By using this site, you agree to the Privacy Policy and Terms of Use.
Accept
Health Works CollectiveHealth Works CollectiveHealth Works Collective
  • Health
    • Mental Health
    Health
    Healthcare organizations are operating on slimmer profit margins than ever. One report in August showed that they are even lower than the beginning of the…
    Show More
    Top News
    physical health
    5 Ways Playing Games Can Improve Neural and Physical Health
    September 9, 2022
    Reasons For Hair Loss and Its Treatment
    Reasons For Hair Loss and Its Treatment
    February 16, 2022
    healthcare organization
    5 Actionable Strategies For Healthcare Organizations
    August 15, 2022
    Latest News
    Grounded Healing: A Natural Ally for Sustainable Healthcare Systems
    May 16, 2025
    Learn how to Renew your Medical Card in West Virginia
    May 16, 2025
    Choosing the Right Supplement Manufacturer for Your Brand
    May 1, 2025
    Engineering Temporary Hospitals for Extreme Weather
    April 24, 2025
  • Policy and Law
    • Global Healthcare
    • Medical Ethics
    Policy and Law
    Get the latest updates about Insurance policies and Laws in the Healthcare industry for different geographical locations.
    Show More
    Top News
    email marketing in healthcare
    Harnessing the Power of Email Marketing in Healthcare
    October 26, 2023
    healthcare claims
    The Role of Communication in Resolving Complex Workers’ Compensation Claims in Healthcare Settings
    September 22, 2024
    Wounds and Wisdom: What Motorcycle Accidents Teach Us About Health and Healing
    Wounds and Wisdom: What Motorcycle Accidents Teach Us About Health and Healing
    February 12, 2025
    Latest News
    Building Smarter Care Teams: Aligning Roles, Structure, and Clinical Expertise
    May 18, 2025
    The Critical Role of Healthcare in Personal Injury Recovery: A Comprehensive Guide for Victims
    May 14, 2025
    The Backbone of Successful Trials: Clinical Data Management
    April 28, 2025
    Advancing Your Healthcare Career through Education and Specialization
    April 16, 2025
  • Medical Innovations
  • News
  • Wellness
  • Tech
Search
© 2023 HealthWorks Collective. All Rights Reserved.
Reading: 4 Reasons Why Medical Device Compliance Matters
Share
Notification Show More
Font ResizerAa
Health Works CollectiveHealth Works Collective
Font ResizerAa
Search
Follow US
  • About
  • Contact
  • Privacy
© 2023 HealthWorks Collective. All Rights Reserved.
Health Works Collective > eHealth > 4 Reasons Why Medical Device Compliance Matters
eHealthPolicy & Law

4 Reasons Why Medical Device Compliance Matters

beatrix.potter
Last updated: May 22, 2020 5:20 pm
beatrix.potter
Share
8 Min Read
SHARE

It doesn’t take much to know that medical devices – through their revolutionary technological advances – save lives; so, when you create a device for medical professionals to use, you’ll be helping saving lives. But before you can get your device out to the market, you’ll need to know medical device compliance.

Every medical device manufacturer has to comply with regulations, or else the manufacturer will risk their future, and their device won’t see the light of day. Of course, these guidelines and regulations vary from country to country, but the benefits and necessity of these laws are the same throughout.

Whether you’re buying and using medical devices of any kind, designing and producing your own, or you simply have an interest in making sure devices in your life or workplace are giving you the best results, here are four reasons why having medical device compliance matters.

More Read

Social Media – Shoulder Surgery Decision Making
85 Year Old Surgeon Gets 3 Years Probation in Death of Patient Under Going Cosmetic Surgery
How Health Innovators Can Foster Patient Empowerment
Use It or Lose It: The Price of Inactivity
How Social Media is “Consumerizing” Healthcare

Risk Prevention

Risk prevention is one of the major purposes of regulatory compliance. This allows medical device industries to identify, mitigate, and eliminate the risks at all stages. Industries can learn, as well as educate their workforce, on how to spot the risks and deal with them by following the guidelines that regulatory agencies have.

The processes suggested by the regulatory agencies need to be readily available to the manufacturer, so that they don’t miss a beat in the compliance process.

It’s obvious that if a device isn’t up to scratch and doesn’t meet compliance, then you could be left with a product that’s not accurate and doesn’t given the best results or the desired outcome. For example, if you have a ventilator that’s supposed to output up to 200ml of medicine into an oxygen supply, but it doesn’t meet compliance in terms of accuracy and only gives 100ml, people’s lives could be on the line.

Gain Customer/Investor Trust

Consumers (even stakeholders, employees, and other investors) want a brand that they can trust; but they won’t be sold into using the product, unless they know it has complied with regulatory requirements.

Medical device compliance puts that safeguard and guarantee that people can depend on, which leads to the much-needed stamp of approval. When you have a large brand, this is a loyalty and trust that you can’t compare too. As a small business or producer, it’s imperative that you take time to build up your brand.

