Expertise​​​​​​

 

 

IV MDEV has an in-depth experience of the needs of the Industry and the requirements from Notified Bodies and Auditing Organizations. Our competences 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, or MDCG / IMDRF / CLSI documentation.

Additionally, the company provides solutions for Accredited testing Labs, conducting Audits, gap assessments or support on Validation of assays.