Medical Devices

As the complexity of medical devices increases, so does the need for robust vigilance services.

FGK PV Services for Medical Device Vigilance

Our Vigilance services can be added to an existing program on a modular basis or offered as a full-scope vigilance support. They are designed to support manufacturers throughout the lifecycle of their medical devices and include, but are not limited to:

Safety Reporting

One of the primary functions of vigilance services is the processing and reporting of individual case safety reports (ICSRs) and ensuring timely submissions to regulatory authorities.

Signal Detection

We conduct signal detection activities to identify potential safety issues of your product. This involves analyzing data from various sources to assess the risk associated with specific devices.

Regulatory Compliance Support

We assist companies in navigating the complex regulatory landscape. We provide guidance on compliance requirements, help prepare necessary documentation, and ensure that all submissions meet regulatory standards.

List of all services

1. Before Marketing Authorization Application (MAA)

We offer

  • EV account setup
  • SDEA / PVSA / safety contracts development
  • Literature search and regulatory intelligence strategy setup
  • Signal detection strategy setup
  • QPPV assignment
  • PSMF creation and maintenance
  • Global PV database and setup
2. During and after MAA

We offer

  • PSMF updates
  • Conduct of regular literature search and regulatory intelligence
  • Conduct of signal detection (case and aggregate level reports)
  • ICSRs (EU and ROW) processing, medical assessment, submissions
  • CPPV network setup
  • ESI management
3. From MA until Product Launch

We offer

  • Continuous service provision
  • Inspection readiness
  • PSUR / PBRER development
  • Periodic QPPV teleconferences
4. After the Launch

We offer

  • Continuous service provision
  • CPPV network setup
  • Conduct of local literature search and regulatory intelligence
  • RMiM effectiveness assessment

Partnering with FGK Pharmacovigilance can provide significant advantages for device manufacturers:

Access to FGK’s Expertise

By partnering with a specialized vendor, device manufacturers gain access to a wealth of knowledge and experience. FGK Pharmacovigilance employs physicians and professionals with extensive backgrounds in device vigilance, regulatory affairs, and clinical research. This expertise is invaluable in navigating the complexities of vigilance requirements.

Cost-Effectiveness

Outsourcing can be a very cost-effective solution for many manufacturers. Maintaining an in-house vigilance team requires significant investment in training, technology, and personnel. By outsourcing, companies can reduce overhead costs while still ensuring highest compliance with regulatory standards.

Enhanced Focus on Core Activities

Outsourcing vigilance services allows organizations to concentrate on their primary business activities. By delegating compliance-related tasks to experts, device manufacturers can allocate more resources to product development, marketing, and other critical areas.

Improved Compliance and Risk Management

FGK Pharmacovigilance is well-versed in the latest regulatory requirements and best practices of medical device vigilance. Our expertise can help organizations avoid costly compliance issues and mitigate risks associated with adverse events.

Manufacturers must navigate a myriad of regulations across different markets, making it challenging to maintain conformity. Therefore, outsourcing Medical device vigilance is a strategic approach that offers numerous benefits to manufacturers.

Choosing the Right Vigilance Partner is critical to the success of a vigilance program.

FGK Pharmacovigilance has a proven track record in medical device vigilance and offers tailored solutions that align with YOUR specific requirements, ensuring that you receive the support necessary for your product’s market success.

Zurab Koberidze, M.D., Ph.D., MPH

Director Pharmacovigilance, QPPV

Effective communication is vital for successful outsourcing relationships. We prioritize transparency and collaboration, ensuring that you remain informed and engaged throughout the process.

Book your free consultation now:

Legal framework

The legal framework of our device vigilance services for medical devices marketed within the EU is provided by Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR), including their implementing and delegated acts, as well as applicable MDCG guidance documents, including those related to vigilance, serious incident reporting, field safety corrective actions (FSCAs), trend reporting, and the use of EUDAMED.

For devices placed on the market under Directives 93/42/EEC, 90/385/EEC, and 98/79/EC, the vigilance requirements of the MDR and IVDR apply.

Furthermore, applicable national legislation and competent authority requirements of the respective EU Member States form part of the framework for the conduct of our device vigilance activities.

In accordance with the gradual roll-out of EUDAMED and until the vigilance module becomes available and mandatory, vigilance reporting is performed through the applicable national competent authority channels.