It provides international Consulting services for companies involved in the creation, production, distribution, import and export of Medical Devices and in-Vitro Diagnostic Medical Devices.
It Distributes a wide range of Medical Devices and in-Vitro Diagnostic Medical Devices internationally, carefully selecting the manufacturers based on the current regulations and certifications.
In collaboration with doctors and specialists in every biomedical sector, it promotes the Research & Development of Medical Devices and in-Vitro Diagnostic Medical Devices, meeting both patients and users needs.
- European Certification (CE)
- 510(k) Premarket Notification Clearances
- Regulation 2017/745/EU
- Technical Documentation (TD)
- Declaration of Conformity (DoC)
- Repertoire and Databank Registration (RDM)
- Plan, Do, Check, Act (PDCA)
- Standard Operating Procedure (SOP)
- Preventice and Corrective Actions (CAPA)
- Field Safety Notice (FSN)
- Field Safety Corrective Action (FSCA)
- Installation Qualification (IQ)
- Operational Qualification (OQ)
- Performance Qualification (PQ)
- Clinical Evaluation Plan (CEP)
- Clinical Evaluation Repot (CER)
- Clinical Investigation (CI)
- Clinical Development Plan (CDP)
- Summary of Safety and Clinical Performance (SSCP)
- Declaration of Interest (DoI)
- Risk Management Plan (RMP)
- Risk Management Report (RMR)
- Risk Analysis (RA)
- Failure Mode and Effect Analysis (FMEA)
- Authorized Representative (AR)
- Manufacturer (OEM)
- Distributor (DSRB)
- Importer (IMPR)
- Natural or Legal Person (NLPR)
- Post-Market Surveillance Plan (PMSP)
- Post-Market Surveillance Report (PMSR)
- Periodic Safety Update Report (PSUR)
- Post-Market Clinical Follow-Up Plan (PMCFP)
- Post-Market Clinical Follow-Up Report (PMCFR)
- Authorized Representative (CA)
- Notified Body (NB)
- Economical Operators (EO)
- Global Harmonization Task Force (GHTF)
- International Medical Devices Regulators Forum (IMDRF)
- Medical Device Coordination Group (MDCG)
- EUDAMED
- Device National Classification (CND)
- Universal Medical Devices Nomenclature System (UMDNS)
- Global Medical Device Nomenclature (GMDN)
- Italian Health Ministry (IHM)
- Federal Institute for Drug and Medical Devices (BfArM)
- Standards (STD)
- Guidelines (GDL)
- Common Specifications (CS)
- General Safety and Performance Requirements (GSPR)