MakroCare got selected by a global Top 10 medical device company for upcoming MDR and Rev 4 compliance program. With major changes anticipated for upcoming MDR, this global company knew well an external partner who can align well with their overall goals to help them meet short and long-term goals is vital for their strategy. To start with, to meet current compliance needs of Rev 4 clinical evaluation, a set of products are assigned to MakroCare for gap analysis and updates. MakroCare assigned a dedicated experienced team of scientific analysts, writers, biomedical experts, and a medical advisor.
MakroCare MedTech center of excellence (COE) has been providing clinical, regulatory and medical services to device and diagnostics clients for over a decade now. As device regulatory landscape is changing with MDR introduction, MakroCare has been supporting several device companies in advisory, impact analysis, clinical programs, setting up Registry and PMCF clinical studies, review existing clinical data and labeling areas. One of the key strengths of MakroCare is pooling right resources and expertise from USA, Europe and also from some cost effective locations to offer unparallel, cost efficient value proposition to these device companies.