Since our establishment in 2013, QAdvis has continued to grow in an organic and controlled way. Based on client needs in a complex international regulatory context we have gradually and carefully expanded our team with the best people we could find, and continually invested in the team. In addition to QAdvis’ international MedTech consultancy, the companies QAdvis EAR and QAdvis UK Ltd. provides expert advice and legal representation in the EU and UK to medical device manufacturers all over the world. This way we strive to efficiently deliver services that are truly beneficial to our clients.
One key to deliver real customer value and be able to grow is that our international network has been extensive from day one. We are founding members of the European Association of Authorized Representatives and the UK Responsible Person Association. Furthermore, we actively participate in EU Commission MDCG working groups, several international standard committees, and other regulatory associations.
MDR is challenging for all types of devices, regardless of their classification. Two of the areas with increased focus in the new regulation are risk management and clinical evaluation. The regulation requires the two processes to be interdependent and regularly updated.
Clinical evaluation plays an important role in bringing a medical device to the market, since it collects and assesses clinical data to verify the safety and performance of the device. In this context, the clinical risks associated with the device and the clinical benefits are assessed, as well as the benefit-risk balance. Consequently, the results of the risk management applied to the device, need to be aligned and reflected in the clinical evaluation of the device.
If you want to learn more about how to link risk management and clinical evaluation, see the risk management course developed together with Swedish Medtech.
In our shop you will find MDR templates, checklist and declaration of conformity. You can also order MDR and IVDR books. Go to QAdvis Shop here.
If you have any questions about our newsletter, please feel free to contact Hermine Redl, Office Manager, by phone on +46 8 621 01 05 or email here.
What is your area of expertise within the Medical Device industry?
My expertise is broad, covering over 20 years of experience in product development, product risk management and quality assurance of complex medical devices, from startups to large multinational companies. An area which I am passionate about is product risk management, in which I have been working with both development of the international standard ISO 14971, as well as with practical application for different companies and wide range of products.
What is your best quality in your work as a consultant?
I can easily grasp new issues and find solutions tailored to customer needs, as well as ensure regulatory requirements are met.
If you can only pick ONE piece of advice to give to your client, based on your expertise, what would it be?
Risk management needs to be living through the entire product life-cycle. Make sure you update continuously the risk management file with input from production and post-production events.
Where do you find recovery in your everyday life? Eller “How do you recover after work?”
I like to work-out (biking, functional training) and spend time with my family and our dog and cats.
“I look forward to meeting you in our RM-course in November.”