You have a great idea to improve patient’s treatment? You are an engineer that knows how to solve some of the current issues in the medical field?

Great! Go for it! Go and make the next medical device!

But first read this blog…

Next to the pure development of a medical device (the fun part), you need to take into consideration that there are legislations to be followed and rules to obey to. It’s better to know this at the start, rather than having to deal with that at a point where you have your finished device ready to bring to the market.

In this blog series, we will go step by step through the different aspects of setting up a QMS from scratch.

In the first article, we are going to focus on the scope of your QMS and the structure of your QMS.

In order to do so, you should ask yourself the following questions:

1. Which regulations and standards apply to my product and my organization?

This is the basis for everything you’ll have to do.

First of all you need to know which legislations apply to you. This will as well depend on the regions you are targeting. Do note that e.g. the definition of a medical device in Europe is not exactly the same as in the US.

Moreover, in some cases you might have a borderline product for which it is key to find out whether you have a medical device, a pharmaceutical, a cosmetic product, …

• In Europe, you can consult your national competent authority in case you need guidance deciding in which “category” your product would be placed. 

• In the US, you can obtain feedback from the FDA. 

The intended use and claims you make related to your device might make a big difference as we described in a previous article.

Let’s assume you know you are dealing with a medical device, you will have to define the applicable standards. This is not an easy task.

One tip is to go through the harmonized standards in Europe and/or the consensus standards in the US and verify which ones apply to you. It’s important to note that each country or region might have their particular standards that may or may not apply to your product or organization.

Next to these standards, there are many more and there is no central worldwide platform to search which ones would apply to you.

Other than the harmonized and consensus standards list, you should as well check the websites of the most common organizations that publish standards.

The main 3 would be:

• International Organization for Standardization (ISO) 

• International Electrotechnical Commission (IEC) 

• ASTM International 

Note that this is not a full list of standard organizations.

Why is this important to know as early as possible?

Some standards are company-wide and will affect your QMS. Others might require you to implement specific procedures and some will affect the way your device will look or function. 3 different levels, all important.

It's also important to estimate the resources needed to cope with all of these requirements as early as possible to avoid surprises down the road.

You will have to document the applicable standards and regulations in your Medical Device File.

1. What is the scope of my QMS?

In order to define the scope of your QMS, you need to know the different roles that your organization fulfills and which products are concerned. The 4 roles that are described in the Medical Device Regulation are Manufacturer, Authorized Representative, Importer and Distributor. Some Notified Bodies might ask you to be more specific and add e.g. Sales as well to the scope of your QMS.

The products do not need to be described in the smallest details, but mentioning “medical devices” will not be sufficient either. You should be aiming for a description that covers the different product groups in a clear way but still gives some freedom to add variants.

The scope of your QMS will define which sections of the quality management standard will apply to your organization and which ones can possibly be excluded.

The scope of your QMS will be documented in the Quality Manual of your QMS.

1. What will be the structure of my QMS?

First of all, you need to decide whether you’ll go for a paper-based QMS or an electronic QMS. As you are reading our blog, we hope that you’re at least considering using an electronic QMS, like MatrixReq.

An electronic QMS can help your organization to work in a more efficient and agile way. We posted an article about how a QMS can be agile before. 

The advantage of an electronic QMS is that it facilitates the traceability between regulatory requirements and your processes. It also significantly speeds up the review processes and allows centralized access to the QMS, which is important for international teams.

In the MatrixReq module we aim to have an agile QMS with an efficient review and publication process. MatrixReq provides a central platform where you can create, update and train people on processes and work instructions and perform process risk analyses.

All of these aspects will be highlighted in later posts of this series. 

If you are curious about MatrixReq, ask us for a demo.