AUREVIA

Aurevia Medtech Compliance (formerly QAdvis)

@aurevia_qara

Kista
http://www.aurevia.com
Medical Equipment Manufacturing

Overview

About Aurevia Medtech Compliance (formerly QAdvis)

Aurevia provides quality assurance and regulatory affairs (QARA) expertise covering the entire lifecycle of medical devices and in vitro diagnostic medical devices (IVDs), from early development to post-market phases globally. Additionally, Aurevia operates as a full-service contract research organization (CRO) supporting pharmaceuticals, medical devices, and IVDs. Aurevia was formed in 2025 when QAdvis, Kasve, Mectalent Medical Services, Lean Entries, Scandinavian CRO, Artimed, Clinical Consulting, and P.R.I.S.M.A. CRO merged.

We understand the challenges of navigating the complex landscape of medical and in vitro diagnostic device development and market surveillance. Transforming a concept into a market-ready medical device requires a strategic and systematic approach. With a proven track record of successful projects, we are ready to share our insights and support you throughout the development, market launch and the post market surveillance of your medical device.

Whether you are a startup or an established organization, our expertise spans across various medical devices and device classes. We collaborate closely with you and help you to turn your vision into reality, mitigating risks and optimizing the timelines.

Feel free to contact us at +46 (0)8 621 01 05, [email protected] or just drop us a message here on LinkedIn. We will get back to you shortly.

Headquarters

Kista

Website

http://www.aurevia.com

Company Size

51-200 employees

Industry

Medical Equipment Manufacturing

Company Type

Privately Held

Founded

2013

Specialties

Medical Device regulations, CE - marking, FDA and QSR, MDR, IVDR, IVDD, MDD, IEC 62304, ISO 13485, IEC 62366-1, Software, Clinical Evaluation, STED, Regulatory, Quality, UK Responsible Person, European-authorized-representative, Due Diligence, ISO 14971, Performance Evaluation, Risk Management, Software as Medical Device, and Usability

Posts