<img src="https://ws.zoominfo.com/pixel/jVEeXSuAdJGwt07GfOBW" width="1" height="1" style="display: none;">
Get a Free Demo
2 min read

The Essential Requirements of Medical Devices QMS

By Peter Hargittay on Thu, Mar 17, 2022 @ 12:23 PM

A medical device quality management system (QMS) is a structured system of procedures and processes covering all aspects of design, manufacturing, supplier management, risk management, complaint handling, clinical data, storage, distribution, product labeling, and more.
The purpose of QMS is to improve the quality of the medical device and related services, constantly meet customer and regulatory requirements.

International Regulations Governing a Medical Device QMS
Nearly every major market requires the implementation and maintenance of a quality management system as a condition of product registration. Device manufacturers in Europe tend to follow the ISO 13485 standard, while US companies comply with the US FDA’s Quality System Regulation (QSR).

Key Benefits of  Medical Devices QMS

• Reduced market time for devices
• Deep root cause analysis in case of any error
• Adaptability in compliance with industry regulations
• Eradication of non-value added and waste activities
• Improved supplier relations and management


Medical Device QMS Requirements

The main medical device quality management requirements can be summarized as given in the following subsections:
• Document Control
• Training Management
• Audit Management
• CAPA Management

Document Control
Your medical device quality management system should include protocols and procedures for managing the many different documents that move within your organization, amongst sponsors, investors, and the regulatory agencies throughout the lifecycle of your product.
This entire process is referred to as document control.
Nowadays, many manufacturers have switched from traditional paper-based QMS systems to automated medical device quality management software solutions with robust document control capabilities. Such software automatically collects data, routes documents for review and approval processes of various documents, and stores them in a single storage location.

Training Management
International regulations/standards such as the FDA’s 21 CFR 820 and ISO 13485:2016 require you to only have specifically trained and skilled employees doing their job.
This means that all training procedures must be constantly evaluated, and all employee training records must be properly maintained.

Audit Management
Both the FDA’s 21 CFR 820 and ISO 13485:2016 require medical device manufacturers to establish a proper audit process and to conduct regular quality audits.
This is to ensure that the medical device quality management system as a whole is compliant.

CAPA Management
Under international regulatory rules such as the FDA’s 21 CFR 820 and the EU’s ISO 13485:2016, all manufacturers of medical devices must implement corrective actions and preventive actions (namely CAPAs) to rectify any instances of deviations or non-conformances that are likely to impact the quality of your product.

If you are interested in QMS for medical devices or you have any inquiries, you may contact Intellect's experts or request a free demo?

What's Next?

Now that you've learned about the essential requirements of Medical devices QMS, learn about the importance of implementing QMS in laboratories.

Peter Hargittay

Written by Peter Hargittay

Peter Hargittay is the Chief Marketing Officer (CMO) and VP of Corporate Development at Intellect. Peter is responsible for rebranding the company as Intellect from Interneer and for positioning the company for significant growth. Peter joined Intellect in 2013, and is responsible for corporate, product, and online marketing, business development through the Intellect partner channel, demand generation, sales enablement, and go-to-market strategies. Peter has more than 15 years of experience in building successful software and services businesses. Prior to Intellect, Peter served as the VP of Marketing and Sales Operations at Arise Virtual Solutions, and previously held executive marketing roles at Aegis, PeopleSupport, Intersil, and FileNet. Peter received both his BA in Economics and MBA from California State University, Fullerton.