Entries by Johnnie Dahlberg

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 […]

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 […]