Entries by Johnnie Dahlberg

ISO 13485:2016 Certification achieved!

We are delighted and proud to announce that QAdvis Group has achieved ISO 13485:2016 certification. This is a major milestone and demonstrates our commitment to provide high quality consulting services and we are now better positioned to consistently meet and exceed our clients’ expectations.

Welcome to us Kecke Elmroth

With a solid background from Medical Affairs in MedTech industry and academic Life Science research, Kecke is skilled in clinical/scientific reading, writing, and interpretation. She is well-experienced in clinical evaluation, post-market clinical follow-up, clinical evidence gap identification, systematic literature search, and claims substantiation for regulatory purposes. Kecke is used to provide Medical Affairs input to […]

Is UDI for medical devices as complicated as it seems?

Purpose of implementing a device identification system is to improve patient safety by making the traceability of devices more efficient and simplify a FSCA (Field Safety Corrective Action) e.g. recall of devices. In parallel, the post-market safety-related activities for devices will also be more robust and allow a better monitoring by the competent authorities. UDI, […]

Welcome onboard Sneha Bangalore

After 4 months of internship at QAdvis we are now happy to welcome Sneha to the QAdvis Team as a consultant. Sneha has during her internship gained an overview insight of Quality and Regulatory consulting and will now continue to act as support within certain projects. Sneha contributes with her positive attitude, a quick understanding […]