QAdvis is a solution-oriented trusted service provider for the medical device and in vitro diagnostic device sector. To enable and maintain global market access, we can with high level of knowhow and expertise within quality management and regulatory affairs support your company to be in compliance with applicable regulations and requirements. QAdvis was founded in 2013 and is based in Sweden. We are certified according to ISO 13485:2016.
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 […]
Accelerating Innovation & Streamlining Compliance for Medical Devices Engineering
QAdvis is pleased to participate in an exclusive webinar designed for the Medical Device Engineering Industry on the 11th of November at 10am CET. Robert Ginsberg, QAdvis Co-Founder and COB will be one of the speakers at this webinar. As the medical device industry becomes increasingly competitive, systems and software delivery are emerging as […]
Person Responsible for Regulatory Compliance (PRRC)
One important new requirement in both MDR and IVDR is to have an assigned and dedicated Person Responsible for Regulatory Compliance (PRRC). The PRRC has the responsibility for regulatory compliance for devices on the market, in clinical trials and clinical performance studies. This is conducted by ensuring that the technical documentation and declaration of conformity […]
News in medical technology
The new legislation on medical devices in the EU, MDR and IVDR has greatly influenced the need for the renewal of medical device standards. This need has led to the development of completely new standards, and previous releases have been revised, to reflect the new law (MDR and IVDR) and developments on the international market. […]
IDL Biotech has chosen QAdvis for regulatory guidance and support
QAdvis has signed an agreement with IDL Biotech. We are proud to be a part of this exciting collaboration in which we will plan and conduct clinical studies for the IVD test UBC® Rapid. Based on the results, QAdvis will provide further regulatory guidance and support to IDL with the FDA application. As part of […]