MD + IVD Regulatory Services & Competitive Intelligence
We support medical device companies for:
- CND-EMDN coding
- registration of products in Italy and in Eudamed
- preparing the technical dossiers for CE mark, UKCA mark, FDA approval, and Latin America certifications
- MDR and IVDR compliance
- quality management.
We possess a unique Database for competitive and business analyses
Over 15 years in the making using publicly accessible sources, our Database includes technical information on all medical / IVD devices on the European and the US Markets.
Our Database’s unique selling points
- It is the largest in the world on medical / IVD devices, since it includes data on about 6 million products on the European and the US Markets.
- It is based on a 13-hierarchical-level classification system, with up to 37 technical and functional specifications for each device. View here an example of the structure of the MeDGloX Database.
- It is updated daily with outstanding care and competence by trained staff members.
- It is fully compliant with EMDN.
- It has a fast and user-friendly engine which allows different types of live searching.
We strongly believe in the power and value of data for decision making.
We aim to support both companies to be compliant with regulatory requirements, and buyers to perform better.
All our team members have long experience, deep knowledge of the sector and solid reputation at international level so as to ensure the highest standards of service to our customers.