How we work
Project Scoping
We can begin to scope your product and the necessary roles and responsibilities already at our start-up meeting. After the meeting, we develop a rationale which demonstrates your decision making process. How is your product categorized? Does it fit into a regulated product category? Is it covered by additional legislation and/or standards?
By answering these questions, we can get an idea of which resources are required. Our recommendations about how to proceed are based on the information that you provide about your company or institution.
Project Implementation
From there, we make a customized, realistic progress plan and help you implement the requirements and changes.
“We noticed that as competitive products became CE certified, our customers started to ask whether our product was also CE certified. Based on the function of our product, we didn’t require CE certification, but we needed to develop a rationale to demonstrate why this was the case. RAQA helped us establish this rationale.
The next product that we are developing will be a CE certified medical device and we are now better prepared to tackle it. We know which ressources we will require and how to approach the certification process.”
“We are situated in Denmark, which is one of the leading countries for the development of health and welfare technologies. By actively participating in forums and branch organisations, we are familiar with these companies and hear their concerns. But we are also in close contact with the policy decision makers, so we are better able to understand their approach.”
We hear your concerns
Understanding which regulations or standards are applicable for your product is a complicated process – and there always seems to be more regulations on the way.
At RAQA, we actively participate in a task force for the AI Regulation. This helps us gain insight into how to pragmatically implement these requirements for medical device companies in the EU. We also actively follow new developments in the Digital Health field and regulations related to health-based software and mobile apps in other countries.
You have processes in place, but they are hard to put into practice.
Many of the companies we work with already have verbal or written processes in place. However, they often experience difficulty juggling and incorporating their many daily tasks with these new procedures. Despite their good intentions, they fail to fully implement the processes. Company expansion and the introduction of additional work processes to comply with newly regulated areas make the task even more overwhelming.
RAQA can help with this process transition by documenting the initial process and setting up an online quality management system to capture the current practices and decision making. In that way, work is streamlined and future projects carry less risk from the outset.
We believe that everyone can contribute to compliance activities, given the right approach and understanding of the field – a little guidance and a few examples can go a long way!
The language and terms used in the regulations are not easy to understand.
We can help you understand the terms and thoughts behind the regulations. By using examples specific to your company’s approach to your products and customers, we make it relevant and understandable.
The consequences of specific actions (or inaction) are unclear.
In 99% of cases, we experience that employees pride themselves on making a safe and proper functioning devices or product for users.
We can teach you how to identify and talk about the potential risks of your product in a company-relevant way, so you understand the relevance and expectations of the regulatory process.
Experts and resources in the field are difficult to find.
The Health & Welfare Technology field is relatively new and growing fast, so regulations are being written and implemented on an ongoing basis. As it is an emerging field, there are few professionals who focus on this sub-set of medical devices, particularly for products focused on welfare, software and AI.
At RAQA, we work with classic Medical Device regulations, as well as the quickly growing health and welfare technology sub-industry. Many products, such as rehabilitation or training devices and daily living aids, are classified as medical devices and, therefore, regulated on par with traditional medical devices.
We are situated in Denmark, which is one of the leading countries for the development of health and welfare technologies. By actively participating in forums and branch organisations, we are familiar with these companies and hear their concerns. But we are also in close contact with the policy decision makers, so we are better able to understand their approach. This knowledge will benefit your company due to the knowledge, understanding and network that we share.
There are few who are experts in all of the newer regulations in the EU, but we strive to keep up-to-date and actively participate in courses and forums to learn about the new regulations. We aim to prepare companies and institutions for what is and what will be, so that they have a solid and robust foundation for the future.
“We are situated in Denmark, which is one of the leading countries for the development of health and welfare technologies. By actively participating in forums and branch organisations, we are familiar with these companies and hear their concerns. But we are also in close contact with the policy decision makers, so we are better able to understand their approach.”
Services we commonly provide
Project Management
- Scoping and product definition
- Preparing and/or updating technical files for the MDR
- Updating the entire technical file for the legal manufacturer
- Carrying out post-market activities
- Establishing contact with a Notified Body and helping the company through the certification process
Process Implementation
- Implementing and populating online or user defined Quality Management Systems to document processes
- Drafting and uploading Quality Agreement templates for suppliers, distributors and importers
- Establishing MDR related processes for communication with authorities and post-market activities
Advising
- Shortlisting applicable legislation or standards in other countries, such as UK and USA
- Finding suitable collaborators and representatives in other countries and drafting agreements with them
In addition to the services mentioned above, we provide a wide variety of services to help you determine, understand, and navigate the relevant medical device regulations.
Visit our Regulatory Affairs page to learn more.
FAQ
Frequently asked questions about the Health & Welfare Technology sector
How do I protect my company and its knowledge assets?
Secure all of your company's processes in an online Quality Management System (QMS). These systems provide a useful platform to implement and document your current practices. They also future-proof your company by giving a solid foundation on which to update and develop future documentation, as new requirements are introduced.
These platforms are often flexible, scalable and transferable. This last feature is important if the company is sold - a huge success factor for many companies in this field.
An online Quality Management System creates a strong foundation in the company and significantly reduces risk by helping guarantee that current company knowledge and processes are secured. The system is adaptable and provides a platform to document improvements and changes. Most medical device regulations can be built into these systems and reoccurring tasks can be automated.
Your product's technical information also needs to be well documented, particularly:
- decision making processes
- initial specifications
- intended use
- supplier information
- changes and improvements
A QMS provides the ideal platform to record and store all of this information.
How do I know if our product is a Medical Device?
This depends on its intended use and how it is categorized.
As an example, there are many welfare apps for rehabilitation and training that qualify as medical devices based on the way they function (data input and output). Some companies have products where just one component, e.g. a software module or physical component, are classified as a medical device, whereas other similar products might fall outside the category.
This is an ever evolving discussion and what seems applicable today may change tomorrow. The current trend it towards increased regulation, so more and more products will be required to meet regualtions in the future.
At RAQA, we recommend instate a scheduled regulatory monitoring process for your given product categories in all of your chosen markets.
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.
How do you determine the right documentation level for health and welfare technologies?
Health and welfare technologies can be classified under many different types of regulations, and many more are on the way. In addition to classifications, there are the relevant standards. Each classification and regulation require different types and levels of documentation. That is why it is essential to scope which regulations and legislation are relevant for your intended markets early in the development process, as the approval processes have different timelines and costs different amounts in each market.
Depending on which market(s) you are considering for your products, authorities often evaluate health and welfare products differently, depending on their intended purpose, where they are intended to be used (setting), and their intended effect.
What if we add new features to our welfare technologies when they are on the market?
This does not usually pose a problem and the required approvals are often swift, which is good for you and your users. However, check whether the updates are categorized as major or minor, as this could potentially warrant a new UDI or classification.
Under the MDR, the definition of major or minor changes are described in the following guidances:
- MDCG 2020-3: Guidance on significant changes regarding the transitional provision under Article 120 of the MDR with regard to devices covered by certificates according to MDD or AIMDD
- MDCG 2018-1 Rev.4 Guidance on BASIC UDI-DI and changes to UDI-DI
- MDCG 2018-5 UDI Assignment to Medical Device Software
Get in Touch
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