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Medical Device Development 101

5 Steps for Setting up a QMS for Medical Devices

The EU Medical Device Regulation came into effect on 26 May 2021 and it requires that all manufacturers, even those whose products have a valid CE certificate under the old Medical Device Directive, have a compliant quality management system (QMS). So, we thought it was a good opportunity to share our experience for setting up a QMS for medical devices.

5 Steps for Setting up a QMS for Medical Devices

Remember, the QMS should work for you and not the other way around. How? Find out!

What is a Quality Management System?

The concept of quality in business has many definitions but at the core is the “production” of a physical item or a service to meet or exceed safety and reliability requirements.

A quality management system (QMS) for medical devices is then a structured system of policies, processes and procedures for managing and overseeing the different phases in the lifecycle of a medical device, such as design, engineering, manufacturing, risk management, technical quality assurance, supplier management, handling of customer feedback, clinical data gathering, product marking, storage, and distribution.

Can I get an off-the-shelf QMS?

There are tools that will generate an “off-the-shelf QMS”. However, you must still customise the resulting QMS to your exact situation. This means that you will have to include any processes that you already follow, and you must also incorporate processes for other compliance requirements, e.g. risk management and technical standards. The goal of the QMS is to not just to say you have a QMS. The goal of a QMS is to simplify product compliance. Therefore, the QMS must take into account everything that you need to do in order to ensure product compliance.

The best solution for a QMS is to build the actual system, either by yourself or with the help of an expert who can steer you in the right direction. This way you get exactly what you need.


5 Steps for Setting a QMS for Your Medical Device

The overall process for setting up a QMS for medical devices is quite straight-forward.

We’ve separated it into five main steps (Figure 1) with the goal being that you get a certified QMS:

  • Decision and planning
  • Analysis and documentation
  • Implementation, control and measurement
  • Internal Audit
  • Informal External Audit and Certification



Figure 1: Main steps to setting up a QMS

Step 1: Decision & Planning

Setting up and maintaining a QMS requires time and effort, which means extra cost for the bottom line. So, a fundamental requirement is buy-in from management. If the top-brass of a company do not understand the need for a QMS and don’t fully support QMS activities, then quality activities will be more of a challenge.

It is easier to setup and maintain a QMS if you have a team. It doesn’t have to be large, but it should have some permanent team members who are responsible for quality and others who are brought in at specific stages, e.g. during internal audits. The team will be responsible for setting up and maintaining the QMS. Sometimes, specific legislation requires the appointment of a person for a specific quality-related role, e.g. the EU MDR requires a “person responsible for regulatory compliance” (PRRC). The PRRC in a company should be on the quality team. The members of the QA team will also help educate others in the company about the QMS and its processes and procedures. Some members of the QA team should have experience in quality assurance, and if some skills are lacking then you should ensure that your team receives the correct training or that you bring in external consultants who can advise you.

Create a detailed plan for setting up the QMS, taking into account resources, and effort. Also, perform a complexity assessment for your products and look at how this impacts on your QMS.

Step 2: Analysis & Documentation

Start your analysis by briefly documenting what you already do as a way of capturing your baseline processes. The key here is to keep it simple!

What a QMS complies with is ultimately determined by which regulatory requirements and standards the medical device needs to comply with. These can come from regional directives or national regulations, e.g. EU, as well as any technical standards. So, at this point, look at what regulations and standards apply to your product for your target market. This phase can take some time, but it is the heart of a QMS. Read the article on Medical Device Compliance for a complete overview of all that you need to consider to ensure compliance.


Step 3: Implementation, Control & Measurement

Now you are ready to start constructing your QMS. Using the requirements you have identified, define processes that comply with the requirements and create “standard operating procedures” (SOPs). These define what needs to be done, but it should not describe how. The “how” is defined in works instructions (WIs) where you would specify the exact steps to perform, including tools required, in order to execute the procedure defined in the SOP

Once you’ve got your SOPs and WIs, you have to spread the word to the people who actually need to follow the procedures.

After the procedures have been followed, get feedback from the people who use them. The processes should support your people to make sure that the device is compliant, but they should work with your people. Examine the feedback and use it to adjust your processes.


Step 4: Internal Audit

A few members of your quality team should be designated as “internal auditors”. They have the task of looking at your QMS as it would be examined during the certification process. For any deviations that emerge, analyze, define improvements, implement improvement and repeat.

Step 5: Informal External Audit & Certification

If you are creating your QMS to be compliant with a specific regulation or standard, then you will want to get it certified by an accredited independent auditor or certification house to confirm compliance. Certification is not necessary but it will simplify the process when you are ready to get your medical device certified.

However, before you embark on the actual certification, get an independent external consultant to do an informal audit of your system. This is not necessary, but it is an opportunity for an expert to identify any deviations which you can resolve.

Once you have resolved any deviations that emerged from the informal audit, you are ready to apply for your QMS to be certified.

After Certification

Of course, even after your QMS has been certified, you should still regularly monitor how the processes are working and make improvements. Remember, the QMS should work for you and not the other way around.

Do You Need Help with Setting up a QMS for Your Medical Device?

We are here for you! Please contact us at Our team of experts would be happy to help you.

ArrowFast Team

ArrowFast Team

ArrowFast Team - A group of Medical Device Engineering Specialists

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