Welcome Irene Sebastianutto and Patricia Marmol!

We are very glad to welcome two new consultants to our team. Irene Sebastianutto PhD, native Italian, is based in our Lund office and Patricia Marmol PhD, native Spanish, is based in Stockholm. With these new fantastic colleagues, we are strengthening our clinical team and further increasing our international platform. Read more about our clinical services here.

Patricia is very experienced in molecular biology and biochemistry, both in vivo and in vitro. She has a background in academic research, which includes almost ten years of experience as a researcher at Karolinska Institute in type 2 diabetes, metabolism and biomarker and metabolite analysis. Her qualification also includes postgraduate education in regulatory affairs and clinical trials. Patricia uses a rational and fact-based approach and seeks for quality in her commitments.

Irene has her academic merits in biomedicine and neuroscience from Lund University and has over ten years of experience in preclinical research within the field of neurodegenerative disorders. During the past year, she has focused on medical devices and in particular clinical evaluation reports. Irene has a broad interest for life sciences, an analytical mind, and a genuine passion for innovation.

QAdvis congratulate EXINI Diagnostics AB for achieving their MDR-certificate

QAdvis want to congratulate one of our customers, EXINI Diagnostics AB, for achieving their MDR-certificate with help from our highly skilled consultants.
The transfer to MDR and IVDR is getting closer to certification for many medical device manufacturers,
We are proud that we can be part of that journey for several customers, guiding as well as providing hands-on work during both implementation and certification process.

“QAdvis has been invaluable to EXINI in achieving this significant milestone. We are proud to be certified for MDR and look forward to enhancing the care of cancer patients with digital AI-solutions”
Dr. Aseem Anand. Vice President EXINI Diagnostics AB.


United Kingdom Responsible Person

We are delighted to offer our professional services and to support you with successful post-Brexit clearance in the United Kingdom.

In relation to the ongoing Brexit process, the regulatory landscape for medical devices and in-vitro diagnostic devices in the UK is significantly changing.

Current guidance from Medicines and Healthcare products Regulatory Agency (MHRA) requires non-United Kingdom based manufacturers to designate a United Kingdom Responsible Person (UKRP) from Jan 1st 2021. The UKRP is essentially an authorized representative established in the United Kingdom with the role to act as the manufacturer’s representative in the communication with the MHRA. This is required for both new medical devices or to continue to place current medical devices on the UK market.

Read more here …