How we work
RAQA helps small and medium sized medical device companies achieve regulatory compliance for their products – compliance that is necessary for products to be sold on the market. For some companies, we create the entire technical documentation package, while for others we assist with specific tasks, like setting up processes, post-marketing activities in the Quality Management System or writing reports.
Our specialty is the regulatory process for Class I and Class IIa and IIb products.
We create value for companies by giving them a strategic and planned process of how to approach and secure market access in their chosen markets.
RAQA can also act as the ‘Person Responsible for Regulatory Compliance’, in accordance with Article 15.
“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. She is a trustworthy person who seeks to simplify issues, and she takes a pragmatic view when needed.”
“We are true believers in that anyone can do regulatory work, given the right approach and understanding of the field
– a little guidance and a few examples can go a long way!”
We hear your concerns
Regulatory processes are difficult to understand and thereby difficult to implement.
Many of the companies we work with are small and this means that there can be very diverse educational and work experience profiles behind the different tasks.
We are true believers that anyone can do regulatory work, 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.
Resources in the regulatory field are difficult to come by.
It is difficult to know if you have the right person or skill set in-house or in a consultant.
We help companies help themselves by guiding them through the requirements, based on a prioritized list of what they feel they need. We offer input and can help with operational tasks to move the process forward. This is, in many ways, part of our one-on-one training of employees.
By sharing information and creating company-specific procedures, we help build your employees’ skillsets and confidence.
“Getting help to make the first steps often makes it easier to establish a methodology and healthy approach so that you also can plan your Regulatory tasks in and around the other tasks at hand”
Services we commonly provide
Project Management
- Transferring and updating technical files from MDD to MDR format
- Establishing a collaboration with contract manufacturers and ensuring transmission of the technical file
- Updating and compiling the entire technical file for the legal manufacturer
- Planning and executing maintenance processes
- Establishing contact with a Notified Body and helping the company through the certification process
Process Implementation
- Establishing MDR related processes for communication with authorities and post market activities
- Drafting and uploading Quality Agreement templates for suppliers, distributors and importers
- Establishing the metadata structure in new QMS systems
Advising
- Finding suitable collaborators in other countries, such as UK or USA
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 Medical Device sector
What are Medical Devices?
Medical devices are products used for health reasons. The common theme is that they all serve a therapeutic purpose. Examples range from everyday items like band-aids and syringes to daily living aids like wheelchairs and products like implants and MRI scanners. They can even encompass periphery products like health-based apps, software and medical journaling systems.
What purpose do Medical Device Regulations (MDR) serve?
The purpose of Medical Device regulations is always a question of of patient safety. This includes risk assesments and traceability, among other factors.
The Medical Device Regulations 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 the company must ensure that the risks associated with their products are minimized. In addition, the clinical benefits of the products must be demonstrated and documented. Technical documentation must be contained in a Quality Management System (QMS) within the company.
Where can I learn more about MDR?
There are plenty of great free webinars and sites where you can learn about Medical Device Regulations as a whole, or dive into specific topics, such as clinical evaluations.
Try Easy Device Devices free mini course:
https://easymedicaldevice.com/resource/resource-medical-device-regulation/mini-course-mdr/
They also have a great library of expert interviews podcasts on a wide range of topics:
https://podcast.easymedicaldevice.com/ Or on YouTube:
https://www.youtube.com/c/EasyMedicalDevice
Greenlight Guru also has plenty of inspiring materials:
https://www.greenlight.guru/medical-device-resources/ebooks-and-guides
There is also a huge 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
https://www.greenlight.guru/medical-device-resources/webinars
Are there guidance documents available for European MDR?
EU Guidance documents
There are plenty of guidance documents that can show you and 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:
https://easymedicaldevice.com/resource/resource-medical-device-regulation/
Get in Touch
We are here to help
Please send us a message and we will get back to you within 24 hours.