Medical Device Vigilance

Medical Device Vigilance

Medical Device Vigilance

Strengthen the Safety Monitoring of Your Medical Devices and Regulatory Compliance

In a regulatory environment reinforced by the European Medical Device Regulation (MDR), manufacturers, distributors, importers, and operators must ensure continuous monitoring of the safety and performance of medical devices throughout their lifecycle.

Medical Device Vigilance has become a strategic challenge to:

– ensure patient and user safety

– detect incidents and emerging risks

– comply with competent authority requirements

– secure post-market surveillance activities

– maintain regulatory compliance across France and Europe

Atessia Vigilances supports medical device manufacturers and healthcare organizations in the implementation, management, and optimization of medical device vigilance and post-market surveillance systems.

Our objective: to strengthen the safety of your medical devices, secure your regulatory obligations, and ensure compliant healthcare vigilance activities.

Strengthen Your Post-Market Surveillance System

European regulatory requirements impose continuous monitoring of incidents and safety data throughout the entire lifecycle of medical devices.

Atessia Vigilances provides an integrated approach covering:

  • incident and complaint management
  • safety data monitoring
  • MDR regulatory compliance
  • support for Post-Market Surveillance (PMS) obligations
  • security of medical device vigilance activities


A pragmatic and structured approach tailored to the challenges faced by medical device manufacturers and operators.
Ensure the Quality and Traceability of Vigilance Data

Management of medical device incidents requires robust processes to ensure rapid and compliant assessment of reported events.

Our teams support:

  • intake and registration of incident reports
  • assessment of incidents and adverse events
  • follow-up of technical and medical investigations
  • management of additional information requests
  • quality control of collected data
  • coordination with relevant stakeholders


Reliable processes designed to ensure traceability, consistency, and responsiveness in incident management.
Meet Competent Authority Requirements

Manufacturers and operators must ensure reporting of serious incidents and Field Safety Corrective Actions (FSCAs) in accordance with European and national requirements.

Atessia Vigilances supports clients with:

  • medical device vigilance regulatory reporting
  • interactions with ANSM and European authorities
  • management of Field Safety Corrective Actions (FSCAs)
  • drafting of Field Safety Notices (FSNs)
  • monitoring of MDR regulatory obligations
  • control of regulatory reporting timelines


Regulatory expertise designed to reduce the risk of non-compliance and secure your European obligations.
Strengthen Your Post-Market Surveillance Activities

Post-market surveillance is a central pillar of the European MDR framework and medical device lifecycle management.

Our experts support:

  • implementation of PMS systems
  • collection and analysis of field safety data
  • monitoring of trends and signals
  • Post-Market Clinical Follow-up (PMCF) activities
  • preparation of PMS reports and Medical Device PSURs
  • benefit-risk evaluation of medical devices


A proactive surveillance approach designed to strengthen the safety and performance of your medical devices.
Secure Field Data and Quality Processes

Quality complaints are a major source of safety information and must be integrated into the medical device vigilance system.

Atessia Vigilances supports:

  • product complaint management
  • assessment of potential incidents
  • quality trend analysis
  • coordination with technical and quality teams
  • follow-up of corrective and preventive actions (CAPAs)


A structured field data management approach designed to strengthen product surveillance and regulatory compliance.
Prepare Your Organization for Audits and Regulatory Inspections

Health authorities pay particular attention to the robustness of post-market surveillance and medical device vigilance systems.

Atessia Vigilances supports organizations with:

  • MDR compliance reviews
  • quality and vigilance audits
  • preparation for regulatory inspections and audits
  • procedural and documentation reviews
  • gap assessments and CAPA plans
  • protection of critical activities


Systems designed to be compliant, robust, and inspection-ready.
Strengthen the Expertise of Your Teams

Strong knowledge of MDR requirements and medical device vigilance best practices is essential to ensure organizational compliance.

We provide tailored training programs for:

  • quality teams
  • regulatory affairs departments
  • vigilance and product safety teams
  • customer service and technical support teams
  • manufacturers and distributors


Our programs cover:

  • fundamentals of medical device vigilance
  • MDR regulatory obligations
  • incident and FSCA management
  • post-market surveillance
  • documentation and quality best practices


Operational training programs designed to sustainably strengthen regulatory compliance and expertise.
Processes Designed to Ensure Safety and Compliance

Our medical device vigilance activities are integrated into a structured quality framework compliant with European requirements.

We ensure:

  • documented and auditable procedures
  • full traceability of activities
  • robust methodologies
  • appropriate quality controls
  • risk-based approaches


An organization designed to sustainably secure your medical device surveillance activities.

Why Choose Atessia Vigilances ?

Experienced consultants specialized in medical device vigilance, healthcare safety, and regulatory compliance.

Compliance with MDR, ANSM, and European authority expectations.

Solutions tailored to the operational realities of medical device manufacturers and operators.

Systems and processes designed to support regulatory audits and inspections.

Systems and processes designed to support regulatory audits and inspections.

What You Gain by Working with Us

– Strengthened safety of your medical devices
– Reduced regulatory risk
– Enhanced post-market surveillance activities
– Secured healthcare vigilance data
– Improved preparedness for audits and regulatory inspections

Looking for an Expert Partner in Medical Device Vigilance?

Atessia Vigilances supports medical device manufacturers and healthcare organizations in structuring, managing, and securing medical device vigilance and post-market surveillance activities.

Contact us