About Us
Since 2018, RAQA ApS has provided services to manufacturers, distributors and importers of medical devices and health & welfare technology.
We help you plan and implement solutions that suit your company and fulfil your regulatory and quality needs. We are highly aware that this can be a very sensitive issue to people outside the company and we pride ourselves in keeping this privacy and use discretion at all times.
How we work
At RAQA, we have a broad base of experience and knowledge in the Regulatory Affairs area in the medical device field in Europe and many other countries. This means that we have a diversity and understanding to be able to adapt, adjust and implement the requirements based on how clients they run their businesses. We help our clients comply with the applicable regulations in a way that makes sense to them.
We have several, closely chosen, specialists in our team who work with Quality Assurance, Risk Management, Clinical Evaluations, as well as other specialized areas.
Based in Ringsted, Denmark, we work with Danish and European companies to help them navigate the MDR regulations and bring their product to market in the EU, as well as UK, USA and more.
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.
Our Vision
To support and empower innovative small and medium sized medical device companies and organisations, such as local councils and university hospitals, so they can continue to develop and improve devices and to support better health and treatment options for us all, now and in the future.
Meet Laura
Laura Rossing is the owner of RAQA and has experience consulting in the Medical Device industry. Her main fields of expertise are Regulatory Affairs and Quality Assurance Compliance, as well as communication with the Regulatory Authorities.
She is passionate about helping smaller companies navigate the complicated, bureaucratic regulatory process. Specializing in simplifying and streamlining processes, Laura establishes simple and effective quality assurance procedures that work in practice.
Laura participates in a range of different industrial organisation meetings and working groups, including Regulatory, AI and Sustainability.
She has a strong network of preferred partners with Medical Device expertise and involves them if there is a need and a match.
A strong beliver in strenghtening the local community, Laura supports other local businesses and organisations with sponsorships, often in partnership with other companies.
Get in Touch
We are here to help
Please send us a message and we will get back to you within 24 hours.