Entries by Johnnie Dahlberg

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 […]

Join us at the Swedish Medtech Regulatory Summit on 14 March 2024

QAdvis will attend the yearly Regulatory Summit hosted by Swedish Medtech. This year Robert Ginsberg and Cecilia Emanuelsson will be two of the speakers. We look forward to attending this annual meeting and to be a part of the presentations and meet all the participants. Cecilia Emanuelsson and Robert Ginsberg will share their knowledge and […]

Regulators will regulate, and AI is on top of their list.

The EU AI Act will become the world’s first broad legal framework for artificial intelligence and could hopefully become a global standard. It will apply to any business operating within the EU or offering AI systems or services to EU residents. The use of artificial intelligence in the EU will be regulated by the AI […]