In Vitro Diagnostics (IVD) and Medical Device Lifecycle Management refer to the comprehensive processes involved in the development, approval, manufacturing, monitoring, and maintenance of medical devices and diagnostic products throughout their entire lifespan.
Performance Evaluation is a critical regulatory and scientific process that demonstrates the safety, quality, and effectiveness of In Vitro Diagnostic (IVD) devices throughout their lifecycle. It ensures that an IVD performs as intended and delivers accurate, reliable, and clinically meaningful results.
A European Authorized Representative (EC REP) is a legal entity established within the European Union (EU) that acts on behalf of a non-EU manufacturer of medical devices, in vitro diagnostics (IVDs), or other regulated products. The EC REP ensures that the manufacturer complies with applicable European regulations such as EU MDR (2017/745) and IVDR (2017/746).
Medical Device Translation Services ensure that technical, regulatory, and user-related documents are accurately translated for global markets while maintaining compliance with international standards. These services support manufacturers in communicating critical information clearly across different languages and regions.