Entries by Johnnie Dahlberg

Importers and Distributors: Pivital roles in MDR and IVDR Compliance

There is a common misconception that only manufacturers need to comply with the Medical Device Regulation (MDR) 2017/745 and/or the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR) . However, MDR/IVDR defines the roles and the responsibilities of “Economic Operators” which includes Importers, Distributors, Authorized Representatives and Manufacturers. An Importer means any natural or […]

We strengthen our team.

A warm welcome to Marie Mathiasson, our new team-member in Kista QAdvis is happy to welcome Marie to our growing team of experienced quality and regulatory consultants. Marie has an extensive background in regulatory compliance within the medical device sector. She has previously worked at the Swedish Medical Products Agency as an investigator of post market surveillance and navigated […]

Does the requirement for an independent person at design reviews no longer apply?

The FDA’s recent implementation of the Quality Management System Regulation (QMSR) introduces significant changes. Notably, one of those changes is that the QMSR does not explicitly mandate the presence of an independent reviewer during design reviews. In the current QSR 820.30 Design Controls, Section (e) Design review, FDA clearly outlines that: “The procedures shall ensure […]

Can supply problems potentially result in shortages of medical devices in hospitals?

In recent years, significant disruptions in global supply chains have had a huge impact on worldwide trade. These disruptions highlight the need for enhanced resilience and adaptability in the procurement processes especially in the medtech industry. The vulnerabilities of our supply chains were notably exposed during the COVID-19 pandemic, which led to unexpected closures of […]