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Verifarma is an Integral solution allowing the manufacturers of medical devices to manage labels, reports and quality requirements for the compliance with the European regulation on medical devices and medical devices for in vitro diagnostic use (IVDR).
Verifarma comprehensive set of solutions serves Medical Devices manufacturers to manage labeling, reporting and quality requirements in order to ensure the compliance for upcoming EU Regulations for medical devices (MDR), in vitro diagnostic medical devices (IVDR) and improve their processes for patient safety.
New EU Regulation for Medical Devices
(adopted on April 5th 2017 and published March 5th 2017)
Medical Devices Regulation (MDR)
In vitro Diagnostic Regulation (IVDR).
Main changes of the new regualtion
Verifarma MD is a smart, effective and flexible solution focused on generating the scalability organizations need for deployment while ensuring consistency, accuracy and security across data.
Verifarma MD - UDI Managementread more
Verifarma MD - UDI Management
Enterprise Labeling Solution for the Medical Device Industry. It solves the challenge of generating and printing the information (UDI) on the label/packaging of the device.
Verifarma MD - EUDAMEDread more
Verifarma MD - EUDAMED
On boarding and reporting of relevant information to the corresponding entities. It solves the challenge of reporting the relevant information (UDI, data, documents) to Eudamedand to suitable business partners.
Verifarma Qualityread more
Quality Management System Module. It solves the challenge of establishing a system to ensure data quality.
¿What is the UDI?
UDI = UDI DI + UDI PI
Manufacturer and product ID.
Batch, serial, informatic program, expiration date (or date of manufacture).
Basic UDI DI
- UDI-DI is the access code for information related to the device entered in EUDAMED.
- Reference to basic UDI-DI in the key documentation (declaration of conformity, certificates).
- Report serious incidents and corrective safety actions.
- Storage of the UDI for implantable MD Class III.
UDI Support = ICAD + HRI
ICAD / AIDC
Aplication MDR: UDI allocation, registered and Eudamed
Marking UDI Class III
Marking UDI Class II
Marking UDI Class I