About us

MIQARA Consulting is a Swedish Quality Assurance & Regulatory Affairs (QARA) company for medical devices, in-vitro diagnostics, SaMD, combination products, and custom made devices. Our primary focus is to provide flexible solutions and help you navigate the regulatory universe. 

Utilizing our long experience in QARA, we assist companies in understanding the complex regulatory landscapes, decreasing risks of incompliance, and optimising processes to bring products to market efficiently.

Since 2008 we have been active in standardisation development work within ISO for many process and product standards crucial for the MedTech Industry.

We have a selected network of collaboration partners if needed.