Quality Management Illustration

Medical Device Quality Management System (QMS)

by | Nov 24, 2021 | Medical Devices, QMS

A medical device quality management system (QMS) covers all aspects of your medical device’s life cycle. The purpose of QMS is to improve the quality of the medical device and related services, constantly meet customer and regulatory requirements.

It is, therefore, a regulated system of strategies and procedures for the design, manufacture, supplier management, complaints, storage and distribution, clinical data, labeling, etc., of your medical device.

Let us say that your company manufactures different types of medical devices, for example, stethoscopes (Class I), powered wheelchairs (Class II), and implantable pacemakers (Class III).

Each of these devices means different requirements for your quality management system (QMS) – based on the complexity of the devices.

In this article, we will be looking at the following:

What Is a Medical Quality Management System (QMS)?

A medical device quality management system is defined as a structured system that documents the procedures and processes implemented throughout the lifecycle of a medical device.

As a manufacturer of medical devices planning to sell your products in the international market, you are required to implement and maintain a quality management system compliant with international and national guidelines and regulations. This is referred to as a medical device quality management system.

Medical Device Quality Management System Elements

You should not confuse the medical device quality management system with an electronic quality management system (eQMS) or quality management software. The main difference between medical device QMS and eQMS is how each one manages documentation.

Quality Management System (QMS) can be managed using paper records and documents or you can use an eQMS software for this purpose.

What Regulations and Standards Are Governing Medical Device QMS?

Let us look at two major international markets, namely the US and Europe.

If you are marketing in the EU, you will have to follow the ISO 13485:2016 standard.

On the other hand, if you are marketing in the US, you will comply with the US FDA’s Quality System Regulations (QSR), which is also known by its US regulation number 21 CFR Part 820.

Thus, there are two major standards/regulations that you must be aware of:

  • ISO 13485:2016 Standard
  • FDA 21 CFR Part 820 Regulation

ISO 13485:2016 Standard

ISO 13485:2016 standard is defined as:

“ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that constantly meet customer and applicable regulatory requirements.”

Recommended Reading: ISO 13485:2016 Audit: Overview, Audit Types and Execution

FDA 21 CFR Part 820 Regulation

FDA 21 CFR Part 820 regulation is defined as:

“Current good manufacturing practice (cGMP) requirements are set forth in this quality system regulation. The requirements in this part govern the methods used in, and the facilities and controls used for, the design, manufacture, packaging, labeling, storage, installation, and servicing of all finished devices intended for human use.”

When Is a Quality Management System (QMS) Required for Medical Devices?

You may find it difficult to decide when you should start a quality management system for your medical device company. Also, the total time necessary to fully institute a QMS can range anywhere between 3 to 9 months. It is also crucial to look at the market you are targeting.

In the US, you must comply with the FDA 21 CFR Part 820 regulations when your medical device is registered for marketing. Furthermore, if your company produces medium to high-risk medical devices, you will have to go through the 510(K) process.

During the process of submitting the 510(K), you are expected to comply with 21 CFR Part 820. When you register your Class I or Class II medical devices, the FDA will enforce compliance through random inspections.

In most European counties, your company will have to obtain the CE Marking for your medical device before you can distribute it. Except when the medical device is a Class I non-sterile, non-measuring, and non-reusable surgical instrument, you will only be able to get the CE Marking if you meet the requirements of Article 10 and Annex IX of the new EU Medical Device Regulations (EU MDR). For most companies, these requirements are met through certification to ISO 13485:2016.

Recommended Reading: Medical Device Classification Guide (FDA & EU MDR)

When Should I Start Building a Medical Device QMS?

The timing for building a medical device QMS is crucial. As the manufacturer of medical devices, you would not want to start building a QMS right in the beginning, meaning when you are testing ideas, during the early prototype phase, etc.

Such an approach of getting a QMS ready will put unnecessary constraints on the initial development phase. You do not want to spend valuable time and resources on activities that are not essential during this phase.

Once you have done sufficient research and obtained enough knowledge about your product, the regulatory pathway, customer base, etc., you should start building a medical device QMS. This way, you will be better prepared for the first audits.

You should note that it is also not advisable to wait too long for building the medical device QMS since it takes time to build a suitable QMS.

Medical Device Product Lifecycle Illustration

How Long Does It Take to Fully Implement Medical Device QMS?

As the manufacturer of medical devices, you will understand that it typically takes around 3 to 9 months to fully establish a medical device QMS.

However, some medical device consultants may suggest that manufacturers of medical devices should begin preparations for a medical device QMS at least 18-24 months before commercialization and distribution. This will allow you to build, test, and improve your QMS through the various stages of the lifecycle of your new medical device design and development, validation testing, clinical trials, and the final market launch.

