Novarum MDRQ

Novarum MDRQ is a specialized global consultancy firm providing comprehensive regulatory and quality services to the medical device and in-vitro diagnostic (IVD) industries. The firm focuses on helping manufacturers navigate the increasingly complex global regulatory landscape, particularly the transition to the European Union's Medical Device Regulation (MDR) and In-Vitro Diagnostic Regulation (IVDR). The company offers strategic advisory services for market entry, including US FDA 510(k), De Novo, and PMA submissions, as well as international registrations in markets like Canada, Australia, and Japan. They also provide hands-on support for Quality Management System (QMS) implementation, auditing, and clinical evaluation report (CER) development.