IV MDEV has an in-depth experience of the requirements and perspectives of Manufacturers and Laboratories, but also the ones for Notified Bodies and Auditing Organizations, enabling a wide experience of solutions based on both perspectives. Our competences and solutions cover European Regulatory requirements (IVDD 98/79/EC, IVDR 2017/746, MDD 93/42/EEC, MDR 2017/745), Medical Devices Single Audit Program (MDSAP), Standards and guidance documents such as ISO 13485, ISO 14971, ISO 9001, CLSI, MEDDEV, IMDRF/GHTF and MDCG documentation.
Currently, most of the IVD organizations are preparing themselves for the transition to IVDR, and 80-90% of all CE marked product will require assessment by NBs and review of technical documentation. IV MDEV supports the transition, assessing the QMS and Technical documentation.
Additionally, the company provides solutions for Accredited testing Labs, conducting Audits, gap assessments or support on Validation of assays.