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Why Medical Device Compliance Is So Important for Business Owners

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The sooner a medical device can be on the market, the sooner it may help individuals. But to do that, you need to have your medical device be officially compliant.

The success of your medical device relies on achieving medical device compliance. This is why medical device compliance is so important.

Medical Device Compliance Ensures Safety For Patients

Every patient receiving treatment via a medical device is under the assumption that the device is safe. These devices are designed to save lives and improve health. Achieving compliance means that the device is very safe. The ultimate goal of every medical device is to improve patient’s lives, not make them worse.

Regulatory Bodies Are In Charge of Approving Compliance

One of the most heavily regulated industries is the medical device industry. Regulatory agencies, such as the FDA have medical device regulations in place to ensure that medical devices are safe to use. The FDA also emphasizes the importance of creating high-quality devices. 

Producing high-quality devices is in everyone’s interest, and this is why the FDA launched a program to help manufacturers achieve high-quality results. Getting stamps of approval is a necessary step in having your device make its impact around the world.

For U.S. manufacturers, and global manufacturers wanting to have their device used in the U.S., you are required to have compliance from the FDA. Medical devices designed for international use require ISO compliance. But in many cases, both compliances might be required.

Without medical device approval, you may face severe penalties. And the longer you stay non-compliant, the longer your device will not reach any type of market.

Medical Device Audits Can Happen At Any Time

Just like any governing agency, an audit can happen at a moment’s notice. As per the FDA’s recommendation, quality audits may happen at least once a year. This means you should always be prepared for one.

For medical device companies that have already met compliance regulations, there should be no worry about an audit. But if you fail an audit, you may experience incredibly high penalties.

What Are the Penalties?

First thing, you will need to respond to the governing regulatory agency, which may require you to fill out a 483 form (in this case if it were the FDA). You will then be required to fix whatever issue they found in the audit, which may also result in a fine. There are also many other negative repercussions associated with a failed audit, which could either result in a recall of a device and damage to your business’s reputation. 

How Can You Achieve Medical Device Compliance?

While gaining compliance may seem simple, there are unique and complex steps that can be difficult to traverse. The most efficient way of achieving compliance would be to work with a medical device consulting firm. An experienced and professional agency that specializes in medical device compliance will ensure every step of the regulatory submissions and testing process is abided. This prevents any hiccups in achieving either FDA or global compliance.

About the author


Marc H

Marc H is a marketing representative based in Minnesota who works as a small business consultant. Marc specializes in web marketing and SEO strategies.