About us

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

The founder of the company, Manuel Rodrigues, became an entrepreneur in 2003 and during 13 years has implemented a flexible scope ISO 17025 accreditation and a ISO 13485 certification for D&D and Manufacture of IVD products. Additionally, was responsible for D&D and preparation of Technical documentation, and designed and setup a Diagnostics manufacturing facility for the Clinical, Veterinary and Food sectors.

Since 2016 has been working with Notified Bodies, conducting assessments to IVD/Medical Device companies for CE marking and ISO 13485 certification, as well as with Auditing Organizations for MDSAP regulatory audits. The work has been performed in more than 20 countries in Europe, United States, South America and Africa.

Since 2018, the company have worked for a National Accreditation Body, in the field of Molecular Biology, auditing Testing Labs with ISO 17025 accreditation.

In 2020, during the COVID-19 pandemic, IV MDEV collaborated with IVD/Medical Device companies providing Technical and Regulatory expertise.