News from QAdvis

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 […]

Update on situation with Covid-19

The ongoing situation with Covid-19, with the extended time range on recommendations to work from home from Sweden’s Public Health Agency also maintains our limitations regarding visitors in our office premises. In order to eliminate any risk of QAdvis hosted events or QAdvis employees becoming a source of risk for clients and colleagues, we have […]