If you work as a company that nobody else can trust, you’re not going to be very successful as a business. Achieving the set requirements of compliance means that you’re already meeting the standard that everybody is looking for, and it means people are far more likely to use your products.

Get Regulatory Approval

But how can a medical device prove that it’s safe for consumer, corporate, or medical use?

For starters, the medical device industry is heavily regulated by regulatory bodies like the FDA. These regulatory bodies have compliance regulations in place to make sure medical devices are safe to use, and they promote quality manufacturing. In their launch of the Case for Quality program in 2011, the FDA wanted manufacturers (including medical device manufacturers) to produce high-quality products.

In most cases, you’ll need to comply with not only the FDA (which is based in the US), but also the ISO (which is for international use). No matter what, your device will need that stamp of approval – no exceptions.

As we said in the introduction, this can vary from country to country, so you need to make sure you’re looking for the most up-to-date information on your official government website, or even using a third-party consultant or advisor firm that can help give you the information and legal requirements that’s relevant to you and your products.

Better Preparation For Audits

No one knows when they will be audited. In fact, the FDA wants manufacturers, especially those who make medical devices, to have quality audits every 12 months or less. So, your best bet is to be ready for any medical device audit, by meeting compliance regulations and having a well-documented traceability matrix.

But what happens if you don’t pass an audit?

“Penalties tend to be swift, if you don’t pass an audit,” Rose adds. “First, you’ll need to fill out a 483 form for the FDA, responding to the failed audit from the regulatory body. Then, not only will you be forced to pay fines, but this will ultimately damage your reputation as a manufacturer.”

The more prepared and compliant you are right off the bat, the less you’ll have to worry about audits because you know you’re already operating within the boundaries of the law, and an audit isn’t going to shock you with any unforeseen surprises.

So, How Do You Achieve Medical Device Compliance?

Now that you know why medical device compliance matters in this industry, how do you actually comply with regulations?

First, you’ll need to be able to trace everything from requirements to test cases. Regulatory agencies are dead-set in finding out whether or not you’re following their guidelines. In fact, these agencies want you to follow their rules to a tee.

That’s where the traceability matrix comes in – this helps you prove to regulatory agencies that you’re complying with their rules. To create a traceability matrix, you can use Microsoft Excel to record your compliance, rather than use word processing programs like Word to write down everything.

Or, you can start today. Start detecting errors early and testing your devices every so often, so that not you save on costs, but you would also be certain that your product is meeting the requirements during the development stage.

Conclusion

Regulatory agencies like the FDA, the EMA, etc. are in place to make sure that the pharmaceutical, medical device and healthcare industries deliver the best products to consumers. Yes, compliance may seem like hard and or too much work, in at the end of the day, people rely on products, especially if they see them as lifesaving.

Now, this guarantee of safety will not be achieved, unless medical device manufacturers make products that adhere to the regulatory compliance requirements set out by said regulatory agencies.

TAGGED:medical devicemedical device compliancemedical devices
Share This Article
Facebook Copy Link Print
Share
By beatrix.potter
Bea Potter is a marketing specialist and a writer for UK Top Writers and State Of Writing, with more than 6 years helping businesses enhance their online presence. She understands the language of business and knows the importance of delivering results to clients. Also, she is a blogger at Best assignment writing services reviews website.

Stay Connected

1.5kFollowersLike
4.5kFollowersFollow
2.8kFollowersPin
136kSubscribersSubscribe

Latest News

Clinical Expertise
Building Smarter Care Teams: Aligning Roles, Structure, and Clinical Expertise
Health care
May 18, 2025
Grounded Healing: A Natural Ally for Sustainable Healthcare Systems
Grounded Healing: A Natural Ally for Sustainable Healthcare Systems
Health
May 15, 2025
Learn how to Renew your Medical Card in West Virginia
Learn how to Renew your Medical Card in West Virginia
Health
May 15, 2025
Dr. Klaus Rentrop Shares Acute Myocardial Infarction heart treatment
Dr. Klaus Rentrop Shares Acute Myocardial Infarction
Cardiology
May 13, 2025

You Might also Like

Can Long-Term Physician-Patient Relationships Be Bad For Your Health?

April 23, 2012

The Day After: Health Care Reform after NFIB v Sebelius

June 23, 2012
claim a disability benefit
Health careUncategorized

Are You Eligible To Claim A Disability Benefit? Why To Talk To A Lawyer

October 1, 2020
connectivity in health
DiagnosticseHealthMedical DevicesRemote DiagnosticsTechnology

Connectivity Workflows

October 30, 2013
Subscribe
Subscribe to our newsletter to get our newest articles instantly!
Follow US
© 2008-2025 HealthWorks Collective. All Rights Reserved.
  • About
  • Contact
  • Privacy
Welcome Back!

Sign in to your account

Username or Email Address
Password

Lost your password?