+45 40 12 99 69 [email protected]

Welcome to RAQA

Regulations for medical devices and health and welfare technologies are difficult to navigate and documentation must be kept up-to-date. You don’t want to risk your investment or be denied market access by not having the correct documentation in place.


Finding a pragmatic consultant who can advise on all classes of device can be difficult, but that is exactly what we offer. Our consultants are ready to listen to your concerns and issues – and we help you solve them in a way that best fits your company’s practices and budget.


We are flexible and offer customer orientated solutions. Whether you want us to complete the work for you or create procedures and teach you how to complete the processes yourself, we are ready to help.

Benefits for youAbout RAQA

Our Services

Let us help you scope a plan to solve your company’s challenges. We use different methods and approaches and are able to tailor-make a solution for your company which reflects your practices and approach.

Often we start by simply answering your questions. Then we focus on the long term goals, including compliance of the necessary requirements.

We help you understand, navigate and implement the necessary regulations and standards in the way best suited for your company, so that you can focus on what is important to you.

RAQA - Regulatory Affairs

Regulatory Affairs

  • Determine which regulations and standards apply
  • Detect problems and address issues
  • Advise on appropriate procedures and frameworks
  • Draft and compile technical files
  • Create a strategic management plan for files and regulatory systems
  • Ensure ongoing project development is not disrupted
RAQA - Quality Assurance

Quality Assurance

  • Implement a Quality Management System (QMS) which supports current market requirements
  • Determine and implement appropriate QA practices
  • Draft and implement QA-related processes
  • Train work groups on Quality Management System
  •  Ensure ongoing projects are not disrupted

Certification process

The registration and certification process for medical devices can be very extensive. There are many parts that are in the manufacturer’s control (gold boxes), while other parts rely on a notary body or regulatory authority (green boxes).

RAQA can help you navigate and streamline this process, so you save time and avoid unnecessary work and stress.


Intended use

Target audience

Risk to patient

Desired sales market(s)

1-2 meetings


Conformity assessment route

Certification procedure

Registration process

Need for distributors / importers / local representatives

1-2 meetings per country / region


2-3 days

CREATE Technical File

4-6 months


2-3 months

INITIATE Certification Process

~6 months

Certification Process

12-18 months


Product can be distributed and sold in the approved market

Post Market Activities

Benefits of working with RAQA

Personalized advising

Advice specific to your company’s products, practices and approaches

Navigate the system

Learn to navigate the system and understand the process

Feel empowered

Feel empowered to continue the work on your own, or with the level of support you desire

Detect oversights

Detect expensive and time consuming errors and oversights

Implement processes

Implementation of suitable systems, processes and procedural frameworks

Protect investment

Protect your investment


Protect your company by understanding and following the relevant regulations for your industry. We can help you select and navigate the necessary regulations, define the necessary procedures, and create a practical framework.

We assist Manufacturers – Distributors – Importers from the following sectors:

Medical device sector

Medical Devices

Products or equipment intended for a medical purpose. These can range from simple tongue depressors to complex artificial organs, or even products like medical journal software.

Welfare technology sector

Health and Welfare Technology

A sub-category of medical devices designed to improve the life and quality-of-care for patients – often by increasing security, activity, participation or independence.

Municipalities and hospital sector

Local Councils and Hospitals

Did you know that you become a 'medical device manufacturer' if you alter, adapt or use medical devices in a way other than intended?

See more details in the box below.

RAQA - Did you know? icon

Did you know?

Changing and altering devices can be dangerous
If you update or change a medical device with a custom attachment or alternative part than specified, you are then defined as a medical device manufacturer. It will need to be documented in your Quality Management System and assessed for potential impacts and risks.

The change can be as simple as using a different mattress on a hospital bed or adding a headrest to a wheelchair, but can have important consequences with regards to responsibility and even more daunting, liability.

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


Customer logo Curapax

“I choose to work with Laura because she is trustworthy. She uses the right approach and offers competent, well thought-out solutions and insights into the future that you can trust.

It frees up some time for me, and it gives me a sense of security when I work with RAQA. I am sure that everything that is being done is in order.”

Søren Badstue

Owner, Microwarm ApS

Customer logo Innoventa Medica

“We have been working with RAQA since 2021, and Laura has been a major contributor in helping us obtain MDR approval of our Class IIb implant products.

Laura has been helping us both with regards to establishment of the technical files and certification of our QMS system to meet the MDR standard. She has a good relationship with our customers and is trusted to participate in meetings with them and staff from our company.

Laura is a trustworthy person who seeks to simplify issues, and she takes a pragmatic view when needed.”

Niels Erik Holm

CEO, Innoventa Medica

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Get in Touch

We are here to help

Please send us a message and we will get back to you within 24 hours.