any organization that wants to certify to ISO 9001 must follow the requirements in this standard.

In order to become certified to ISO 9001, an organization must go through a certification process conducted by an external body. This usually includes an audit of the organization’s quality management system to ensure that it meets all of the requirements laid out in the standard. Once certified, the organization will need to undergo periodic surveillance audits to maintain their certification status.

ISO 9004 is a guideline for organizations that want to exceed ISO 9001 requirements and continually improve their performance.

How to Demonstrate Compliance with ISO 9001

In order to demonstrate compliance with ISO 9001, organizations must implement a quality management system and be audited by a certification body. The certification process usually includes an assessment of the organization’s quality management system to ensure that it meets all of the requirements laid out in the standard. Once certified, the organization will need to undergo periodic surveillance audits to maintain their certification status.

Organizations that are already certified to ISO 9001 can transition to the 2015 version of the standard by following the guidance laid out in Annex SL of ISO 9001:2015.

Annex SL is a new framework for all ISO management system standards that provides a high-level structure and common terminology. This makes it easier for organizations to implement multiple ISO standards as well.

3 key takeaways:

– ISO 9001 is a quality management system standard that can be used by any organization, regardless of size or industry.

– Organizations can demonstrate compliance with ISO 9001 by implementing a quality management system and being audited by a certification body.

– The Annex SL framework provides a high-level structure and common terminology for all ISO management system standards. This makes it easier for organizations to implement multiple ISO standards.

Get to Know ISO 13485

ISO 13485, on the other hand, is specific to organizations that design and manufacture medical devices. It was first created in 1996 and has been updated several times since then, with the most recent version being published in 2016.

ISO 13485 is based on the ISO 9001 quality management system requirements and provides additional guidance specifically for the medical device industry.

In order to become certified to ISO 13485, organizations must implement a quality management system that meets all of the requirements laid out in the standard. They must also be audited by a certification body to ensure compliance. Once certified, they will need to undergo periodic surveillance audits to maintain their certification status.

How to Demonstrate Compliance with 13485

Compliance with ISO 13485 can be demonstrated by implementing a quality management system that meets all of the requirements laid out in the standard. Organizations must also be audited by a certification body to ensure compliance. Once certified, they will need to undergo periodic surveillance audits to maintain their certification status.

Key takeaways:

– ISO 13485 is a quality management system standard specifically for organizations that design and manufacture medical devices.

– Compliance with ISO 13485 can be demonstrated by implementing a quality management system and being audited by a certification body.

– The requirements of ISO 13485 are based on those of ISO 9001, with additional guidance specifically for the medical device industry.

Help With ISO Standard Compliance

In order to demonstrate compliance with either ISO 9001 or 13485, organizations must implement a quality management system. This system should be designed to meet the specific needs of the organization and its customers.

The quality management system must be regularly audited by a certification body to ensure compliance with the relevant standard. Once certified, the organization will need to undergo periodic surveillance audits to maintain their certification status.

The ISO standards for medical devices are significant — and can appear overwhelming. Here at Pathway NPI, a storied medical device company in San Diego, we have had great success at guiding companies through the steps as they develop their own products. We can help you too. If you have questions about 510(k) clearance vs. approval, we can answer those questions as well!

Pathway, a medical device contract manufacturing company you can trust.