QAdvis is a solution-oriented trusted service provider for the medical device and in vitro diagnostic device sector. To enable and maintain global market access, we can with high level of knowhow and expertise within quality management and regulatory affairs support your company to be in compliance with applicable regulations and requirements. QAdvis was founded in 2013 and is based in Sweden. We are certified according to ISO 13485:2016.
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 […]
It will happen to you too.
Maybe not today or tomorrow, but it will happen, an unannounced audit from your Notified Body. Unannounced audits by the Notified Body (NB) are performed without any prior notice or schedule. The auditor can show up at any time and expect to have access to your premises and documentation related to your medical devices, including […]
Does quality and regulatory pose a challenge to Innovation?
Quality and Regulatory Affairs is often regarded as being a hindrance to innovation. We think this is a very counterproductive way of looking at it. We see the QMS more like the barrier between the opposite lanes of the motorway preventing you from a head on collision in case of an innocent mistake. Sweden is […]