You may also find it advantageous to use a template package for the various procedures and protocols, quality manuals, etc. Such templates are readily available with the SimplerQMS QMS software solution. You should still keep in mind that these templates need to be adjusted to your particular needs!

Free Resource: Non-Conformance Report Template

What Are the Key Requirements for a Medical Device QMS?

We already know that there are two major standards/regulations – the ISO 13485:2016 standard and the FDA 21 CFR 820 regulation.

According to these, the main medical device quality management requirements can be summarized as given in the following subsections:

  • Document Control
  • Training Management
  • Audit Management
  • CAPA Management

Let’s look at each area, one by one.

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.

For example, your strategy department has updated a document that gives details of the changes to be made in the manufacturing process of a specific medical device. However, the updated document is not available to personnel in the production department. You need to take immediate steps to control all documents or destroy the obsolete ones as soon as possible.

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.

Crucially, QMS software such as SimplerQMS provides automatic version control. This means that only the current version of all documents is available in the system. Such a feature takes care of the problem highlighted in the example above.

An example of version control is demonstrated below.

Illustration of Document Version Control

Moreover, vendors such as SimplerQMS provide ready-to-use document control procedures.

Recommended Reading



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.

Let us revisit the example given above. You have made crucial changes to the manufacturing process of your medical device. But, the workers in the production line have not received the necessary training.

With quality training management software such as the SimplerQMS training management software module, the entire training process is automated right from the assignment of training tasks, distribution of training material, and the tracking of all training activities. All training procedures and forms related to training are also provided with the SimplerQMS solution.

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.

Unless you have properly audited all the required mandates for a medical device, you will not be sure about its safety and efficacy. Hence, it is essential to have proper audit management software in place.

The audit management software module by SimplerQMS facilitates the entire audit process – schedules activities, sets due dates, sends automatic notifications to the right personnel, and tracks the performance of all staff towards their due dates. Whenever an audit finding occurs, you will be able to easily link a response such as non-conformance, supplier corrective action request (SCAR), or corrective action and preventive action (CAPA).

Recommended Reading: Medical Device Audits: Overview, and Tips

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.

Additionally, all such actions must be documented carefully.

Key CAPA process steps are illustrated below.

CAPA Process Illustration

Let us say that you are manufacturing 16 gauge needles. But, an error has crept in and the needles are 15.9 gauge. This is a major non-conformance that needs to be documented and corrected.

With the SimplerQMS CAPA management software, you will streamline the entire CAPA process by automating data collection, routing, follow-ups, notifications, approvals, and escalation of overdue activities.

You can quickly initiate CAPA forms from deviations, non-conformances, audit findings, customer complaints, and much more. This should significantly reduce human error because the relevant data is automatically entered in the CAPA form, all without manual circulation of documents and chasing wet signatures.

Recommended Reading: What Is CAPA in the Medical Device Industry?

Frequently Asked Questions (FAQs) About Medical Device QMS

What Are the Two Main Quality Systems Adopted by Medical Device Manufacturers?

The two main quality systems that medical device manufacturers adopt are the US FDA’s 21 CFR 820 and the EU’s ISO 13485:2016.

What Is the ISO 13485:2016 Quality Management System?

The ISO 13485:2016 QMS specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that constantly meet customer and applicable regulatory requirements.

What Is the Difference Between ISO 9001 and ISO 13485:2016 QMS?

ISO 9001 is the international standard that provides specifications for a quality management system that can be used in any type of organization. On the other hand, the ISO 13485:2016 QMS is a complete quality management system exclusively for the manufacture of medical devices.

Will the US FDA Move to ISO 13485:2016?

The US FDA has made a formal announcement that they are replacing parts of the existing QSR (21 CFR 820) with ISO 13485:2016. This transition is still in the making and is currently in the rule stage.

Final Thoughts

The medical device quality management system is a regulatory requirement for manufacturers of medical devices. This quality management system will cover all aspects of your medical device’s lifecycle. It is a regulated system of strategies and procedures for designing, clinical data, manufacturing, storage and distribution, supplier management, complaints, labeling, etc, of your medical devices.

Medical device QMS software by SimplerQMS takes care of routine documentation activities allowing you to achieve efficiency with your QMS processes. If you are looking for an all-in-one QMS software solution to manage quality and complaince more effectively, we recommend scheduling a demo presentation to see SimplerQMS in action and talk to our experts.

eQMS Business Case Template

Illustration of eQMS Business Case Template