Medical Devices 2019-09-13T12:06:49+00:00

Verifarma
Medical Devices

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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)

  • Directive 90/385/CEE about active implantable medical devices
  • Directive 93/42/CEE about medical devices

Medical Devices Regulation (MDR)

  • Directive 98/79/CE about in vitro diagnostic medical devices

In vitro Diagnostic Regulation (IVDR).

Main changes of the new regualtion

  • Inclusion of certain esthetic devices within the scope.

  • Minimum EU requirements related to single use reprocessing.

  • Stronger pre-market control of high-risk DM with MDCG.

  • Reinforcement of the rules on clinical evaluation and research.

  • Reinforced designation and supervision processes of notified bodies.

  • Establishment of an extensive EU database on medical devices (EUDAMED), much of the information will be made available to the public.

  • Introduction of a UDI system.

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 Management

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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.

• Assign identification numbers to all devices and packaging levels including kits, complex systems and combination products.
• Generate Serial Numbers / Batch Number.
• Manage Master data within the framework of UDI: define data carrier and content.
• Support on getting membership with an issuing agency (e.g. GS1, HIBCC) to obtain a company code.
• UDI management.
• Assign a new UDI-DI when needed.
• Automatic connection with printers, labels or production lines.
• Storage and data management.

Verifarma MD - EUDAMED

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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.

• Centralize and manage information.
• Report to Eudamed.
• Automated interfaces to relevant business partners to exchange information.
• Integration with your ERP or WAMAS system.
• Long-term data storage and administration.
• Keep data up-to-date.

Verifarma Quality

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Verifarma Quality

Quality Management System Module. It solves the challenge of establishing a system to ensure data quality.

• Establisha system to ensure data quality.
• Implementa change control process for new and modified data.
• Manageof SOP (Standard Operating Procedures).
• Program/Eventstracking.
• Internaland external audit management.
• Risk management.
• Localize potential gaps in compliance with related requirements..
• Quality claims handling.
• Partners Qualification (GMP).

¿What is the UDI?

UDI = UDI DI + UDI PI

UDI DI
Manufacturer and product ID.

UDI PI
Batch, serial, informatic program, expiration date (or date of manufacture).

Basic UDI DI

USE

  • 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

HRI

Principales Plazos:

Regulations published

Aplication MDR: UDI allocation, registered and Eudamed

Marking UDI Class III

Aplication IVDR

Marking UDI Class II

Marking UDI Class I