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Materiovigilance Solutions

Raising the bar for safety.

In the Medical Device industry.

Medical Devices’ numbers increased significantly over the past years, and their diversity and complexity increased equally. Unsurprisingly, this also meant an elevation in the number of Adverse Device Incidents.

As a result, the regulation of Medical Devices also progressed. All over the globe, companies now undertake various measures to provide better patient safety.

The availability of a proactive and comprehensive vigilance system is a must for manufacturers of specific Medical Devices in the EU or US. Furthermore, if the MA holder is also the device component manufacturer, vigilance systems for combination therapies must meet the regulatory requirements of both these components.

Related services:

Safety Throughout Clinical Development.

Medical Device Vigilance experts who are ready to help you meet patient safety requirements.

A complete solution for Materiovigilance

Materiovigilance, or Medical Device vigilance, concerns collecting, assessing, reporting and identifying trends in incidents following the use of medical devices. Its primary objective is to ensure patient safety by preventing or reducing the likelihood of reoccurring Adverse Device Effects.

Biomapas offers to support comprehensive Materiovigilance services across EU and non-EU countries. Our highly experienced team of safety professionals combines global and local experience. As a result, it can create a thorough and robust local medical device system to fulfil manufacturers’ obligations and ensure all incidents are collected and reported per national requirements.

Materiovigilance Activities

  • Medical Device safety consultancy;
  • Creation and maintenance of local standard Operating Procedures (SOPs);
  • Adverse Device Effects (ADE) and Medical Device Incidents (MDI) intake, follow-up and reconciliation;
  • Submission of Adverse Device Effects (ADE) / Medical Device Incidents (MDI) to local Competent Authorities;
  • Literature Monitoring for identification of medical device incidents for combined products;
  • Writing and/or reviewing Materiovigilance Agreements;
  • Implementation and Reporting of Field Safety Corrective Actions;

8 + 13 =

Martijn van de Leur

Martijn van de Leur

Head of Global Pharmacovigilance

Martijn van de Leur has over 15 years of experience in pharmacovigilance. Throughout his career in big pharma, Martijn went from entry-level positions in safety data management to senior medical advisory roles within the Clinical Risk Management teams. He also helped his companies to develop their PV systems through multiple massive company merger integration projects. Before joining Biomapas, Martijn held several executive roles as (Deputy) EU QPPV, Global Head of PV Compliance and Global Head of PV Technologies.

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