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Regulatory Affairs

The medical device and welfare technology industries are subject to extensive rules and regulations. These regulations vary from country to country and are often wrought with excessive amounts of instructions, paperwork and forms.


The process can seem overwhelming, but it isn’t as complicated as it seems. A viable solution doesn’t need to be so different from your current systems — let RAQA show you how.

Frequently Asked QuestionsContact us
Planning and Scoping
Scope & Planning

Scope & Planning

We help you determine which regulations and standards apply to your product based on which markets you would like to enter or are already in.

From there we can determine the degree of assistance that you need. Our goal is to deliver the desired results while streamlining the process for you, so you can continue to successfully develop your products and business.

CE Approval Process (EU)

The CE Approval Process for Medical Devices can be a bumpy road. There are so many requirements to consider, documents to get in order, decisions to get right – not to mention finding a Notified Body with the time and expertise to conduct the required certification process. And that is just to have your product certified for use in one market (i.e. the EU). Other markets have other requirements and processes.

When scoping a product certification project, it is important to consider and plan for all of the necessary steps and requirements. This is the only way to ensure that everything is accounted for and create a realistic timeline for the project.

We have created this process chart to help you visualize and understand the the many facets of the certification process – download this free PDF for a closer look.

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Personalized advising


We are available to advise you on regulations and procedures, guiding you through the process from start to finish.

Don’t let high ambitions, good intentions and ingenuity become a hindrance — the regulatory process doesn’t need to be complicated. Together we will create a model that meets the level of assistance you require.

RAQA Advising
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Did you know?

Some products are covered by several different regulations and directives

This can make global registrations a little more complicated. You will need to monitor more sets of regulations, but it isn’t unmanageable. You just need to be aware and be organized.

Two categories of products which are regulated by more than one directive are height-adjustable hospital beds and any product with incorporated software.

We can answer your questions and help you navigate the system, finding the best solution for your organisation and your clients.
Process Implementation

Process Implementation

By defining and implementing procedures and processes, we can help build a solid foundation for your future work. We can create guideline documents and procedures that are easy to follow, so you minimize the amount of time and energy you spend on regulatory approvals.

This can be done in your existing quality management system (QMS), or alternatively, we can find and set-up one of the many useful and affordable online QMS resources.

Project Management

Project Management

If managing the regulatory process for your products is outside of your scope and current resources, we can help manage the entire process for you. We will ensure the process is completed professionally and efficiently.

We can assist in communication with Notified Bodies and other authorities regarding certification requirements and compile the information required by the authority.

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Did you know?

Regulations differ around the world

The process to register medical devices, the time required for processing, and the price of submissions vary around the world.

The primary regulating bodies are located in Europe (EU), USA, Canada, Brazil, Latin America and China. However, your products need to be registered in any market you wish to sell them in.

We can answer your questions, help you make an overview, and plan the required submissions. You are in good hands with RAQA.


Let us demystify the Regulatory Process for you.

We are ready to teach you how to navigate the rules and understand the procedures. When you are ready to try it on your own, we are only a phone call away with support, encouragement and good advice.



Frequently asked questions about Regulatory Affairs
What is Regulatory Affairs?

Regulatory Affairs is a profession within regulated industries, such as medical devices, pharmaceuticals or the financial sector.

Regulatory Affairs Professionals in the medical device industry are often responsible for:

  • Ensuring that current and coming products are in compliance with the relevant regulations
  • Compiling and submitting technical files to authorities or certification bodies
  • Collecting and evaluating scientific data for regulatory purposes and obligations
  • Collaborating with and advising management on strategic and technical information to support commercial and scientific activities within the company
  • Advising against poor or inappropriate decisions
  • Collaborating with external authorities, distributors and importers on product related submissions, documentation and post-marketing issues
  • Advising on regulatory intelligence and monitoring the changing regulatory climate to ensure any current or upcoming regulations are implemented in a company specific way

Due to the sheer demand for Regulatory Affairs Professionals, it is common that some or all of these tasks are outsourced. 

What purpose do Medical Device Regulations (MDR) serve?

Medical Device Regulations are always concerned with patient safety. This includes risk assesments and traceability, among other factors.

The Medical Device Regulation in the EU (2017/745) states that it:

"….aims to ensure the smooth functioning of the internal market as regards medical devices, taking as a base a high level of protection of health for patients and users, and taking into account the small- and medium-sized enterprises that are active in this sector. At the same time, this Regulation sets high standards of quality and safety for medical devices in order to meet common safety concerns as regards such products. Both objectives are being pursued simultaneously and are inseparably linked whilst one not being secondary to the other."

This means that each company must ensure that the risks associated with its products are minimized. In addition, the clinical benefits of the products must be demonstrated and documented.

Technical documentation must be contained in the company's Quality Management System (QMS).

What is involved in a CE Appoval Process for Medical Devices?

There are many requirements to consider, documents to get in order, and decisions to get right when applying for CE approval of medical devices in the EU.

We have created this process chart (PDF), to give you an overview of the many steps and the order in which you should approach them.

What are medical device "product risk categories"?

Medical devices are classified based on their risk to users. These categories are, from the lowest risk groups to the highest: Class I, Is, Ir, Im, Is, IIa, IIb, and III.

The intended use of your product and it potential risk to users determine into which category it falls. By looking at similar devices on the market and comparing your product to them can give you a good idea of the risk category for your product. Custom-made or altered devices can fall into any risk category.

Where can I learn more about MDR?

There are plenty of free webinars and sites where you can learn about Medical Device Regulations on the whole, or dive into specific topics, such as clinical evaluations.

Try Easy Medical Device's free mini course:

Or visit their extensive library of podcast interviews with subject matter experts on a wide range of topics:
Or on YouTube:

Greenlight Guru also offers many useful resources:

You can find a wide range of well priced digital courses – just search online.

Are there any good webinars about MDR?

There are some useful webinars created by Quality and Regulatory Professionals. They often help ‘set-the-scene’, teaching you the terms and purpose of  certain tasks.

We recommend that you watch:

Greenlight Guru

Are there guidance documents available for European MDR?

EU Guidance documents

There are plenty of guidance documents that can help you understand what is required for medical device regulation.  The EU’s Medical Device Coordination Group (MDCG) and the European Association of Medical Devices Notified Bodies Team (NB) both included endorsed guides and documents on a range of topics:



Are medical device regulations different around the world?

The short answer is "yes". The requirements, prices and timelines can vary for each product risk category in each certifying authority.

But don't be discouraged - we can help you make an overview and gather the required information.

Normally this regulation planning should be a part of your design and development process, but it is often first considered much later in the process.

Have a look at the list of the regulations in the primary markets here:

RAQA - Our Mission

Our Mission

To empower our clients by giving them the tools to navigate and comply with Medical Device Regulations in the EU and globally, so they can continue to successfully develop their products and businesses.

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