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.
Do you as a medical device manufacturer consider the intended environment of use when you design alarm sounds?
Based on experience in emergency/intensive care and equally within the medical device industry, we have learned that some companies have difficulties to clearly define the circumstances where the devices are intended to be used. It is common that same type of device can be used in a multitude of different environments. So why does this […]
Whenever you see a successful business, someone once made a courageous decision.
The above is a quote from Peter Drucker (1909 – 2005) the founding father of modern management studies. And nothing could be more true, especially if you decide to start a business in the medical device consulting industry. That is exactly what Robert Ginsberg and Nils-Åke Lindberg did in 2013 when they founded QAdvis AB. […]
Why having a second supplier could make sense even if it costs more.
Having dual sourcing of important components causes additional work, takes more time and negotiation price could be less successful with half the volumes. If you add this to the fact that you also double your suppliers with additional supplier control, validations and possible Notified Body involvement, the natural question would be: Why on earth would […]
IVDR Application Process – What do you need to know?
QAdvis have invited Charlotte Hess from BSI to give us some “need-to-know” when you plan for your IVDR-Application. Charlotte has solid knowledge of the IVD industry and understands the complexity of the IVDR applications. Whether you’re starting the certification process, looking to transfer or just need to discuss options for your business, she can guide […]
Local representative and what you need to know
Several countries require an in-country representative. This company is often chosen by the marketing department to market and distribute the medical devices in the country. But is this really the best strategy when it also includes being the regulatory contact with the authorities? The marketing department is without doubt the best department to choose sales […]