About AARQK

AARQK was conceived to address a need of manufacturers for quality support in understanding and implementing the new regulatory requirements of the European Union’s Medical Devices Regulation (MDR), after it came into effect in 2017.

With clinical data and patient safety central to the new MDR requirements, expert clinical regulatory support became crucial for manufacturers in the re-registration and ongoing lifecycle activities of their marketed medical devices, as well as for the evolution of these products and the development of new and innovative medical devices that provide enhanced patient benefits and redefine the current State of the Art.

Accordingly, in January 2021, AARQK was founded, with a goal to delivering the best outcomes for manufactures and patients,
by delivering state-of-the-art clinical regulatory consulting support, for novel and established state-of-the-art medical devices.

AARQK’s ethos is that the best outcomes come when experts can be experts. Therefore, AARQK focuses on delivering expert state-of-the-art clinical regulatory support for the EU market, so manufacturers can focus on manufacturing expert state-of-the-art medical devices. Furthermore, through the AARQK network and partners, AARQK can facilitate manufacturers to receive expert support across the product lifecycle, including CRO services for clinical investigations, and for product registrations in the US and ROW. 

If you are a clinical expert that would like to become a part of AARQK’s network, or an established service provider that is interested in engaging AARQK as a clinical regulatory Functional Service Partner, contact AARQK.