About us

IV MDEV was founded with the mission to provide services to IVD/Medical Devices industry and Testing Labs.

The company has expertise in Quality Assurance and Regulatory requirements, Technical documentation, CE marking, ISO 13485, Risk Management, MDSAP and ISO 17025.

IV MDEV have worked with Notified Bodies, conducting assessments to IVD/Medical Device companies for CE marking and ISO 13485 certification and with Auditing Organizations for MDSAP regulatory audits. The work has been performed in more than 20 countries in Europe, United States and South America.

In the last 2 years the company have worked for a National Accreditation Body, in the field of Molecular Biology, auditing Testing Labs according to ISO 17025.

Recently, IV MDEV started to collaborate with IVD/Medical Device companies providing Technical and Regulatory expertise.