Helping companies and consultants achieve faster EU MDR compliance

Testimonial

“Medical Device and In-Vitro Diagnostic Regulations have undoubtedly raised the bar for safety and quality in the European medical technology sector. However, the increased complexity, costs, and unpredictability associated with MDR and IVDR are creating significant challenges for manufacturers, particularly SMEs, and are slowing down the pace of innovation in Europe, risking also the availability of long-standing legacy devices.”