Mar 26, 2020 Robert Fenton

EU Medical Device Regulation: Is Your eQMS Helping or Hurting?

Adjusting to regulatory changes like the new EU Medical Device Regulation can be difficult at every level. But is your eQMS making it even harder than it has to be?

EU MDR requires organizations to emphasize patient safety protocols. Every part of your product lifecycle and the development process should be tracked, analyzed, and recorded to ensure compliance.

It’s essential that you have an eQMS that makes it simple to fulfill these requirements and doesn’t leave you wishing for additional features—such as inventory tracking and accounting.

For Operations and Manufacturing, the system works well. Accounting functions appear to have been an after-thought [and] there is no one, single place that tracks inventory transactions - it’s all in different files that must be accessed separately.” — Plex Manufacturing Cloud Review from G2.

Don’t make the mistake of choosing an eQMS that doesn’t give you all the features you need for EU MDR compliance—like the one mentioned above in the review from G2.

Here are a few ways to know if your eQMS is helping or hurting as you adjust to EU MDR.

EU Medical Device Regulation: Is Your eQMS Making it Easier or Harder?

The EU Medical Device Regulation is a legally binding regulation that is enforced throughout all EU member states. Failure to comply with these regulations may result in costly legal repercussions that could result in your company being forced to close its doors for good.

Don't let this happen to you.

Templates or modules?

Templates and modules give you greater flexibility to keep up with changes like we see in EU MDR. This won't be the last major regulatory change your company will face.

Can your eQMS keep up?

Qualio provides you with a set of commonly used templates, but you can also customize templates to meet the unique needs of your company. Customized templates include options for:

  • Naming the template
  • Assigning a descriptive prefix to the template, so it’s easily searchable in your Qualio library/workspace
  • Training availability and retraining requirements for future template updates
  • Document review dates
  • Publish dates, which allow you to save a template as a draft and auto-publish it on a future date
  • Sections with text areas and images that you want to be included in every document created from your custom template
  • Tags so you can organize your documents however you choose

Do you need to make changes to a template that has already been created and published? Qualio allows you to edit your templates as many times and as often as required to keep up with the changes in EU MDR regulations.

Sign up for your account with Qualio and start creating your own templates.

Is it comprehensive?

With supply chain scrutiny increasing, every step in the product lifecycle has to be documented well. Is end-to-end traceability possible with your eQMS?

If you fail to maintain meticulous records, your company could face excess costs and a loss of competitive advantage by increasing the time it takes to get your product to market.

An eQMS like Qualio that has been designed with the specific needs for life sciences companies will help you maintain compliance and keep up with the product development documentation despite the changes in regulations.

Features that are necessary for a medical device manufacturer include:

  • The ability to save documents as drafts and have them reviewed and approved before publishing
  • In-line commenting and editing for streamlined collaboration
  • Cloud-based access so your employees can access the information they need from anywhere
  • Access and permissions based on user roles
  • FDA CFR Part 11 compliant digital signatures
  • Traceability so you’re ready for FDA and EU MDR audits
  • A closed-loop system so you can respond quickly to any nonconformances you discover. With a closed-loop system, you don’t have to wait for a customer to complain or a CAPA event to alert you of these situations.

RELATED READING: 13 Bottom Line-Boosting Benefits of a Quality Management System

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Is it bloated?

Many of the larger eQMS providers have packed so much into their platforms over the years that they're redundant and hard to use. An eQMS that is inundated with too much data is more difficult for your computers to run efficiently.

Your company shouldn’t have to purchase supercomputers to run your eQMS software. You may even be opening your company up to nonconformance costs, such as external and internal failure costs. The FDA could also send you warning letters or charge your company with regulatory fines.

At this point, you’re starting to see that a bloated eQMS is bad for your company for several reasons. Choosing eQMS like Qualio can help you minimize these risks and keep you in compliance.

Qualio allows you to improve your quality processes and streamline conformance management. Our software provides the right balance of flexibility and structure that a company such as yours requires.

RELATED READING: 4 Reasons You Need an Agile QMS (And the Easiest Way to Get One)

12 Questions to Ask Before You Buy an eQMS

Is your current eQMS helping or hurting you? Don’t waste cash on a system that doesn’t work for your unique needs. Picking the wrong provider can be costly, and your employees won’t be happy with a system that is hard to work with.

Let us help you make an informed decision on what software provider to use. We are confident that Qualio is exactly what your business needs, but we want you to be just as confident as we are.

That’s why we created a free guide that provides you with all the knowledge you need to make the best choice for your unique circumstances. Download your copy of our free guide, 12 Questions to Ask Before You Buy an eQMS, to learn everything you need to know about choosing an eQMS provider. New call-to-action


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Published by Robert Fenton March 26, 2020